USOO8685381 B2

(12) United States Patent (10) Patent No.: US 8,685,381 B2 Schlessinger et al. (45) Date of Patent: Apr. 1, 2014

(54) TOPICAL BASE AND ACTIVE 4,346,086 A 8, 1982 Sattler et al...... 514f179 AGENTCONTAINING COMPOSITIONS, AND 25.6; A . 3. signe et al. . :g - ww. Oil ...... E. RMPROVING AND 4,393,044 A 7/1983 Takada et all ... 424/64 4.478,853. A 10, 1984 Chaussee ... 514,772 4496,554 A 1/1985 Wong...... 514, 179 (76) Inventors: Joel Schlessinger, Omaha, NE (US); 4,504,465. A 3/1985 Sampson et al. ... 424/65 Daniel Isaac Schlessinger, Omaha, NE 4,610,978 A 9, 1986 Dikstein et al. 51446 (US) 263 A 38; unniSNi et A" 33 c 4,702,916 A 10, 1987 Geria ...... 424/400 (*) Notice: Subject to any disclaimer, the term of this 4,847,069 A 7, 1989 Bissett et al. . ... 424/47 patent is extended or adjusted under 35 4,847,071 A 7, 1989 Bissett et al. . 424,59 U.S.C. 154(b) by 0 days. 4,847,072 A 7, 1989 Bissett ...... 424,59 4,879,274 A 11, 1989 Kamiya et al. ... 424/780 (21) Appl. No.: 13/233,012 is: A 1982 alm 5:8: 4,902,682 A 2f1990 Sattler ...... 514, 179 (22) Filed: Sep. 14, 2011 4,996,044 A * 2/1991 Mercado et al. ... 424/64 5,061,700 A 10, 1991 Dow et al...... 514,169 (65) Prior Publication Data 5,185,150 A 2f1993 DeLuca et al. ... 424/401 5,254,109 A 10, 1993 Smith et al...... 604,289 US 2012/O237.556A1 Sep. 20, 2012 5,290,561 A 3, 1994 Farhadieh ...... 424/449 5,292,512 A 3, 1994 Schaefer et al. ... 424/401 5,543,148 A 8/1996 Lapidus ...... 424/401 Related U.S. Application Data (Continued) (63) Continuation-in-part of application No. 12/925,464, OTHER PUBLICATIONS filed on Oct. 23, 2010, now abandoned. Fancol VB search result in Google showing date that the web page (51) Int. Cl. was published. Available online Feb. 11, 2009; downloaded Feb. 9. A6 IK 8/49 (2006.01) 2012.* A63/74 (2006.01) Finsolv TN search result in Google showing date that the web page CO7I5/00 (2006.01) y published Available online Jun. 7, 2010; downloaded Feb. 9, C07J 7/00 (2006.01) Natunola Castor 1023 search result in Google showing date that the (52) U.S. Cl. web page was published. Available online as early as Jul. 19, 2007; USPC ...... 424/78.02; 424/59: 424/63; 424/64; downloaded Feb. 9, 2012.* 424/70.16; 424/70.9: 424/78.03; 424/78.05: Fancol VB data sheet, published online Feb. 11, 2009; downloaded *79:29:29:27:552/559:552/569,552.570; 552,577 ENYSE:A Splodesheetablished luct sheet, published online Jun.in 7, 2010.2010; down (58) Field of Classification Search oaded NOV. f. ZU12. None (Continued) See application file for complete search history. Primary Examiner — Robert A Wax (56) References Cited Assistant Examiner — Jeffrey T Palenik (74) Attorney, Agent, or Firm — Roberta L. Hastreiter; Keith U.S. PATENT DOCUMENTS D. Parr; Locke Lord LLP 3,644,613 A 2, 1972 Moeller et al...... 424/49 (57) ABSTRACT 3,914, 131 A 10, 1975 Hutchison ...... 106,268 3,947,571 A 3/1976 Murphy et al...... 424,64 The invention provides skin protecting and penetrating, easy 3,954,114. A 5/1976 Ostrowsky et al. . ... 132,88.7 to-administer base and active agent-containing compositions, 3,957,969 A 5/1976 Fujiyama ...... 424,64 Such as those including hydrocortisone, for treating the skin 3,960,757 A 6, 1976 Morishita et al. ... 427,213 3,976,789 A 8, 1976 Tomita et al...... 424/365 of mammals for different dermatologic disorders. This is 3,981,996 A 9/1976 Leigh ...... 514,169 effected by topically administering effective amounts of the 4,048,309 A 9, 1977 Chen et al. ... 424,238 compositions thereto in forms that address the skin and 4,060,492 A 11, 1977 Yasui et al. .. 252/59 mucosa of the mouth and lips, and the rest of the body. 4,066,789 A 1/1978 Mores et al. . ... 424,635 Additionally, an optional flavoring addition to these products 4,078,147 A 3, 1978 Ukai et al...... 560,180 affords significantly better tasting, and less bitter, composi 4,137,302 A 1/1979 Humbert et al. ... 424/47 tions, allowing a more pleasant experience and better com 4,151,272 A 4/1979 Geary et al. . ... 424/68 4,177.267 A 12/1979 Herschler ...... 424,238 pliance by patients. The compositions include a unique for 4,199,576 A 4, 1980 Reller et al. ... 424,230 mulation of FANCOL VB, Natunola Castor 1023, Finsolv 4,226,889 A 10, 1980 Yuhas ...... 424,59 TN, bees wax and, optionally, one or a plurality of plant or 4,229,432 A 10, 1980 Geria ...... 424/68 plant seed oils, fatty alcohols, fats and flavorings, in desirable 4.252,796 A 2f1981 Yu et al. ... 514, 181 weight percents thereof, in various forms, and preferably in a 4,284,630 A 8, 1981 Yu et al...... 514f179 4,291,018 A 9/1981 Oeda ...... 424,64 form of a solid roll-on Stick in a variety of sizes and of ajar or 4,292,088 A 9/1981 Scheuffgen ...... 106,268 pot. 4,299,828 A 11/1981 Wang et al...... 424,238 4,305,961 A 12/1981 Tsutsumi . ... 424/361 52 Claims, 19 Drawing Sheets 4.322,400 A 3/1982 Yuhas ...... 424,59 (19 of 19 Drawing Sheet(s) Filed in Color) US 8,685,381 B2 Page 2

(56) References Cited 2003.0099604 A1 5/2003 Light 2003. O199838 A1 10, 2003 Sheridan U.S. PATENT DOCUMENTS 2003/0232091 A1 12/2003 Shefer 2004/0091539 A1 5, 2004 Lindahl et al. 5,622,993 A 4/1997 McGinity ...... 514,626 2004/O151671 A1 8, 2004 Abram et al. 5,653,989 A 8, 1997 Sattler ...... 424/401 2004/0202725 A1 10, 2004 Dascalu 5,660,839 A 8, 1997 Alec et al...... 424/401 2004/0235803 A1 11, 2004 Britten 2005/0O25729 A1 2/2005 Groteluschen et al. 5,756,014 A 5/1998 Mathur ...... 264/4.1 5,785,976 A 7, 1998 Westensen 424/400 2005.0054991 A1 3/2005 Tobyn 5,804,572 A 9, 1998 Blank ...... 514f159 2005/0226903 A1 10/2005 Rogasch et al. 5,951,991 A 9/1999 Wagner ... 424/401 2005/0249774 A1 11/2005 Pauletti 5,961,997 A 10, 1999 Swinehart 424/401 2006, OO18933 A1 1/2006 Vaya 5,972.361 A 10, 1999 Fowler ..... 424/402 2006, OO18937 A1 1/2006 Friedman et al. 5,976,555 A 11/1999 Liu ...... 424/401 2006, OO52353 A1 3/2006 Johnson 5.990,100 A 1 1/1999 Rosenberg et al. 514,174 OTHER PUBLICATIONS 6,063,397 A 5/2000 Fowler ...... 424/443 6,096,326 A 8, 2000 Wikholm ...... 424/401 6,126,920 A 10/2000 Jones ...... 424/45 Natunola Castor 1023 Product Sheet; published Mar. 2010; down 6,132,746 A 10, 2000 Hasenoehrl. 424/403 loaded Feb. 9, 2012.* 6,228,351 B1 5, 2001 Viders ...... 424/64 Wayback showing of Dr. Dan's CortiBalm product description, dated 6,231,872 B1 5/2001 Mooney et al. 424/400 Dec. 31, 2009 and downloaded Sep. 2, 2013.* 6,251,425 B1 6/2001 Mathur ...... 424/450 Dr. Dan's CortiBalm product reviews dating May 2010 to present as 6,258,346 B1 7/2001 Scavone et al...... 424/65 shown at MakeupAlley.com; downloaded Sep. 2, 2013.* 6,342,208 B1 1/2002 Hyldgaard et al. ... 424,59 PediaDerm package insert dated Nov. 2, 2009; downloaded Sep. 2, 6,375,942 B1 4/2002 Rico ...... 424/78.07 2013.* 6,403,123 B1 6, 2002 Van Scott et al. ... 424/489 “International Search Report” for International Patent Application B1 11/2002 McCadden .... 424/401 6.479,058 No. PCT/US 11/01742 of Joel Schlessinger, MD, filed internationally 6,503.944 B1 1/2003 Chanchani . 514,506 on Oct. 12, 2011 (3 pages). 6,528,071 B2 3/2003 Vatter et al...... 424/401 “Written Opinion of the International Searching Authority” for Inter 6,558,680 B1 5, 2003 Riedel et al...... 424/401 6,613,338 B1 9, 2003 Schreiber ...... 424/401 national Patent Application No. PCT/US 11/01742 of Joel 6,753,013 B1 6, 2004 Didrekson etal 424/484 Schlessinger, MD, filed internationally on Oct. 12, 2011 (29 pages). 6,765,001 B2 7/2004 Gans ...... 514f172 Fancol (R) VB, Elementis Specialty, PDS-FancolVB pdf Mar. 2011 6,780,439 B2 8, 2004 Wilk .... 424,642 http://www.elementis.com/esweb/webproducts.nsfallibydecid/ 6,787,529 B2 9/2004 Hoy ...... 514,167 18F 2112739A91D158525776F004DDACA/SFILE/PDS 6,790,460 B2 9, 2004 Shefer et al. 424/489 FANCOL%C2%AE%20VB.pdf (2 pages). 6,830,758 B2 12/2004 Nichols ...... 424/443 Natunola (R) Castor 1023, www.natunola.com, Mar. 2010 (Identified 6,881,756 B2 4/2005 Gendimenico 514,732 on the above International Search Report) (1 page). 6,926,886 B2 8, 2005 Lin et al...... 424,59 Finsolv-TN, Innospec, www.innospec.com, Apr. 2010 (Identified on 6,964,782 B1 11/2005 Smith et all 424,616 the above International Search Report) (3 pages). 6,967,023 B1 1 1/2005 Eini et al...... 424/401 U.S. Appl. No. 12/925.464, filed Oct. 23, 2010, Joel Schlessinger et 6,979.454 B1 12/2005 Lindahl ...... 424/409 al. 7,109,246 B1 9, 2006 Hawtin .... 514,171 7,666,859 B2 2/2010 Turkowitz ...... 514,171 * cited by examiner U.S. Patent Apr. 1, 2014 Sheet 1 of 19 US 8,685,381 B2

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US 8,685,381 B2 1. 2 TOPCAL BASE AND ACTIVE In order to improve or promote a healing of the above (and AGENTCONTAINING COMPOSITIONS, AND other) types of skin problems in both human beings and METHODS FOR IMPROVING AND animals, it is often necessary, or at least desirable, to employ TREATING SKIN one or more topical compositions for a topical application to the skin that include one or more active agents in a base CROSS REFERENCE TO RELATED having an ability to act as a carrier vehicle for the active agents APPLICATIONS when topically applied to the skin, Such as a hydrocortisone containing ointment or cream for topical application to the This patent application is a continuation-in-part applica skin. However, very disadvantageously, many of the known tion of pending non-provisional patent application U.S. Ser. 10 topical skin compositions that contain hydrocortisone and/or No. 12/925,464, filed on Oct. 23, 2010. This continuation-in part patent application claims the benefit of priority to non other active agents do not penetrate the skin, or various layers provisional patent application U.S. Ser. No. 12/925,464, filed thereof, or tissues present therein, but in contrast, are only on Oct. 23, 2010, which patent application is hereby incor designed to lay on top of the skin stratum corneum (the porated into this continuation-in-part patent application in its 15 outermost layer of the epidermis, or external skin Surface). As entirety by reference herein, including all parts thereof. a result, these topical compositions often are not very effica cious, or at all efficacious, in repairing, improving or healing BACKGROUND OF THE INVENTION one or more skin disorders, diseases or adverse conditions, Such as an inflammation or redness that extends deep within 1. Field of the Invention the various layers of, and tissues present in, the skin. The present invention relates to novel topical base compo Moreover, Very disadvantageously, many of the base for sitions having a unique combination of ingredients, and mulations that are presently employed as carrier vehicles for weight percents thereof, for use as effective carrier vehicles topically applied active agents are very greasy and messy, for one or a plurality of active agents that are to be applied often soiling the clothing of the user, are not convenient for topically to the skin of a human being or animal. Such as 25 use by consumers and/or are Subject to deterioration under hydrocortisone, in active-agent containing compositions. one or more adverse environmental conditions (i.e., they dete The present invention also relates to novel active agent riorate). Such as high temperatures. For example, the base containing compositions, such as those that include hydro formulations that are employed in Some of the known and cortisone (alone or in a combination with one or more other commercially-available rigid stick formulations for a topical active ingredients), or one or more other active agents, for a 30 application to the skin and/or lips crack in relatively cold topical application to the skin of a human being or animal temperatures and/or melt in relatively high temperatures, having a unique combination of ingredients, and weight per causing the product to become less useful or completely cents thereof, which have been determined to have many useless, and often extremely messy and a waste of money. advantages in comparison with other topical active-agent Because many of these products include high quantities of containing compositions. For example, they penetrate one or 35 "oily' and/or “fatty' types of substances, if such substances more layers of, and tissues in, the skin, and have been deter melt under conditions of relatively high heat, such as when mined to be extremely efficacious in promoting a repair, an they are left in a glove box of a vehicle during hot summer improvement or a complete healing of a wide variety of months, the oils and/or fats, which generally are not soluble in different skin disorders, diseases and/or conditions, including water or in aqueous-based cleaning agents, can be extremely inflammation (acting as an anti-inflammatory agent), deep 40 difficult to remove from papers, clothing and similar types of within the layers and tissues of the skin, including the epider items, upon which they may melt and/or spill when melted. mis and epidermis. Moreover, most existing topical skin compositions have The present invention further relates to methods for pro either a very thick feel, lacking cosmetic elegance and there ducing the above formulations, and methods for improving, fore decreasing compliance, or a thin feel, which may repairing, healing or otherwise treating the skin of a mammal 45 increase compliance, but decreases efficacy greatly because with respect to a wide variety of different disorders, diseases an ability to decrease transepidermal water loss (TEWL) is and/or conditions, such as those that are described herein, very important for any of these medications, and is often and/or causing the mammal’s skin to feel soothed, softened lacking therefrom. and/or conditioned, by topically administering, or otherwise There are very few, if any, topical skin medications includ applying, effective amounts of the composition thereto. 50 ing hydrocortisone (and/or other active ingredients) on the 2. Background market that are present in a Solid form, such as a stick, allow The skin of mammals. Such as human beings and animals ing a user to treat an area of skin disease that is very Small, of all ages, and animals of all types, often becomes diseased, Such as a size of a pinpoint, or very large. Such as a plurality traumatized, inflamed, reddened, injured, irritated, damaged, of square inches in diameter, and effectively seal the skin off deteriorated, cracked, itchy, severely dried, covered with a 55 from further damage, all the while decreasing transepidermal plurality of bumps and/or blisters, acne and/or insect bites, or water loss (TEWL) and repairing or fully healing the skin. otherwise wounded as a result of a wide variety of causes. Additionally, those topical skin medications that include These causes include, but are not limited to, physical injury, hydrocortisone usually have an undesirable “tacky' feel to trauma, perforation, cutting, burning (by Sun exposure, flame, them, and have a very bitter taste and odor if applied to the hot objects and/or the like), blistering (from Sun exposure, 60 mucosal areas of the lips, which is also very undesirable, and other burning, shoes and/or the like), chapping, bites (by renders their efficacy less likely due to poor patient compli insects, animals, human beings and/or the like), disease or ance. To date, none of the existing hydrocortisone balm lip disorder (poison ivy, poison oak, genital disease and/or the formulations appear to have solved this problem of having a like), illness, microbes, exposure to chemicals, exposure to bitter taste. Additionally, none of these formulations have a harsh environmental conditions (extreme hot or cold condi 65 relatively solid consistency, leaving them unlikely to repair, tions, high winds, or the like), age, abuse, extreme dryness, improve or heal the skin of a patient for long periods of time, and/or other factors. as they come off of the skin easily. US 8,685,381 B2 3 4 Furthermore, none of the topical skin preparations includ under relatively extreme environmental conditions, such as at ing hydrocortisone in a stick formulation that are on the relatively low temperatures, for example, on a ski slope, and market have the directive of having one or two types of at relatively high temperatures, for example, in a hot vehicle methods and/or sizes to apply to either large or Small Surfaces during the Summer months; (X) is cosmetically elegant and of the skin. For this reason, they are severely limited when it physically appealing and desirable; (xi) promotes or other comes to the uses and applicability over various body Surface wise enhances patient compliance; and (xii) is relatively inex areas. For example, if one likens this to another process, if one pensive. only had one size of a paintbrush that was no larger than a It would also be extremely beneficial to provide base com toothbrush in size, the paintbrush would limit the uses of this positions that have the above characteristics, and can properly product. Interestingly, while hydrocortisone has been avail 10 function as carrier vehicles for one or more active agents to be able formany years, and otherformulations have attempted to applied topically to the skin of a human being or animal. apply it as a cream to the body, or even as an ointment, there have been no commercially-available products that combine Description of Related Art a palatable and elegantform of it in a lip-based product as well as in a product that is suitable for larger body surfaces. None 15 According to a Burt’s Bees lip balm Internet web site, of the existing formulations appear to have a large body Burt’s Bees lip balm, which is present in a tube, contains application methodology, as they only have a lip balm size. beeswax, Cocos nucifera (coconut) oil, helianthus annuus They are not indicated for the body, and there is no induce (Sunflower) seed oil, mentha piperita (peppermint) oil, lano ment on any packaging or promotional material for the finger lin, tocopherol, rosmarinus officinalis (rosemary) leaf extract, or hand cracks that occur in the drier times of the year or with glycine soia (soybean) oil, canola oil, Tin: cera alba (bees various skin diseases. wax, cire dabeille), prunus amygdalus dulcis (Sweet almond) Additionally, the topical skin products including hydrocor oil, mentha piperita (peppermint) oil, lanolin, tocopherol, tisone that have been marketed for over-the-counter treat rosmarinus officinalis (rosemary) leaf extract, glycine soia ments have typically been very limited as to treatment of (soybean) oil and canola oil (huile de colza). significant skin disease, as they have been creams or oint 25 According to a ChapStickR web site, ChapStickR) contains ments. These preparations typically have less penetration and seven natural ingredients that function as skin-conditioning less efficacy on adverse skin conditions, such as psoriasis and agents or moisturizers, which remain on the Surface of the eczema, and therefore, generally have little or no healing or skin. Some of these ingredients are also stated to prevent other effect on the skin of the majority of patients. As a result, evaporation of water and protect lips from drying and chap none of these existing hydrocortisone products have any indi 30 ping when exposed to wind or cold weather. The process of cation of usage for skin diseases other than chapped lips manufacturing ChapStickR) is stated to be similar to follow generally or chapped lips in patients with psoriasis or who are ing a recipe. A big blender is stated to mix the heated ingre taking Accutane or Soriatane (i.e., drugs that cause chapped dients of ChapStick R. The color and flavor are added, and lips), or related efficacy. then the warm mixture is poured into containers. In view of the above, it would be extremely beneficial to 35 Carmex is a brand of topical lip balm that is meant to provide, and treat the skin of mammals having one or a improve or eliminate cold Sores and soothe dry or chapped plurality of skin conditions, disorders, diseases and/or the lips. It may be sold in jars, sticks and Squeezable tubes. like, with a topical composition for application to the skin According to a Carmex Internet web site, traditional Carmex including one or more active agents, such as hydrocortisone, contains camphor, menthol, phenol, beeswax, cetyl esters, that: (i) penetrates one or a plurality of layers of the mam 40 flavor, fragrance, lanolin, paraffin, petrolatum, salicylic acid mal's skin, including the epidermis and dermis, and the tis and theobroma cacao(cocoa) seed butter. Sues therein, thereby exhibiting efficacious repair, complete According to a Blistex Internet web site, Blistex medicated healing and/or other beneficial actions in connection with a lip balm (in the form of a hard stick), contains the active variety of different skin problems, such as eczema, psoriasis, ingredients dimethicone (2.0%) (skin protectant), oxyben dermatitis, seborrheic dermatitis or severe dryness, deep 45 Zone (2.5%) (sunscreen) and padimate O (6.6%) (sunscreen), within the layers and/or tissues of the skin (rather than only as well as the other ingredients bees wax, camphor, cetyl resting on top of the outside of the outermost layer of the alcohol, cetyl Palmitate, euphorbia cerifera (candelilla) wax, mammal’s skin); (ii) has an ability to decrease or prevent flavors, isopropyl Myristate, isopropyl Palmitate, isopropyl transepidermal water loss (TEWL) from the skin and effec Stearate, lanolin, lanolin oil, menthol, methylparaben, min tively partially or fully seal the skin off from further environ 50 eral oil, oZokerite, paraffin, petrolatum, polybutene, propy mental and/or other damage; (iii) does not have an undesir lparaben, red 6 lake, theobroma cacao (cocoa) seed butter and able feel to the touch or skin of a mammal. Such as a very titanium dioxide. thick, very thin or tacky (sticky) feel, but rather has a rela U.S. Pat. No. 5,662.993 describes stick formulations for tively smooth, non-tacky, non-sticky and desirable feel; (iv) topical delivery of water soluble and/or water insoluble has a pleasant or desirable taste and odor to a user when 55 agents, which may contain steroids, antibiotics, antifungals, applied to mucosal areas of the lips (or elsewhere); (v) may be antihistamines anti inflammatories or local anesthetics. The formed into a wide variety of sizes and/or shapes, or in mul vehicles comprise a combination of waxes and oils and a tiple sizes and/or shapes, (vi) may be applied as a product over Surfactant in embodiments involving water Soluble agents. various different body surface areas of different sizes and/or U.S. Pat. No. 6,228.351 describes a lip balm for treating types, such as a lip-based product for application to the lips 60 cheilitis (painful dry inflamed lips) containing from 0.2% to and also as separate products that are Suitable for topical 2.5% hydrocortisone in a base of beeswax mineral oil and application to larger body Surfaces and, thus, permit a user to petroleum jelly, wherein the amount of petroleum jelly is not treat very Small and/or very large areas of the skin (such as a more than that of the beeswax and mineral oil combined, and pinpoint area and/or an area spanning one or a plurality of the amount of mineral oil is roughly equal to the amount of square inches or other shapes); (vii) is convenient and easy to 65 beeswax. In contrast with the compositions and base formu administer for users; (viii) is safe and reliable for use by lations of the present invention, the lip balms described by the mammals; (ix) maintains its consistency, form and shape 351 patent, which contain many different ingredients, and US 8,685,381 B2 5 6 weight percents thereof. Such as large quantities of petroleum or in multiple sizes and/or shapes, in a wide variety of differ jelly (from 40% to 50% by weight of the base), are used only ent containers, such as non-squeezable or squeezable tubes, upon the lips, and disadvantageously have an undesirable spray or non-spray cans, jars, pots, and the like: (vi) may be taste, which is typical of hydrocortisone-containing products applied as a product over various different body Surface areas (and tends to discourage, reduce or eliminate patient compli of different sizes and/or types, such as a lip-based product for ance). Further, as a result of its different ingredients, particu application to the lips, and also as separate products that are larly the large amount of petroleum jelly, these lip balms have Suitable for topical application to larger body Surfaces and, a very different consistency in comparison with the hydro thus, permit a user to treat very small and/or very large areas cortisone-containing (and other) compositions of the present of the skin (such as a pinpoint area and/or an area spanning invention. They have a liquid or semi-liquid type of a feel to 10 one or a plurality of square inches or other shapes); (vii) are the touch (i.e., not a solid feel), and may be messy and/or convenient and easy to administer for users; (viii) are safe and sloppy for use by individuals, and to their clothing, jewelry reliable for users; (ix) maintain their consistency, form and and Surrounding objects (papers, books, maps, Sunglasses, shape under relatively extreme environmental conditions, seat or car and/or the like), particularly when present at high Such as at relatively low temperatures, for example, on a ski temperatures. Further, these lip balms are not indicated by the 15 slope, and at relatively high temperatures, for example, in a 351 patent for any skin malady or condition other than pso hot vehicle during the Summer months; (X) are cosmetically riasis, and have not been shown by the 351 patent to be elegant and physically appealing and desirable; (xi) promote efficacious for any such malady or condition. or otherwise enhances or encourages patient or user compli Published U.S. Patent Application No. US 2004/0091539 ance; and/or (xii) are relatively inexpensive. Topical base and A1 describes a solid stick topical composition containing a active agent-containing compositions within the present corticosteroid, petrolatum, wax, propyleneglycol and an invention typically include each of the above benefits, and are emulsifier. improvements over known topical base and active agent Published U.S. Patent Application No. US 2003/0232091 containing compositions, including those containing hydro A1 describes a controlled release system for stabilizing ret cortisone. inol, retinol derivatives, and extracts containing retinol in 25 When employed in the manner, and under the conditions, cosmetic, dermatological, and pharmaceutical compositions. that are described herein, the base and active agent-contain Published U.S. Patent Application No. US 2004/0202725 ing compositions of the invention, which have specific for A1 describes compositions for the treatment of pilosebaceous mulations including a unique combination of ingredients, and gland inflammations, especially of the hair follicle and its weight percents thereof, have surprisingly and unexpectedly appendages, in particular of Acne Vulgaris and Folliculitis, 30 been determined via a significant amount of experimentation comprising as active ingredientaluminum fluoride, or chemi and testing on human beings to function extremely well cal compounds that finally release aluminum fluoride. together, providing topical skin compositions that are None of the patent documents or web sites that are identi extremely efficacious for: (i) repairing, improving, partially fied above describe or Suggest the unique base and active or fully healing, or otherwise treating a wide variety of agent-containing formulations of the present invention, or the 35 different skin disorders, diseases, conditions, maladies, dry related production or application methods, or compositions ness and/or the like, of the skin of mammals, such as inflam having the advantages that are described herein. mation, redness, itching, bumps, blisters, cuts, punctures, other wounds, cracking, severe dryness, allergic reactions, SUMMARY OF THE INVENTION insect bites, trauma, irritant dermatitis, contact dermatitis, 40 Seborrheic dermatitis, stasis dermatitis, perleche, psoriasis, It has been Surprisingly and unexpectedly determined after eczema, eczema craquele, acne excoriee (a form or irritated a significant amount of experimentation and testing on human and/or picked acne), allergies, other skin irritations, a variety beings that base and active-agent containing compositions of different skin complications resulting from acne, Xerosis, having the unique formulations that are described herein (i.e., disease related skin conditions and dryness from medica a particular combination of ingredients, and particular weight 45 tions, such as isotretinoin, acitretin, lipid-lowering agents percents thereof), when topically applied to the skin of a and/or the like; and/or (ii) causing the skin of a mammal to mammal, very advantageously: (i) penetrate one or a plurality feel less painful, less irritated, less itchy, softened, soothed of layers of the mammal’s skin, including the epidermis and and/or conditioned, often with a 100% improvement, as is dermis, and the tissues therein, thereby exhibiting efficacious described in the experiments that are described herein. The repair, complete healing and/or other beneficial actions in 50 hydrocortisone-containing skin balms of the present inven connection with a variety of different skin problems, such as tion have been significantly tested experimentally with eczema, psoriasis, dermatitis, Seborrheic dermatitis, cracks, human beings and determined to be very effective, for cuts, wounds, punctures, bumps, rashes, inflammation, severe example, on hand dermatitis, eczema, Seborrheic dermatitis, dryness and the like, deep within the layers and/or tissues of cracks, cuts, punctures and severe dryness from lip conditions the skin (rather than only resting on top of the outside of the 55 due to accutane usage, as is illustrated in the drawings outermost layer of the mammal’s skin); (ii) have an ability to included herein (FIGS. 2-17). decrease or prevent transepidermal water loss (TEWL) from The base and active agent-containing compositions of the the skin and effectively partially or fully seal the skin off from present invention exhibit benefits that are described above, further environmental and/or other damage; (iii) do not have and otherwise herein, generally to a significantly or far an undesirable feel to the touch or skin of a mammal. Such as 60 greater extent (for example, on a sale of from about 0% to a very thick, very thin or tacky (sticky) feel, but rather have a about 100%) in comparison with other base or active agent relatively smooth, non-tacky, non-sticky and desirable feel; containing compositions, and typically do not exhibit any of (iv) have a pleasant or desirable taste and odor to a user when the disadvantages that are discussed hereinabove in the Back applied to mucosal areas of the lips (or elsewhere), or have no. ground of Invention section. Many other Such compositions or a minimal, bitter or other undesirable taste and/or odor 65 do not exhibit one or more of the above advantages at all, or (whether including one or more flavoring ingredients or not); to any significant extent. Thus, the base and active agent (v) may be formed into a wide variety of sizes and/or shapes, containing compositions of the present invention are Superior US 8,685,381 B2 7 8 to, and a significant improvement of Such compositions and together a base composition in a sold or semi-solid form base formulations as a result of their numerous benefits and having an ability to function effectively as a topically-applied advantages, and a significant advance in this art. They have carrier vehicle for the active agents, and wherein the base advantages that overcome many or all of the shortcomings composition does not have a bitter taste or odor, has no dis that are described herein of other topical skin base and active tinctive taste or odor or has a pleasant taste or odor, or both agent containing compositions, and are able to repair, (even in the absence of any flavoring). improve and/or heal patients (or other users) having one or In yet another aspect, the present invention provides a more of the various adverse skin conditions, disorders or topical base composition in a Solid or semi-solid form for use diseases that are described herein, as well as many others. as a carrier vehicle for one or a plurality of active agents. Such The base and active agent-containing compositions of the 10 as hydrocortisone, consisting of (or consisting essentially of) invention are very different from any existing topical lip or skin balm (or other composition) because they include a FANCOLVB, Natunola Castor 1023, Finsolv TN, bees wax, unique combination of the ingredients Finsolv TN, Natunola one or a plurality of plant or plant seed oils, one or a plurality Castor 1023, FANCOL VB and bees wax, as well as one or of fatty alcohols, one or a plurality of fats, and one or a more optional ingredients, which together produce a prefer 15 plurality of flavorings, each in combined amounts that are ably solid, firm, yet pliable, balm that has an ability to main effective for collectively forming togethera base composition tain its consistency, form and shape over time, and reduces, in a sold or semi-solid form having an ability to function masks or eliminates the taste(s) and odor(s) of otherwise effectively as a topically-applied carrier vehicle for the active undesirably tasting ingredients, for example, the undesirable agents, and wherein the base composition does not have a bitter taste of hydrocortisone. bitter taste or odor, has no distinctive taste or odor or has a Base pleasant taste or odor, or both (even in the absence of any In one aspect, the present invention provides a topical base flavoring). composition in a solid or semi-solid form for use as a carrier vehicle for one or a plurality of active agents, such as hydro Original (Specific) Formulations cortisone, comprising FANCOL VB, Natunola Castor 1023, 25 Finsolv TN and bees wax, each in amounts that are effective In another aspect, the present invention provides a topical for collectively forming together a base composition in a sold base composition in a solid or semi-solid form for use as a or semi-solid form having an ability to function effectively as carrier vehicle for one or a plurality of active agents, such as a topically-applied carrier vehicle for the active agents. hydrocortisone, comprising: In another aspect, the present invention provides a topical 30 (a) FANCOLVB, wherein the FANCOLVB is present in base composition in a solid or semi-solid form for use as a the base composition in an amount ranging from about 9 carrier vehicle for one or a plurality of active agents, such as to about 25 weight percent; hydrocortisone, consisting of (or consisting essentially of) (b) Natunola Castor 1023, wherein the Natunola Castor FANCOL VB, Natunola Castor 1023, Finsolv TN and bees 1023 is present in the base composition in an amount wax, each in amounts that are effective for collectively form 35 ing together a base composition in a sold or semi-solid form ranging from about 16 to about 39 weight percent; having an ability to function effectively as a topically-applied (c) Finsolv TN, wherein the Finsolv TN is present in the carrier vehicle for the active agents. base composition in an amount ranging from about 9 to In another aspect, the present invention provides a topical about 25 weight percent; base composition in a solid or semi-solid form for use as a 40 (d) bees wax, wherein the bees wax is present in the base carrier vehicle for one or a plurality of active agents. Such as composition in an amount ranging from about 18 to hydrocortisone, comprising FANCOL VB, Natunola Castor about 43 weight percent; 1023, Finsolv TN, bees wax, one or a plurality of plant or (e) optionally, one or a plurality of plant oils or plant seed plant seed oils, one or a plurality of fatty alcohols, and one or oils, wherein the plant or plant seed oils are present in the a plurality offats, eachin combined amounts that are effective 45 base composition in a combined amount ranging from for collectively forming together a base composition in a sold about 0 to about 24 weight percent; or semi-solid form having an ability to function effectively as (f) optionally, one or a plurality of fatty alcohols, wherein a topically-applied carrier vehicle for the active agents. the fatty alcohols are present in the base composition in In still another aspect, the present invention provides a a combined amount ranging from about 0 to about 22 topical base composition in a Solid or semi-solid form for use 50 weight percent; as a carrier vehicle for one or a plurality of active agents. Such (g) optionally, one or a plurality of fats, wherein the fats are as hydrocortisone, consisting of (or consisting essentially of) present in the base composition in a combined amount FANCOLVB, Natunola Castor 1023, Finsolv TN, bees wax, ranging from about 0 to about 9 weight percent; and one or a plurality of plant or plant seed oils, one or a plurality (h) optionally, one or a plurality of flavorings, wherein the of fatty alcohols, and one or a plurality of fats, each in com 55 flavorings are present in the base composition in a com bined amounts that are effective for collectively forming bined amount ranging from about 0 to about 3.5 weight together a base composition in a sold or semi-solid form percent; having an ability to function effectively as a topically-applied wherein the base composition is in a sold or semi-solid form carrier vehicle for the active agents. having an ability to function effectively as a topically-applied In another aspect, the present invention provides a topical 60 carrier vehicle for the active agents. base composition in a solid or semi-solid form for use as a In still another aspect, the present invention provides a carrier vehicle for one or a plurality of active agents. Such as topical base composition in a Solid or semi-solid form for use hydrocortisone, comprising FANCOL VB, Natunola Castor as a carrier vehicle for one or a plurality of active agents. Such 1023, Finsolv TN, bees wax, one or a plurality of plant or as hydrocortisone, consisting of (or consisting essentially of): plant seed oils, one or a plurality of fatty alcohols, one or a 65 (a) FANCOLVB, wherein the FANCOLVB is present in plurality of fats, and one or a plurality of flavorings, each in the base composition in an amount ranging from about 9 combined amounts that are effective for collectively forming to about 25 weight percent; US 8,685,381 B2 9 10 (b) Natunola Castor 1023, wherein the Natunola Castor (a) FANCOLVB, wherein the FANCOLVB is present in 1023 is present in the base composition in an amount the base composition in an amount ranging from about 9 ranging from about 16 to about 39 weight percent; to about 13 weight percent; (c) Finsolv TN, wherein the Finsolv TN is present in the (b) Natunola Castor 1023, wherein the Natunola Castor base composition in an amount ranging from about 9 to 1023 is present in the base composition in an amount about 25 weight percent; ranging from about 16 to about 20 weight percent; (d) bees wax, wherein the bees wax is present in the base (c) Finsolv TN, wherein the Finsolv TN is present in the composition in an amount ranging from about 18 to base composition in an amount ranging from about 9 to about 43 weight percent; about 13 weight percent; (e) optionally, one or a plurality of plant oils or plant seed 10 (d) bees wax, wherein the bees wax is present in the base oils, wherein the plant or plant seed oils are present in the composition in an amount ranging from about 18 to base composition in a combined amount ranging from about 22 weight percent; about 0 to about 24 weight percent; (e) one or more plant or plant seed oils, wherein the plant or (f) optionally, one or a plurality of fatty alcohols, wherein 15 plant seed oils are present in the base composition in a the fatty alcohols are present in the base composition in combined amount ranging from about 0.1 to about 24 a combined amount ranging from about 0 to about 22 weight percent; weight percent; (f) one or more fatty alcohols, wherein the fatty alcohols (g) optionally, one or a plurality of fats, wherein the fats are are present in the base composition in a combined present in the base composition in a combined amount amount ranging from about 0.1 to about 22 weight per ranging from about 0 to about 9 weight percent; and cent; (h) optionally, one or a plurality of flavorings, wherein the (g) one or more fats, wherein the fats are present in the base flavorings are present in the base composition in a com composition in a combined amount ranging from about bined amount ranging from about 0 to about 3.5 weight 0.1 to about 9 weight percent; and percent; 25 (h) optionally, one or a plurality of flavorings, wherein the wherein the base composition is in a sold or semi-solid form flavorings are present in the base composition in an having an ability to function effectively as a topically-applied amount ranging from about 0 to about 3.5 weight per carrier vehicle for the active agents. cent; In another aspect, the present invention provides a topical wherein the base composition is in a sold or semi-solid form base composition in a solid or semi-solid form for use as a 30 having an ability to function effectively as a topically-applied carrier vehicle for one or a plurality of active agents, such as carrier vehicle for the active agents. hydrocortisone, comprising: (a) FANCOL VB, wherein the FANCOLVB is present in Subsequent (Improved) Formulations the base composition in an amount ranging from about 9 to about 13 weight percent; 35 In another aspect, the present invention provides a topical (b) Natunola Castor 1023, wherein the Natunola Castor base composition in a solid or semi-solid form for use as a 1023 is present in the base composition in an amount carrier vehicle for one or a plurality of active agents, such as ranging from about 16 to about 20 weight percent; hydrocortisone, comprising: (c) Finsolv TN, wherein the Finsolv TN is present in the 40 (a) FANCOLVB, wherein the FANCOLVB is present in base composition in an amount ranging from about 9 to the base composition in an amount ranging from about 6 about 13 weight percent; to about 25 weight percent; (d) bees wax, wherein the bees wax is present in the base (b) Natunola Castor 1023, wherein the Natunola Castor composition in an amount ranging from about 18 to 1023 is present in the base composition in an amount about 22 weight percent; 45 ranging from about 5 to about 39 weight percent; (e) one or more plant or plant seed oils, wherein the plant or (c) Finsolv TN, wherein the Finsolv TN is present in the plant seed oils are present in the base composition in a base composition in an amount ranging from about 9 to combined amount ranging from about 0.1 to about 24 about 25 weight percent; weight percent; (d) bees wax, wherein the bees wax is present in the base (f) one or more fatty alcohols, wherein the fatty alcohols 50 composition in an amount ranging from about 6 to about are present in the base composition in a combined 43 weight percent; amount ranging from about 0.1 to about 22 weight per (e) optionally, one or a plurality of plant oils or plant seed cent; oils, wherein the plant or plant seed oils are present in the (g) one or more fats, wherein the fats are present in the base base composition in a combined amount ranging from composition in a combined amount ranging from about 55 about 0 to about 38.5 (38.0 if one or more flavoring 0.1 to about 9 weight percent; and ingredients are present) weight percent; (h) optionally, one or a plurality of flavorings, wherein the (f) optionally, one or a plurality of fatty alcohols, wherein flavorings are present in the base composition in an the fatty alcohols are present in the base composition in amount ranging from about 0 to about 3.5 weight per a combined amount ranging from about 0 to about 25 cent; 60 weight percent; wherein the base composition is in a sold or semi-solid form (g) optionally, one or a plurality of fats, wherein the fats are having an ability to function effectively as a topically-applied present in the base composition in a combined amount carrier vehicle for the active agents. ranging from about 0 to about 12 weight percent; and In still another aspect, the present invention provides a (h) optionally, one or a plurality of flavorings, wherein the topical base composition in a Solid or semi-solid form for use 65 flavorings are present in the base composition in a com as a carrier vehicle for one or a plurality of active agents. Such bined amount ranging from about 0 to about 3.5 weight as hydrocortisone, consisting of (or consisting essentially of): percent; US 8,685,381 B2 11 12 wherein the base composition is in a sold or semi-solid form (g) one or a plurality of fats, wherein the fats are present in having an ability to function effectively as a topically-applied the base composition in a combined amount ranging carrier vehicle for the active agents. from about 2 to about 12 weight percent; In still another aspect, the present invention provides a wherein the base composition is in a sold or semi-solid form topical base composition in a Solid or semi-solid form for use having an ability to function effectively as a topically-applied as a carrier vehicle for one or a plurality of active agents. Such carrier vehicle for the active agents. as hydrocortisone, consisting of (or consisting essentially of): In still another aspect, the present invention provides a (a) FANCOL VB, wherein the FANCOLVB is present in topical base composition in a Solid or semi-solid form for use the base composition in an amount ranging from about 6 as a carrier vehicle for one or a plurality of active agents. Such to about 25 weight percent; 10 as hydrocortisone, consisting of (or consisting essentially of): (b) Natunola Castor 1023, wherein the Natunola Castor (a) FANCOLVB, wherein the FANCOLVB is present in 1023 is present in the base composition in an amount the base composition in an amount ranging from about 6 ranging from about 5 to about 39 weight percent; to about 16 weight percent; (c) Finsolv TN, wherein the Finsolv TN is present in the 15 (b) Natunola Castor 1023, wherein the Natunola Castor base composition in an amount ranging from about 9 to 1023 is present in the base composition in an amount about 25 weight percent; ranging from about 5 to about 15 weight percent; (d) bees wax, wherein the bees wax is present in the base (c) Finsolv TN, wherein the Finsolv TN is present in the composition in an amount ranging from about 6 to about base composition in an amount ranging from about 10 to 43 weight percent; about 20 weight percent; (e) optionally, one or a plurality of plant oils or plant seed (d) bees wax, wherein the bees wax is present in the base oils, wherein the plant or plant seed oils are present in the composition in an amount ranging from about 6 to about base composition in a combined amount ranging from 16 weight percent; about 0 to about 38.5 (38.0 if one or more flavoring (e) one or a plurality of plant oils or plant seed oils, wherein ingredients are present) weight percent; 25 the plant or plant seed oils are present in the base com (f) optionally, one or a plurality of fatty alcohols, wherein position in a combined amount ranging from about 13.5 the fatty alcohols are present in the base composition in to about 38.5 weight percent; a combined amount ranging from about 0 to about 25 (f) one or a plurality of fatty alcohols, wherein the fatty weight percent; alcohols are present in the base composition in a com (g) optionally, one or a plurality of fats, wherein the fats are 30 present in the base composition in a combined amount bined amount ranging from about 15 to about 25 weight ranging from about 0 to about 12 weight percent; and percent; and (h) optionally, one or a plurality of flavorings, wherein the (g) one or a plurality of fats, wherein the fats are present in flavorings are present in the base composition in a com the base composition in a combined amount ranging bined amount ranging from about 0 to about 3.5 weight 35 from about 2 to about 12 weight percent; percent; wherein the base composition is in a sold or semi-solid form wherein the base composition is in a sold or semi-solid form having an ability to function effectively as a topically-applied having an ability to function effectively as a topically-applied carrier vehicle for the active agents. carrier vehicle for the active agents. Flavored Base Compositions (Non-OTC, but Including Preferred subsequent (improved) base compositions of the 40 Flavoring Ingredient(s)) invention include those that are described below. In another aspect, the present invention provides a topical Non-Flavored Base Compositions (Non-OTC and No Fla base composition in a solid or semi-solid form for use as a Voring Ingredients) carrier vehicle for one or a plurality of active agents, such as In another aspect, the present invention provides a topical hydrocortisone, comprising: base composition in a solid or semi-solid form for use as a 45 (a) FANCOLVB, wherein the FANCOLVB is present in carrier vehicle for one or a plurality of active agents. Such as the base composition in an amount ranging from about 6 hydrocortisone, comprising: to about 16 weight percent; (a) FANCOL VB, wherein the FANCOLVB is present in (b) Natunola Castor 1023, wherein the Natunola Castor the base composition in an amount ranging from about 6 1023 is present in the base composition in an amount to about 16 weight percent; 50 ranging from about 5 to about 15 weight percent; (b) Natunola Castor 1023, wherein the Natunola Castor (c) Finsolv TN, wherein the Finsolv TN is present in the 1023 is present in the base composition in an amount base composition in an amount ranging from about 10 to ranging from about 5 to about 15 weight percent; about 20 weight percent; (c) Finsolv TN, wherein the Finsolv TN is present in the (d) bees wax, wherein the bees wax is present in the base base composition in an amount ranging from about 10 to 55 composition in an amount ranging from about 6 to about about 20 weight percent; 16 weight percent; (d) bees wax, wherein the bees wax is present in the base (e) one or a plurality of plant oils or plant seed oils, wherein composition in an amount ranging from about 6 to about the plant or plant seed oils are present in the base com 16 weight percent; position in a combined amount ranging from about 13.0 (e) one or a plurality of plant oils or plant seed oils, wherein 60 to about 38.0 weight percent; the plant or plant seed oils are present in the base com (f) one or a plurality of fatty alcohols, wherein the fatty position in a combined amount ranging from about 13.5 alcohols are present in the base composition in a com to about 38.5 weight percent; bined amount ranging from about 15 to about 25 weight (f) one or a plurality of fatty alcohols, wherein the fatty percent; alcohols are present in the base composition in a com 65 (g) one or a plurality of fats, wherein the fats are present in bined amount ranging from about 15 to about 25 weight the base composition in a combined amount ranging percent; and from about 2 to about 12 weight percent; and US 8,685,381 B2 13 14 (h) one or a plurality of flavorings, wherein the flavorings In yet another aspect, the present invention provides a are present in the base composition in a combined composition for topical application to the skin of a mammal amount ranging from about 0.1 to about 2.5 weight for repairing, improving or fully healing a skin disorder, percent; disease or condition, or for causing the mammal’s skin to wherein the base composition is in a sold or semi-solid form experience a reduction in pain, Soreness or itchiness, or an having an ability to function effectively as a topically-applied increase in soothing, softening or conditioning, or a combi carrier vehicle for the active agents. nation thereof, consisting of (or consisting essentially of): In another aspect, the present invention provides a topical (a) one or a plurality of active agents, such as hydrocorti base composition in a solid or semi-solid form for use as a Sone, wherein the active agents are present in the com carrier vehicle for one or a plurality of active agents. Such as 10 hydrocortisone, consisting of (or consisting essentially of): position in a combined amount that is effective for (a) FANCOL VB, wherein the FANCOLVB is present in repairing, improving or healing the mammal’s skin, or the base composition in an amount ranging from about 6 causing the mammal’s skin to experience a reduction in to about 16 weight percent; pain, Soreness or itchiness, or an increase in Soothing, (b) Natunola Castor 1023, wherein the Natunola Castor 15 Softening or conditioning, or a combination thereof. 1023 is present in the base composition in an amount after a topical application of the composition to the ranging from about 5 to about 15 weight percent; mammal’s skin; and (c) Finsolv TN, wherein the Finsolv TN is present in the (b) a base composition, wherein the base composition is base composition in an amount ranging from about 10 to present in the composition in an amount that is effective about 20 weight percent; for permitting the base composition to function effec (d) bees wax, wherein the bees wax is present in the base tively as a carrier vehicle for the active agents when composition in an amount ranging from about 6 to about topically applied to the mammal’s skin, and wherein the 16 weight percent; base composition includes FANCOLVB, Natunola Cas (e) one or a plurality of plant oils or plant seed oils, wherein tor 1023, Finsolv TN and beeswax, eachinamounts that the plant or plant seed oils are present in the base com 25 are effective for collectively forming together the base position in a combined amount ranging from about 13.0 composition in a sold or semi-solid form. to about 38.0 weight percent; In another aspect, the present invention provides a compo (f) one or a plurality of fatty alcohols, wherein the fatty sition for topical application to the skin of a mammal for alcohols are present in the base composition in a com repairing, improving or fully healing a skin disorder, disease bined amount ranging from about 15 to about 25 weight 30 percent; or condition, or for causing the mammal’s skin to experience (g) one or a plurality of fats, wherein the fats are present in a reduction in pain, Soreness or itchiness, or an increase in the base composition in a combined amount ranging Soothing, softening or conditioning, or a combination thereof, from about 2 to about 12 weight percent; and comprising: (h) one or a plurality of flavorings, wherein the flavorings 35 (a) one or a plurality of active agents, such as hydrocorti are present in the base composition in a combined Sone, wherein the active agents are present in the com amount ranging from about 0.1 to about 2.5 weight position in a combined amount that is effective for percent; repairing, improving or healing the mammal’s skin, or wherein the base composition is in a sold or semi-solid form causing the mammal’s skin to experience a reduction in having an ability to function effectively as a topically-applied 40 pain, Soreness or itchiness, or an increase in Soothing, carrier vehicle for the active agents. Softening or conditioning, or a combination thereof. Active Agent Containing Composition after a topical application of the composition to the In another aspect, the present invention provides a compo mammal’s skin; and sition for topical application to the skin of a mammal for (b) a base composition, wherein the base composition is repairing, improving or fully healing a skin disorder, disease 45 present in the composition in an amount that is effective or condition, or for causing the mammal’s skin to experience for permitting the base composition to function effec a reduction in pain, Soreness or itchiness, or an increase in tively as a carrier vehicle for the active agents when Soothing, softening or conditioning, or a combination thereof, topically applied to the mammal’s skin, and wherein the comprising: base composition includes FANCOLVB, Natunola Cas (a) one or a plurality of active agents, such as hydrocorti 50 tor 1023, Finsolv TN, bees wax, one or a plurality of Sone, wherein the active agents are present in the com plant or plant seed oils, one or a plurality of fatty alco position in a combined amount that is effective for hols, and one or a plurality of fats, each in combined repairing, improving or healing the mammal’s skin, or amounts that are effective for collectively forming causing the mammal’s skin to experience a reduction in together a base composition in a sold or semi-solid form. pain, Soreness or itchiness, or an increase in soothing, 55 In still another aspect, the present invention provides a Softening or conditioning, or a combination thereof. composition for topical application to the skin of a mammal after a topical application of the composition to the for repairing, improving or fully healing a skin disorder, mammal’s skin; and disease or condition, or for causing the mammal’s skin to (b) a base composition, wherein the base composition is experience a reduction in pain, Soreness or itchiness, or an present in the composition in an amount that is effective 60 increase in soothing, softening or conditioning, or a combi for permitting the base composition to function effec nation thereof, consisting of (or consisting essentially of): tively as a carrier vehicle for the active agents when (a) one or a plurality of active agents, such as hydrocorti topically applied to the mammal’s skin, and wherein the Sone, wherein the active agents are present in the com base composition includes FANCOLVB, Natunola Cas position in a combined amount that is effective for tor 1023, Finsolv TN and beeswax, eachinamounts that 65 repairing, improving or healing the mammal’s skin, or are effective for collectively forming together the base causing the mammal’s skin to experience a reduction in composition in a sold or semi-solid form. pain, Soreness or itchiness, or an increase in Soothing, US 8,685,381 B2 15 16 Softening or conditioning, or a combination thereof. plant or plant seed oils, one or a plurality of fatty alco after a topical application of the composition to the hols, one or a plurality of fats, and one or a plurality of mammal’s skin; and flavorings, each in combined amounts that are effective (b) a base composition, wherein the base composition is for collectively forming togetherabase composition in a present in the composition in an amount that is effective sold or semi-solid form, and wherein the base composi for permitting the base composition to function effec tion does not have a bitter taste or odor, has no distinctive tively as a carrier vehicle for the active agents when taste or odor or has a pleasant taste or odor, or both. topically applied to the mammal’s skin, and wherein the base composition includes FANCOLVB, Natunola Cas Original (Specific) Formulations tor 1023, Finsolv TN, bees wax, one or a plurality of 10 plant or plant seed oils, one or a plurality of fatty alco In another aspect, the present invention provides a compo hols, and one or a plurality of fats, each in combined sition for topical application to the skin of a mammal for amounts that are effective for collectively forming repairing, improving or fully healing a skin disorder, disease together a base composition in a sold or semi-solid form. or condition, or for causing the mammal’s skin to experience In another aspect, the present invention provides a compo 15 sition for topical application to the skin of a mammal for a reduction in pain, Soreness or itchiness, or an increase in repairing, improving or fully healing a skin disorder, disease Soothing, softening or conditioning, or a combination thereof, or condition, or for causing the mammal’s skin to experience comprising: a reduction in pain, Soreness or itchiness, or an increase in (a) one or a plurality of active agents, such as hydrocorti Soothing, softening or conditioning, or a combination thereof, Sone, wherein the active agents are present in the com comprising: position in a combined amount ranging from about 0.1 to (a) one or a plurality of active agents, such as hydrocorti about 5 weight percent; and Sone, wherein the active agents are present in the com (b) a base composition, wherein the base composition is position in a combined amount that is effective for present in the composition in an amount ranging from repairing, improving or healing the mammal’s skin, or 25 about 95 to about 99.9 weight percent, and wherein the causing the mammal’s skin to experience a reduction in base composition includes: pain, Soreness or itchiness, or an increase in soothing, (1) FANCOL VB, wherein the FANCOL VB is present Softening or conditioning, or a combination thereof. in the base composition in an amount ranging from after a topical application of the composition to the about 9 to about 25 weight percent; mammal’s skin; and 30 (2) Natunola Castor 1023, wherein the Natunola Castor (b) a base composition, wherein the base composition is 1023 is present in the base composition in an amount present in the composition in an amount that is effective ranging from about 16 to about 39 weight percent; for permitting the base composition to function effec (3) Finsolv TN, wherein the Finsolv TN is present in the tively as a carrier vehicle for the active agents when base composition in an amount ranging from about 9 topically applied to the mammal’s skin, and wherein the 35 base composition includes FANCOLVB, Natunola Cas to about 25 weight percent; tor 1023, Finsolv TN, bees wax, one or a plurality of (4) beeswax, wherein the beeswax is present in the base plant or plant seed oils, one or a plurality of fatty alco composition in an amount ranging from about 18 to hols, one or a plurality of fats, and one or a plurality of about 43 weight percent; flavorings, each in combined amounts that are effective 40 (5) optionally, one or a plurality of plant oils or plant for collectively forming togetherabase composition in a seed oils, wherein the plant or plant seed oils are sold or semi-solid form, and wherein the base composi present in the base compositionina combined amount tion does not have a bitter taste or odor, has no distinctive ranging from about 0 to about 24 weight percent; taste or odor or has a pleasant taste or odor, or both. (6) optionally, one or a plurality of fatty alcohols, In yet aspect, the present invention provides a composition 45 wherein the fatty alcohols are present in the base for topical application to the skin of a mammal for repairing, composition in a combined amount ranging from improving or fully healing a skin disorder, disease or condi about 0 to about 22 weight percent; tion, or for causing the mammal’s skin to experience a reduc (7) optionally, one or a plurality of fats, wherein the fats tion in pain, Soreness or itchiness, or an increase in soothing, are present in the base composition in a combined softening or conditioning, or a combination thereof, consist 50 amount ranging from about 0 to about 9 weight per ing of (or consisting essentially of): cent; and (a) one or a plurality of active agents, such as hydrocorti (8) optionally, one or a plurality of flavorings, wherein Sone, wherein the active agents are present in the com the flavorings are present in the base composition in a position in a combined amount that is effective for combined amount ranging from about 0 to about 3.5 repairing, improving or healing the mammal’s skin, or 55 weight percent; causing the mammal’s skin to experience a reduction in wherein the composition is in a sold or semi-solid form. pain, Soreness or itchiness, or an increase in soothing, In still another aspect, the present invention provides a Softening or conditioning, or a combination thereof. composition for topical application to the skin of a mammal after a topical application of the composition to the for repairing, improving or fully healing a skin disorder, mammal’s skin; and 60 disease or condition, or for causing the mammal’s skin to (b) a base composition, wherein the base composition is experience a reduction in pain, Soreness or itchiness, or an present in the composition in an amount that is effective increase in soothing, softening or conditioning, or a combi for permitting the base composition to function effec nation thereof, consisting of (or consisting essentially of): tively as a carrier vehicle for the active agents when (a) one or a plurality of active agents, such as hydrocorti topically applied to the mammal’s skin, and wherein the 65 Sone, wherein the active agents are present in the com base composition includes FANCOLVB, Natunola Cas position in a combined amount ranging from about 0.1 to tor 1023, Finsolv TN, bees wax, one or a plurality of about 5 weight percent; and US 8,685,381 B2 17 18 (b) a base composition, wherein the base composition is (6) one or more fatty alcohols, wherein the fatty alcohols present in the composition in an amount ranging from are present in the base composition in a combined about 95 to about 99.9 weight percent, and wherein the amount ranging from about 0.1 to about 22 weight base composition includes: percent; (1) FANCOL VB, wherein the FANCOL VB is present 5 (7) one or more fats, wherein the fats are present in the in the base composition in an amount ranging from base composition in a combined amount ranging from about 9 to about 25 weight percent; about 0.1 to about 9 weight percent; and (2) Natunola Castor 1023, wherein the Natunola Castor (8) optionally, one or a plurality of flavorings, wherein 1023 is present in the base composition in an amount the flavorings are present in the base composition in ranging from about 16 to about 39 weight percent; 10 an amount ranging from about 0 to about 3.5 weight (3) Finsolv TN, wherein the Finsolv TN is present in the percent; base composition in an amount ranging from about 9 wherein the composition is in a sold or semi-solid form. to about 25 weight percent; In another aspect, the present invention provides a compo (4) beeswax, wherein the beeswax is present in the base 15 sition for topical application to the skin of a mammal for composition in an amount ranging from about 18 to repairing, improving or fully healing a skin disorder, disease about 43 weight percent; or condition, or for causing the mammal’s skin to experience (5) optionally, one or a plurality of plant oils or plant a reduction in pain, Soreness or itchiness, or an increase in seed oils, wherein the plant or plant seed oils are Soothing, softening or conditioning, or a combination thereof, present in the base compositionina combined amount consisting of (or consisting essentially of): ranging from about 0 to about 24 weight percent; (a) one or a plurality of active agents, such as hydrocorti (6) optionally, one or a plurality of fatty alcohols, Sone, wherein the active agents are present in the com wherein the fatty alcohols are present in the base position in a combined amount ranging from about 0.1 to composition in a combined amount ranging from about 5 weight percent; and about 0 to about 22 weight percent; 25 (b) a base composition, wherein the base composition is (7) optionally, one or a plurality of fats, wherein the fats present in the composition in an amount ranging from are present in the base composition in a combined about 95 to about 99.9 weight percent, and wherein the amount ranging from about 0 to about 9 weight per base composition includes: cent; and (1) FANCOL VB, wherein the FANCOL VB is present (8) optionally, one or a plurality of flavorings, wherein 30 in the base composition in an amount ranging from the flavorings are present in the base composition in a about 9 to about 13 weight percent; combined amount ranging from about 0 to about 3.5 (2) Natunola Castor 1023, wherein the Natunola Castor weight percent; 1023 is present in the base composition in an amount wherein the composition is in a sold or semi-solid form. 35 ranging from about 16 to about 20 weight percent; In another aspect, the present invention provides a compo (3) Finsolv TN, wherein the Finsolv TN is present in the sition for topical application to the skin of a mammal for base composition in an amount ranging from about 9 repairing, improving or fully healing a skin disorder, disease to about 13 weight percent; or condition, or for causing the mammal’s skin to experience (4) beeswax, wherein the beeswax is present in the base a reduction in pain, Soreness or itchiness, or an increase in 40 composition in an amount ranging from about 18 to Soothing, softening or conditioning, or a combination thereof, about 22 weight percent; comprising: (5) one or more plant or plant seed oils, wherein the plant (a) one or a plurality of active agents, such as hydrocorti or plant seed oils are present in the base composition Sone, wherein the active agents are present in the com in a combined amount ranging from about 0.1 to about positionina combined amount ranging from about 0.1 to 45 24 weight percent; about 5 weight percent; and (6) one or more fatty alcohols, wherein the fatty alcohols (b) a base composition, wherein the base composition is are present in the base composition in a combined present in the composition in an amount ranging from amount ranging from about 0.1 to about 22 weight about 95 to about 99.9 weight percent, and wherein the percent; base composition includes: 50 (7) one or more fats, wherein the fats are present in the (1) FANCOL VB, wherein the FANCOL VB is present base composition in a combined amount ranging from about 0.1 to about 9 weight percent; and in the base composition in an amount ranging from (8) optionally, one or a plurality of flavorings, wherein about 9 to about 13 weight percent; the flavorings are present in the base composition in (2) Natunola Castor 1023, wherein the Natunola Castor 55 an amount ranging from about 0 to about 3.5 weight 1023 is present in the base composition in an amount percent; ranging from about 16 to about 20 weight percent; wherein the composition is in a sold or semi-solid form. (3) Finsolv TN, wherein the Finsolv TN is present in the base composition in an amount ranging from about 9 Subsequent (Improved) Formulations to about 13 weight percent; 60 (4) beeswax, wherein the beeswax is present in the base In another aspect, the present invention provides a compo composition in an amount ranging from about 18 to sition for topical application to the skin of a mammal for about 22 weight percent; repairing, improving or fully healing a skin disorder, disease (5) one or more plant or plant seed oils, wherein the plant or condition, or for causing the mammal’s skin to experience or plant seed oils are present in the base composition 65 a reduction in pain, Soreness or itchiness, or an increase in in a combined amount ranging from about 0.1 to about Soothing, softening or conditioning, or a combination thereof, 24 weight percent; comprising: US 8,685,381 B2 19 20 (a) one or a plurality of active agents, such as hydrocorti (g) one or a plurality of fatty alcohols, wherein the fatty Sone, wherein the active agents are present in the com alcohols are present in the composition in a combined positionina combined amount ranging from about 0.1 to amount ranging from about 15 to about 25 weight per about 5 weight percent; cent; and (b) FANCOLVB, wherein the FANCOLVB is present in 5 (h) one or a plurality of fats, wherein the fats are present in the composition in an amount ranging from about 6 to the composition in a combined amount ranging from about 25 weight percent; about 2 to about 12 weight percent; (c) Natunola Castor 1023, wherein the Natunola Castor wherein the composition is in a sold or semi-solid form. 1023 is present in the composition in an amount ranging In still another aspect, the present invention provides a from about 5 to about 39 weight percent; 10 composition for topical application to the skin of a mammal (d) Finsolv TN, wherein the Finsolv TN is present in the for repairing, improving or fully healing a skin disorder, composition in an amount ranging from about 9 to about disease or condition, or for causing the mammal’s skin to 25 weight percent; experience a reduction in pain, Soreness or itchiness, or an (e) bees wax, wherein the bees wax is present in the com 15 increase in soothing, softening or conditioning, or a combi position in an amount ranging from about 6 to about 43 nation thereof, consisting of (or consisting essentially of): weight percent; (a) one or a plurality of active agents, such as hydrocorti (f) optionally, one or a plurality of plant oils or plant seed Sone, wherein the active agents are present in the com oils, wherein the plant or plant seed oils are present in the position in a combined amount ranging from about 0.1 to composition in a combined amount ranging from about about 3 weight percent; 0 to about 37.0 (37.5 if no flavoring ingredient is present) (b) FANCOLVB, wherein the FANCOL VB is present in weight percent; the composition in an amount ranging from about 6 to (g) optionally, one or a plurality of fatty alcohols, wherein about 16 weight percent; the fatty alcohols are present in the composition in a (c) Natunola Castor 1023, wherein the Natunola Castor combined amount ranging from about 0 to about 25 25 1023 is present in the composition in an amount ranging weight percent; from about 5 to about 15 weight percent; (h) optionally, one or a plurality of fats, wherein the fats are (d) Finsolv TN, wherein the Finsolv TN is present in the present in the composition in a combined amount rang composition in an amount ranging from about 10 to ing from about 0 to about 12 weight percent; and about 20 weight percent; (i) optionally, one or a plurality of flavorings, wherein the 30 (e) bees wax, wherein the bees wax is present in the com flavorings are present in the base composition in a com position in an amount ranging from about 6 to about 16 bined amount ranging from about 0 to about 3.5 weight weight percent; percent; (f) one or a plurality of plant oils or plant seed oils, wherein wherein the composition is in a sold or semi-solid form. 35 the plant or plant seed oils are present in the composition Preferred Subsequent (improved) active agent-containing in a combined amount ranging from about 12.5 to about compositions of the invention include those that are described 37.5 weight percent; below. (g) one or a plurality of fatty alcohols, wherein the fatty Non-Flavored Compositions Including Active Agent(s) alcohols are present in the composition in a combined (OTC and No Flavor) 40 amount ranging from about 15 to about 25 weight per In another aspect, the present invention provides a compo cent; and sition for topical application to the skin of a mammal for (h) one or a plurality of fats, wherein the fats are present in repairing, improving or fully healing a skin disorder, disease the composition in a combined amount ranging from or condition, or for causing the mammal’s skin to experience about 2 to about 12 weight percent; a reduction in pain, Soreness or itchiness, or an increase in 45 wherein the composition is in a sold or semi-solid form. Soothing, softening or conditioning, or a combination thereof, Flavored Compositions Including Active Agent(s) comprising: (OTC and Including Flavoring) (a) one or a plurality of active agents, such as hydrocorti In another aspect, the present invention provides a compo Sone, wherein the active agents are present in the com sition for topical application to the skin of a mammal for positionina combined amount ranging from about 0.1 to 50 repairing, improving or fully healing a skin disorder, disease about 3 weight percent; or condition, or for causing the mammal’s skin to experience (b) FANCOLVB, wherein the FANCOLVB is present in a reduction in pain, Soreness or itchiness, or an increase in the composition in an amount ranging from about 6 to Soothing, softening or conditioning, or a combination thereof, about 16 weight percent; comprising: (c) Natunola Castor 1023, wherein the Natunola Castor 55 (a) one or a plurality of active agents, such as hydrocorti 1023 is present in the composition in an amount ranging Sone, wherein the active agents are present in the com from about 5 to about 15 weight percent; position in a combined amount ranging from about 0.1 to (d) Finsolv TN, wherein the Finsolv TN is present in the about 3 weight percent; composition in an amount ranging from about 10 to (b) FANCOLVB, wherein the FANCOL VB is present in about 20 weight percent; 60 the composition in an amount ranging from about 6 to (e) bees wax, wherein the bees wax is present in the com about 16 weight percent; position in an amount ranging from about 6 to about 16 (c) Natunola Castor 1023, wherein the Natunola Castor weight percent; 1023 is present in the composition in an amount ranging (f) one or a plurality of plant oils or plant seed oils, wherein from about 5 to about 15 weight percent; the plant or plant seed oils are present in the composition 65 (d) Finsolv TN, wherein the Finsolv TN is present in the in a combined amount ranging from about 12.5 to about composition in an amount ranging from about 10 to 37.5 weight percent; about 20 weight percent; US 8,685,381 B2 21 22 (e) bees wax, wherein the bees wax is present in the com ing or fully healing a skin disorder, disease or condition of the position in an amount ranging from about 6 to about 16 mammal, or for causing the mammal’s skin to experience a weight percent; reduction in pain, Soreness or itchiness, or an increase in (f) one or a plurality of plant oils or plant seed oils, wherein Soothing, softening or conditioning, or a combination thereof, the plant or plant seed oils are present in the composition 5 and wherein the temperature of the composition is optionally in a combined amount ranging from about 12.0 to about elevated to a temperature above ambient temperature prior to 37.0 weight percent; topically applying the composition to the mammal’s skin. (g) one or a plurality of fatty alcohols, wherein the fatty In still another aspect, the present invention provides a alcohols are present in the composition in a combined method for repairing, improving or fully healing a skin dis amount ranging from about 15 to about 25 weight per 10 order, disease or condition of a mammal, or for causing the cent; mammal’s skin to experience a reduction in pain, Soreness or (h) one or a plurality of fats, wherein the fats are present in itchiness, or an increase in Soothing, softening or condition the composition in a combined amount ranging from ing, or a combination thereof, consisting of (or consisting about 2 to about 12 weight percent; and essentially of) topically applying to the mammal’s skin on a (i) one or a plurality of flavorings, where the flavorings are 15 regular basis at least one or two applications of one of the present in the composition in a combined amount rang above compositions, wherein the amount of the composition ing from about 0.1 to about 2.5 weight percent; that is applied to the skin of the mammal is an amount that is wherein the composition is in a sold or semi-solid form. effective for repairing, improving or fully healing a skin dis In another aspect, the present invention provides a compo order, disease or condition of the mammal, or for causing the sition for topical application to the skin of a mammal for mammal’s skin to experience a reduction in pain, Soreness or repairing, improving or fully healing a skin disorder, disease itchiness, or an increase in Soothing, softening or condition or condition, or for causing the mammal’s skin to experience ing, or a combination thereof. a reduction in pain, Soreness or itchiness, or an increase in Methods of Production Soothing, softening or conditioning, or a combination thereof, consisting of (or consisting essentially of): 25 Original (Specific) Formulations (a) one or a plurality of active agents, such as hydrocorti Sone, wherein the active agents are present in the com In still another aspect, the present invention provides a positionina combined amount ranging from about 0.1 to method for producing one of the above compositions in a about 3 weight percent; Solid or semi-solid form comprising the following steps in (b) FANCOLVB, wherein the FANCOLVB is present in 30 any suitable order: the composition in an amount ranging from about 6 to (a) optionally, heating a combined amount of one or a about 16 weight percent; plurality of plant oils that are sufficient, in combination (c) Natunola Castor 1023, wherein the Natunola Castor with one or more other ingredients, for producing a 1023 is present in the composition in an amount ranging composition in a Solid or semi-solid form to a tempera from about 5 to about 15 weight percent; 35 ture, and for a period of time, that are effective for evenly (d) Finsolv TN, wherein the Finsolv TN is present in the heating the plant oil(s): composition in an amount ranging from about 10 to (b) adding an amount of FANCOLVB that is sufficient, in about 20 weight percent; a combination with one or more other method ingredi (e) bees wax, wherein the bees wax is present in the com ents, for producing a composition in a Solidorsemi-solid position in an amount ranging from about 6 to about 16 40 form to any plant oils heated in step (a), and heating the weight percent; FANCOLVB at a temperature, and for a period of time, (f) one or a plurality of plant oils or plant seed oils, wherein that are effective for evenly heating the FANCOL VB, the plant or plant seed oils are present in the composition and for dissolving the FANCOL VB in any such plant in a combined amount ranging from about 12.0 to about oils; 37.0 weight percent; 45 (c) adding an amount of Natunola Castor 1023 that is (g) one or a plurality of fatty alcohols, wherein the fatty Sufficient, in a combination with one or more other alcohols are present in the composition in a combined method ingredients, for producing a composition in a amount ranging from about 15 to about 25 weight per solid or semi-solid form to the product of step (b), and cent; heating the Natunola Castor 1023 at a temperature, and (h) one or a plurality of fats, wherein the fats are present in 50 for a period of time, that are effective for dissolving the the composition in a combined amount ranging from Natunola Castor 1023 in such product; about 2 to about 12 weight percent; and (d) adding an amount of bees wax that is Sufficient, in a (i) one or a plurality of flavorings, where the flavorings are combination with one or more other method ingredients, present in the composition in a combined amount rang for producing a composition in a solid or semi-solid ing from about 0.1 to about 2.5 weight percent; 55 form to the product of step (c), and heating the beeswax wherein the composition is in a sold or semi-solid form. at a temperature, and for a period of time, that are effec Method of Treatment tive for dissolving the bees wax in such product; In still another aspect, the present invention provides a (e) optionally, adding a combined amount of one or a method for repairing, improving or fully healing a skin dis plurality of fatty alcohols that are sufficient, in a combi order, disease or condition of a mammal, or for causing the 60 nation with one or more other method ingredients, for mammal’s skin to experience a reduction in pain, Soreness or producing a composition in a Solid or semi-solid form to itchiness, or an increase in Soothing, softening or condition the product of step (d), and heating the fatty alcohols at ing, or a combination thereof, comprising topically applying a temperature, and for a period of time, that are effective to the mammal’s skin on a regular basis at least one or two for dissolving the fatty alcohols in Such product; applications of one of the above compositions, wherein the 65 (f) optionally, adding a combined amount of one or a plu amount of the composition that is applied to the skin of the rality of fats that are Sufficient for producing, in a com mammal is an amount that is effective for repairing, improv bination with one or more other method ingredients, a US 8,685,381 B2 23 24 composition in a solid or semi-solid form to the product form to any plant oils heated in step (a), and heating the of step (d) or step (e), and heating the fats at a tempera FANCOLVB at a temperature, and for a period of time, ture, and for a period of time, that are effective for that are effective for evenly heating the FANCOL VB, dissolving the fats in Such product; and for dissolving the FANCOL VB in any such plant (g) adding an amount of Finsolv TN that is Sufficient, in a oils, with an amount of mixing as is required, for combination with one or more other method ingredients, example, from about 75° C. to about 85°C.: for producing a composition in a solid or semi-solid (c) adding an amount of bees wax that is sufficient, in a form to the product of step (d), (e) or (f), and heating the combination with one or more other method ingredients, Finsolv TN at a temperature, and for a period of time, for producing a composition in a solid or semi-solid that are effective for dissolving the Finsolv TN in such 10 product; form to the product of step (b), and heating the beeswax (h) cooling the mixture of step (g) to a temperature that at a temperature, and for a period of time, that are effec permits one or a plurality of active ingredients to be tive for dissolving the beeswax in such product, with an mixed therewith out significantly reducing the activities amount of mixing as is required, for example, from of the active ingredients, or rending them inactive; 15 about 75° C. to about 85°C.; (i) mixing a combined amount of one or a plurality of active (d) adding one or a plurality offatty alcohols in a combined ingredients that is sufficient, when present in a base amount that is sufficient, in a combination with one or composition in Solid or semi-solid form, for repairing, more other method ingredients, for producing a compo improving or healing a skin disorder, disease or condi sition in a solid or semi-solid form to the product of step tion of a mammal, or for causing the mammal’s skin to (c), and heating the fatty alcohols at a temperature, and experience a reduction in pain, Soreness or itchiness, or for a period of time, that are effective for dissolving the an increase in soothing, softening or conditioning, or a fatty alcohols in Such product, with an amount of mixing combination thereof, with the product of step (h) at a as is required, for example, from about 75° C. to about temperature, and for a period of time, that is sufficient 850 C. for dissolving the active ingredients in Such product; 25 (e) adding one or a plurality of fats in a combined amount () optionally, cooling the mixture of step (i) to a tempera that is sufficient for producing, in a combination with ture that permits one or a plurality of flavorings to be one or more other method ingredients, a composition in mixed therewith out significantly reducing the flavor of a solid or semi-solid form to the product of step (d), and the flavorings, or rending them flavorless; heating the fats at a temperature, and for a period of time, (k) optionally, mixing a combined amount of one or a 30 that are effective for dissolving the fats in such product, plurality of flavorings that is sufficient, when present in with an amount of mixing as is required, for example, the composition, for providing the composition with a from about 75° C. to about 85°C.: desirable or distinct flavor, or for partially or fully mask (f) adding an amount of Finsolv TN that is sufficient, in a ing one or more bitter or undesirable flavors present combination with one or more other method ingredients, therein, or a combination thereof, with the product of 35 for producing a composition in a solid or semi-solid step (i) or () at a temperature, and for a period of time, form to the product of step (e), and heating the Finsolv that is sufficient for uniformly distributing the flavorings TN at a temperature, and for a period of time, that are throughout Such product; effective for dissolving the Finsolv TN in such product, (1) optionally, determining the concentration of the active with an amount of mixing as is required, for example, ingredients in the mixture of step (i), () or (k); and 40 from about 75° C. to about 85°C.; (m) optionally, pouring or transferring the product of step (g) adding an amount of Natunola Castor 1023 that is (i), (), (k) or (1) into one or a plurality of molds and Sufficient, in a combination with one or more other allowing the product to harden, set or solidify therein; method ingredients, for producing a composition in a wherein the composition is in a solid or semi-solid form. solid or semi-solid form to the product of step (f), and 45 heating the Natunola Castor 1023 at a temperature, and Subsequent (Improved) Formulations for a period of time, that are effective for dissolving the Natunola Castor 1023 in such product, with an amount Preferred subsequent (improved) methods for producing of mixing as is required, for example, from about 75°C. preferred base and active agent-containing compositions of to about 85°C. for a period of time ranging from about the invention include those that are described below. 50 1 hour to about 1.5 hours; and Non-Flavored Base Compositions (Non-OTC and No Fla (h) optionally, pouring or transferring the product of step vor) (g) into one or a plurality of molds and allowing the In another aspect, the present invention provides a method product to partially or fully harden, set or solidify for producing a topical base composition that does not therein; include a flavoring ingredient or an active agent in a solid or 55 wherein the composition is in a solid or semi-solid form. semi-solid form comprising the following steps in any Suit Flavored Base Compositions (Non-OTC, but Including able order: Flavoring) (a) heating one or a plurality of plant oils in a combined In another aspect, the present invention provides a method amount that is sufficient, in combination with one or for producing a topical base composition that includes a fla more other ingredients, for producing a composition in a 60 Voring ingredient, but that does not include an active agent, in Solid or semi-solid form to a temperature, and for a a solid or semi-solid form comprising the following steps in period of time, that are effective for evenly heating the any suitable order: plant oil(s), with an amount of mixing as may be (a) heating one or a plurality of plant oils in a combined required, for example, from about 75°C. to about 85°C.; amount that is sufficient, in combination with one or (b) adding an amount of FANCOLVB that is sufficient, in 65 more otheringredients, for producing a composition in a a combination with one or more other method ingredi Solid or semi-solid form to a temperature, and for a ents, for producing a composition in a solid or semi-solid period of time, that are effective for evenly heating the US 8,685,381 B2 25 26 plant oil(s), with an amount of mixing as is required, for for example, from about 70° C. to about 80° C. for a example, from about 75° C. to about 85°C.; period of time ranging from about 15 to about 20 min (b) adding an amount of FANCOLVB that is sufficient, in utes; and a combination with one or more other method ingredi () optionally, pouring or transferring the product of step (i) ents, for producing a composition in a solid or semi-solid 5 into one or a plurality of molds and allowing the product form to any plant oils heated in step (a), and heating the to partially or fully harden, set or solidify therein; FANCOLVB at a temperature, and for a period of time, wherein the composition is in a solid or semi-solid form. that are effective for evenly heating the FANCOL VB, Non-Flavored Compositions Including Active Agent(s) and for dissolving the FANCOL VB in any such plant (OTC and No Flavor) oils, with an amount of mixing as is required, for 10 In another aspect, the present invention provides a method example, from about 75° C. to about 85°C.; for producing a topical active-agent containing composition (c) adding an amount of bees wax that is sufficient, in a that does not include a flavoring ingredient in a Solid or combination with one or more other method ingredients, semi-solid form comprising the following steps in any Suit for producing a composition in a solid or semi-solid able order: form to the product of step (b), and heating the beeswax 15 (a) heating one or a plurality of plant oils in a combined at a temperature, and for a period of time, that are effec amount that is sufficient, in combination with one or tive for dissolving the beeswax in such product, with an more otheringredients, for producing a composition in a amount of mixing as is required, for example, from Solid or semi-solid form to a temperature, and for a about 75° C. to about 85°C.; period of time, that are effective for evenly heating the (d) adding one or a plurality offatty alcohols in a combined plant oil(s), for example, with an amount of mixing as is amount that is sufficient, in a combination with one or required, from about 75° C. to about 85°C.: more other method ingredients, for producing a compo (b) adding an amount of FANCOLVB that is sufficient, in sition in a solid or semi-solid form to the product of step a combination with one or more other method ingredi (c), and heating the fatty alcohols at a temperature, and ents, for producing a composition in a Solidorsemi-solid for a period of time, that are effective for dissolving the 25 form to any plant oils heated in step (a), and heating the fatty alcohols in Such product, with an amount of mixing FANCOLVB at a temperature, and for a period of time, as is required, for example, from about 75° C. to about that are effective for evenly heating the FANCOL VB, 850 C. and for dissolving the FANCOL VB in any such plant (e) adding one or a plurality of fats in a combined amount oils, with an amount of mixing as is required, for that is sufficient for producing, in a combination with 30 example, from about 75° C. to about 85°C.: one or more other method ingredients, a composition in (c) adding an amount of bees wax that is sufficient, in a a solid or semi-solid form to the product of step (d), and combination with one or more other method ingredients, heating the fats at a temperature, and for a period of time, for producing a composition in a solid or semi-solid that are effective for dissolving the fats in such product, form to the product of step (b), and heating the beeswax with an amount of mixing as is required, for example, 35 at a temperature, and for a period of time, that are effec from about 75° C. to about 85°C.; tive for dissolving the beeswax in such product, with an (f) adding an amount of Finsolv TN that is sufficient, in a amount of mixing as is required, for example, from combination with one or more other method ingredients, about 75° C. to about 85°C.; for producing a composition in a solid or semi-solid (d) adding one or a plurality offatty alcohols in a combined form to the product of step (e), and heating the Finsolv 40 amount that is sufficient, in a combination with one or TN at a temperature, and for a period of time, that are more other method ingredients, for producing a compo effective for dissolving the Finsolv TN in such product, sition in a solid or semi-solid form to the product of step with an amount of mixing as is required, for example, (c), and heating the fatty alcohols at a temperature, and from about 75° C. to about 85°C.; for a period of time, that are effective for dissolving the (g) adding an amount of Natunola Castor 1023 that is 45 fatty alcohols in Such product, with an amount of mixing Sufficient, in a combination with one or more other as is required, for example, from about 75° C. to about method ingredients, for producing a composition in a 850 C. solid or semi-solid form to the product of step (f), and (e) adding one or a plurality of fats in a combined amount heating the Natunola Castor 1023 at a temperature, and that is sufficient for producing, in a combination with for a period of time, that are effective for dissolving the 50 one or more other method ingredients, a composition in Natunola Castor 1023 in such product, with an amount a solid or semi-solid form to the product of step (d), and of mixing as is required, for example, from about 75°C. heating the fats at a temperature, and for a period of time, to about 85°C. for a period of time ranging from about that are effective for dissolving the fats in such product, 1 hour to about 1.5 hours; with an amount of mixing as is required, for example, (h) cooling the product of step (g) to a temperature that 55 from about 75° C. to about 85°C.; permits one or a plurality of flavoring ingredients to be (f) adding an amount of Finsolv TN that is sufficient, in a mixed therewith out significantly reducing the flavor of combination with one or more other method ingredients, the flavoring ingredients, or rending them flavorless, for for producing a composition in a solid or semi-solid example, from about 70° C. to about 80° C.; form to the product of step (e), and heating the Finsolv (i) adding one or a plurality of flavoring ingredients in a 60 TN at a temperature, and for a period of time, that are combined amount that is sufficient, when present in the effective for dissolving the Finsolv TN in such product, composition, for providing the composition with a desir with an amount of mixing as is required, for example, able or distinct flavor, or for partially or fully masking from about 75° C. to about 85°C.; one or more bitter or undesirable flavors present therein, (g) adding an amount of Natunola Castor 1023 that is or a combination thereof, with the product of step (h) at 65 Sufficient, in a combination with one or more other a temperature, and for a period of time, that is sufficient method ingredients, for producing a composition in a for distributing the flavorings throughout such product, solid or semi-solid form to the product of step (f), and US 8,685,381 B2 27 28 heating the Natunola Castor 1023 at a temperature, and heating the fats at a temperature, and for a period of time, for a period of time, that are effective for dissolving the that are effective for dissolving the fats in such product, Natunola Castor 1023 in such product, with an amount with an amount of mixing as is required, for example, of mixing as is required, for example, from about 75°C. from about 75° C. to about 85°C.; to about 85°C. for a period of time ranging from about (f) adding an amount of Finsolv TN that is sufficient, in a 1 hour to about 1.5 hours; combination with one or more other method ingredients, (h) adding one or a plurality of active ingredients in a for producing a composition in a solid or semi-solid combined amount that is Sufficient, when present in a form to the product of step (e), and heating the Finsolv product of step (g) in a Solid or semi-solid form, for TN at a temperature, and for a period of time, that are repairing, improving or fully healing a skin disorder, 10 effective for dissolving the Finsolv TN in such product, disease, adverse condition or other malady of a mam with an amount of mixing as is required, for example, mal, or for causing the mammal’s skin to experience a from about 75° C. to about 85°C.; reduction in pain, Soreness or itchiness, oran increase in (g) adding an amount of Natunola Castor 1023 that is Soothing, softening or conditioning, or a combination Sufficient, in a combination with one or more other thereof, with the product of step (g) at a temperature, and 15 method ingredients, for producing a composition in a for a period of time, that is sufficient for dissolving the solid or semi-solid form to the product of step (f), and active ingredients in Such product, for example, from heating the Natunola Castor 1023 at a temperature, and about 75° C. to about 85°C.; and for a period of time, that are effective for dissolving the (i) optionally, pouring or transferring the product of step Natunola Castor 1023 in such product, with an amount (h) into one or a plurality of molds and allowing the of mixing as is required, for example, from about 75°C. product to partially or fully harden, set or solidify to about 85°C. for a period of time ranging from about therein; 1 hour to about 1.5 hours; wherein the composition is in a solid or semi-solid form. (h) adding one or a plurality of active ingredients in a Flavored Compositions Including Active Agent(s) combined amount that is Sufficient, when present in a (OTC and Including Flavoring) 25 product of step (g) in a solid or semi-solid form, for In another aspect, the present invention provides a method repairing, improving or fully healing a skin disorder, for producing a topical active-agent containing composition disease, adverse condition or other malady of a mam that includes at least one flavoring ingredient in a solid or mal, or for causing the mammal’s skin to experience a semi-solid form comprising the following steps in any Suit reduction in pain, Soreness or itchiness, oran increase in able order: 30 Soothing, softening or conditioning, or a combination (a) heating one or a plurality of plant oils in a combined thereof, with the product of step (g) at a temperature, and amount that is sufficient, in combination with one or for a period of time, that is sufficient for dissolving the more other ingredients, for producing a composition in a active ingredients in Such product, for example, from Solid or semi-solid form to a temperature, and for a about 75° C. to about 85°C.; period of time, that are effective for evenly heating the 35 (i) cooling the product of step (h) to a temperature that plant oil(s), with an amount of mixing as is required, for permits one or a plurality of flavoring ingredients to be example, from about 75° C. to about 85°C.; mixed therewith out significantly reducing the flavor of (b) adding an amount of FANCOLVB that is sufficient, in the flavoring ingredients, or rending them flavorless, for a combination with one or more other method ingredi example, from about 70° C. to about 80° C.: ents, for producing a composition in a solid or semi-solid 40 () adding one or a plurality of flavoring ingredients in a form to any plant oils heated in step (a), and heating the combined amount that is sufficient, when present in the FANCOLVB at a temperature, and for a period of time, composition, for providing the composition with a desir that are effective for evenly heating the FANCOL VB, able or distinct flavor, or for partially or fully masking and for dissolving the FANCOL VB in any such plant one or more bitter or undesirable flavors present therein, oils, with an amount of mixing as is required, for 45 or a combination thereof, with the product of step (i) at example, from about 75° C. to about 85°C.; a temperature, and for a period of time, that is sufficient (c) adding an amount of bees wax that is sufficient, in a for distributing the flavorings throughout such product, combination with one or more other method ingredients, for example, from about 70° C. to about 80° C. for a for producing a composition in a solid or semi-solid period of time ranging from about 15 to about 20 min form to the product of step (b), and heating the beeswax 50 utes; and at a temperature, and for a period of time, that are effec (k) optionally, pouring or transferring the product of step tive for dissolving the beeswax in such product, with an () into one or a plurality of molds and allowing the amount of mixing as is required, for example, from product to partially or fully harden, set or solidify about 75° C. to about 85°C.; therein; (d) adding one or a plurality offatty alcohols in a combined 55 wherein the composition is in a solid or semi-solid form. amount that is sufficient, in a combination with one or In yet other aspects, the present invention provides com more other method ingredients, for producing a compo positions that are produced by the above methods. sition in a solid or semi-solid form to the product of step (c), and heating the fatty alcohols at a temperature, and BRIEF DESCRIPTION OF THE DRAWINGS for a period of time, that are effective for dissolving the 60 fatty alcohols in Such product, with an amount of mixing The patent or application file contains at least one drawing as is required, for example, from about 75° C. to about and/or photograph executed in color. Copies of this patent or 850 C. patent application publication with color drawing(s) and/or (e) adding one or a plurality of fats in a combined amount photograph(s) will be provided by the Office upon request that is sufficient for producing, in a combination with 65 and payment of the necessary fee. one or more other method ingredients, a composition in FIG. 1 is a photograph showing two roll-up, Stick-shaped, a solid or semi-solid form to the product of step (d), and hydrocortisone-containing compositions of the invention, US 8,685,381 B2 29 30 prepared in a Solid form in a manner described in Example 1, and the eczema that is present on the chin in FIGS. 6 and 7. and packaged into two very different sized plastic containers respectively, completely disappeared (i.e., had a 100% (having corresponding plastic lids). The Smaller sized con improvement). tainer includes about 0.15 ounce of the composition, and FIG. 9 is a set of two photographs showing the dorsal measures about aspect of the left hand of a fifty-year-old female patient hav 6.0 cm in length and about 1.5 cm in diameter, and would ing psoriasis, whose initials are PT. FIG.9A shows this hand likely be used with lips, and the larger sized container as it was present prior to receiving any type of treatment with includes about 0.50 ounce of the composition, and measures any compositions of the invention for the dryness, cracks, and about 7.6 cm in length and about 2.0 cm in diameter, and cuts appearing thereon, with an emphasis on the thumb and 10 the index finger. FIG.9B shows the same dorsal aspect that is would likely be used with larger areas of the skin or body. As shown in FIG.9A, but as this hand existed after being treated is shown in FIG. 1, the lower portion of each of the containers only with a hydrocortisone-containing Solid composition of (farthest away from the lids) may be rotated or twisted in a the invention in a form of a large Solid stick, prepared in the counter clockwise (or clockwise or other) manner to forcibly manner described in Example 6, and having the larger size cause the Solid compositions to protrude outwards from the 15 shown in FIG. 1, with about 100 applications of about 0.5 containers, thereby permitting a user to topically apply the ml/application of the composition being applied to the palm protruding Solid compositions to one or more areas of the spaced equally apart over a period of thirty days (i.e., about user's skin. The quarter shown in FIG. 1 is illustrated for the 3-4 applications per day). A comparison of the left hand that purposes of having a size comparison of the two different is shown in FIG. 9A with the left hand that is shown in FIG. sized containers shown in FIG. 1. 9B shows that the dryness and cracks that are shown in FIG. FIG. 2 is a photograph showing the left forearm of a six 9A are significantly moisturized and reduced, and that the teen-year-old male patient with eczema, as the forearm was cuts that are shown in FIG.9A have completely disappeared present prior to receiving any type of treatment for the two (i.e., have a 100% improvement). plaques (elevated, Solid, Superficial lesions greater than 0.5 FIG. 10 is a set of two photographs showing the palmar cm in diameter) appearing thereon. 25 aspect of the same left hand of the same female patient that is FIG.3 is a photograph showing the same forearm (with two pictured in FIG. 9. FIG. 10A shows this hand as it was present plaques) that is shown in FIG. 2 (i.e., a view that is closer up). prior to receiving any type of treatment with any composi FIG. 4 is a photograph showing the left wrist of the same tions of the invention for the dryness, cracks, and cuts appear male patient discussed in FIGS. 2 and 3, as the wrist was ing thereon, with an emphasis on the thumb and the palm. 30 FIG. 10B shows the same palm that is shown in FIG. 10A, but present prior to receiving any type of treatment for the eczema as the palm existed after being treated only with a hydrocor appearing thereon. tisone-containing solid composition of the inventionina form FIG. 5 is a photograph showing the same forearm that is of a large Solid stick, prepared in the manner described in shown in FIG. 2, but as the forearm existed after being treated Example 6, and having the larger size shown in FIG. 1, with only with a hydrocortisone-containing Solid composition of 35 about 100 applications of about 0.5 ml/application of the the invention, prepared in the manner described in Example 1, composition being applied to the palm Spaced equally apart and having the larger size shown in FIG. 1, with twenty over a period of thirty days (i.e., about 3-4 applications per applications of about 0.5 ml/application of the composition day). A comparison of the left hand that is shown in FIG. 10A being applied to the forearm spaced equally apart over a with the left hand that is shown in FIG. 10B shows that the period of seven days. FIG. 5 shows that the two plaques that 40 dryness and cracks that are shown in FIG. 10A are signifi are present on the forearm shown in FIG. 2 completely dis cantly moisturized and reduced, and that the cuts that are appeared (i.e., had a 100% improvement). FIG. 5 also shows shown in FIG. 10A have completely disappeared (i.e., have a the same wrist that is shown in FIG. 4, but as the wrist existed 100% improvement). after being treated only with a hydrocortisone-containing FIG. 11 is a set of two photographs showing the dorsal Solid composition of the invention, prepared in the manner 45 aspect of the right hand of the same female patient whose left described in Example 1, and having the larger size shown in hand is pictured in FIG.9 and FIG. 10. FIG. 11A shows this FIG. 1, with thirty applications of the composition being hand as it was present prior to receiving any type of treatment applied to the wrist spaced equally apart over a period of with any compositions of the invention for the dryness, seven days. FIG.5 shows that the eczema that is present on the cracks, and cuts appearing thereon, with an emphasis on the wrist in FIG. 4 completely disappeared (i.e., had a 100% 50 thumb, index finger, and knuckles. FIG. 11B shows the same improvement). dorsal aspect that is shown in FIG. 11A, but as the hand FIG. 6 is a photograph showing the full face of the same existed after being treated only with a hydrocortisone-con male patient discussed in FIGS. 2 and 3, as the face was taining solid composition of the invention in a form of a large present prior to receiving any type of treatment for the dry Solid stick, prepared in the manner described in Example 6. skin appearing thereon. 55 and having the larger size shown in FIG. 1, with about 100 FIG. 7 is a photograph showing the chin area (with eczema) applications of about 0.5 ml/application of the composition of the same face that is shown in FIG. 6 (i.e., a view that is being applied to the palm spaced equally apart over a period closer up). of thirty days (i.e., about 3-4 applications per day). A com FIG. 8 is a photograph showing the same face that is shown parison of the right hand that is shown in FIG. 11A with the in FIG. 6 (including the same chin that is shown in FIG. 7), but 60 right hand that is shown in FIG. 11B shows that the dryness as the face (and chin) existed after being treated only with a and cracks that are shown in FIG. 11A are significantly mois hydrocortisone-containing Solid composition of the inven turized and reduced, and that the cuts that are shown in FIG. tion, prepared in the manner described in Example 1, and 11A have completely disappeared (i.e., have a 100% having the larger size shown in FIG. 1, with twenty applica improvement). tions of about 0.5 ml/application being applied to the face 65 FIG. 12 is a set of two photographs showing the palmar spaced equally apart over a period of seven days. FIG. 8 aspect of the right hand of the same female patient whose left shows that the dry skin (on the lips) that is present on the face hand is pictured in FIG. 9-11. FIG. 12A shows this hand as it US 8,685,381 B2 31 32 was present prior to receiving any type of treatment with any existed after being treated only with a hydrocortisone-con compositions of the invention for the dryness, cracks, and taining Solid composition of the invention in a form of a small cuts appearing thereon, with an emphasis on the palm, thumb, Solid stick, prepared in the manner described in Example 6. and index finger. FIG.12B shows the same palm that is shown and having the smaller size shown in FIG. 1, with 21 appli in FIG. 12A, but as the palm existed after being treated only 5 cations of about 0.1 ml/application of the composition being with a hydrocortisone-containing Solid composition of the applied to the nasolabial folds spaced equally apart over a invention in a form of a large Solid stick, prepared in the period of seven days (i.e., 3 applications per day). A compari manner described in Example 6, and having the larger size son of the face that is shown in FIG. 15A with the face that is shown in FIG. 1, with about 100 applications of about 0.5 shown in FIG. 15B shows that the scaling and erythema that ml/application of the composition being applied to the palm 10 spaced equally apart over a period of thirty days (i.e., about is shown in FIG. 15A was significantly reduced. 3-4 applications per day). A comparison of the right hand that FIG. 16 is a set of two photographs showing the face of a is shown in FIG. 12A with the right hand that is shown in FIG. forty-one-year-old male patient having seborrheic dermatitis, 12B shows that the dryness and cracks that are shown in FIG. whose initials are JT. FIG. 16A shows this face as it was 12A are significantly moisturized and reduced, and that the 15 present prior to receiving any type of treatment for the seb cuts that are shown in FIG. 12A have completely disappeared orrheic dermatitis appearing thereon. FIG. 16B shows the (i.e., have a 100% improvement). same face that is shown in FIG. 16A, but as the face existed FIG. 13 is a set of two photographs showing the dorsal after being treated only with a hydrocortisone-containing aspects of the left and right hands of the same female patient solid composition of the invention in a form of a small solid whose hands are pictured in FIGS. 9-12. FIG. 13A shows the Stick, prepared in the manner described in Example 6, and left and right hands as they were present prior to receiving any having the smaller size shown in FIG. 1, with 21 applications type of treatment with any compositions of the invention for of about 0.1 ml/application of the composition being applied the dryness, cracks, and cuts appearing thereon, with an to the Seborrheic dermatitis present on the face spaced equally emphasis on the thumbs, index fingers, and knuckles of both apart over a period of 7 days (i.e., 3 applications per day). A hands. FIG. 13B shows the same left and right hands that are 25 comparison of the face that is shown in FIG.16A with the face shown in FIG.13A, but as the left and right hands existed after that is shown in FIG. 16B shows that the seborrheic derma being treated only with a hydrocortisone-containing Solid titis, scaling and erythema that is shown in FIG. 16A was composition of the invention in a form of a large Solid Stick, significantly reduced. prepared in the manner described in Example 6, and having FIG. 17 is a set of two photographs showing the face of a the larger size shown in FIG.1, with about 100 applications of 30 about 0.5 ml/application of the composition being applied to seventeen-year-old female patient having eczema, whose ini the palm spaced equally apart over a period of thirty days (i.e., tials are SR. FIG. 17A shows this face as it was present prior about 3-4 applications per day). A comparison of the left and to receiving any type of treatment for the eczema appearing right hands that are shown in FIG. 13A with the left and right thereon. FIG. 17B shows the same face that is shown in FIG. hands that are shown in FIG. 13B show that the dryness and 35 17A, but as the face existed after being treated only with a cracks that are shown in FIG. 13A are significantly moistur hydrocortisone-containing Solid composition of the invention ized and reduced, and that the cuts that are shown in FIG. 13A in a form of a small solid stick, prepared in the manner have completely disappeared (i.e., have a 100% improve described in Example 6, and having the Smaller size shown in ment). FIG.1, with 21 applications of about 0.1 ml/application of the FIG. 14 is a set of two photographs showing the palmar 40 composition being applied to the eczema spaced equally apart aspects of the left and right hands of the same female patient over a period of 7 days (i.e., 3 applications per day). A com whose hands are pictured in FIGS. 9-13. FIG. 14A shows the parison of the face that is shown in FIG.17A with the face that left and right hands as they were present prior to receiving any is shown in FIG. 17B shows that the eczema that is shown in type of treatment with any compositions of the invention for FIG. 17A was significantly reduced (by about 80%). the dryness, cracks, and cuts appearing thereon, with an 45 FIG. 18 is a set of two photographs showing the left hand of emphasis on the palms, thumbs, and index fingers of both a fifty-three-year-old female patient having eczema, whose hands. FIG. 14B shows the same left and right hands that are initials are PR. FIG. 18A shows this patient’s left hand as it shown in FIG. 14A, but as the left and right hands existed after was present prior to receiving any type of treatment for the being treated only with a hydrocortisone-containing Solid eczema appearing just below the base of the ring finger. FIG. composition of the invention in a form of a large Solid Stick, 50 18B shows the same hand that is shown in FIG. 18A, but as the prepared in the manner described in Example 6, and having hand existed after being treated only with the hydrocortisone the larger size shown in FIG.1, with about 100 applications of containing solid composition (in the manner described about 0.5 ml/application of the composition being applied to above). A comparison of the hand that is shown in FIG. 18A the palm spaced equally apart overa period of thirty days (i.e., with the hand that is shown in FIG. 18B shows that the eczema about 3-4 applications per day). A comparison of the left and 55 right hands that are shown in FIG. 14A with the left and right that is shown in FIG. 18A had completely cleared (i.e., a hands that are shown in FIG. 14B show that the dryness and 100% improvement). cracks that are shown in FIG. 14A are significantly moistur FIG. 19 is a set of two photographs showing the right hand ized and reduced, and that the cuts that are shown in FIG. 14A of the same fifty-three-year-old female patient having have completely disappeared (i.e., have a 100% improve 60 eczema, whose initials are PR. FIG. 19A shows this patients ment). right hand as it was present prior to receiving any type of FIG. 15 is a set of two photographs showing the face of a treatment for the eczema appearing thereon at the base of the thirty-five-year-old female patient having seborrheic derma fourth finger. FIG. 19B shows the same hand that is shown in titis, whose initials are SN. FIG.15A shows this face as it was FIG. 19A, but as the hand existed after being treated only with present prior to receiving any type of treatment for the 65 the hydrocortisone-containing Solid composition (in the man erythema of the nasolabial folds appearing thereon. FIG.15B ner described above). A comparison of the hand that is shown shows the same face that is shown in FIG. 15A, but as the face in FIG. 19A with the hand that is shown in FIG. 19B shows US 8,685,381 B2 33 34 that the eczema that is shown in FIG. 19A had completely period of time, preferably without an unreasonable risk of cleared (i.e., a 100% improvement). harm, injury, inflammation, irritation or allergic response to, or by, the skin, or illness or harm to the mammal. Persons of DETAILED DESCRIPTION OF THE PREFERRED ordinary skill in the art may readily determine whether or not EMBODIMENTS a particular base includes these characteristics. The phrase “diluent as is used herein means a substance or The present invention may be understood more readily by agent that dilutes, facilitates a physical separation of one or reference to the following detailed description of the pre more ingredients and/or makes thinner or weaker. Diluent ferred embodiments of the invention, and to the examples materials that are suitable for use with mammals could gen included therein. 10 erally include complex polysaccharides, carbohydrates, Definitions Smaller Sugars (dextrose, Sucrose and the like), dicalcium For purposes of clarity, various terms and phrases used phosphate, tricalcium phosphate, maltodextrin and water. throughout this specification and the appended claims are The term “distinctive' as is used herein means character defined in the manner set forth below. If a term or phrase used istic of identifying or serving to distinguish. For example, a in this specification, or in the appended claims, is not defined 15 distinctive taste may be a bitter taste, a sour taste, a Sweet below, or otherwise in this specification, the term or phrase taste, a salty taste, a fruity taste, a vanilla taste and/or the like. should be given its ordinary meaning. The term “eczema' as is used herein means a particular The terms “about and “approximate” as are used herein type of inflammatory reaction of the skin in which there are mean approximately, as is known, and may be determined, by typically tiny blister-like raised areas (vesicles) in the first those having ordinary skill in the art, and typically includes a stage followed by reddening (erythema), Swelling (edema), variation of a numeric value described herein by +0.2. bumps (papules), and crusting of the skin, and finally thick The phrase “ambient temperature' as is used herein means ening and Scaling of the skin. the temperature of the Surroundings, such as the temperature The term “effective' as is used herein in connection with a of a particular room. composition ingredient or composition, in many instances, The phrase “antioxidant agent” as is used herein means an 25 and depending upon the context, as may be determined by agent that has an ability to prevent, reduce or aid in the those having ordinary skill in the art, means that the ingredi prevention or reduction of an oxidation, degradation and/or ent, alone or in combination with one or more other ingredi other decomposition of one or more ingredients or compo ents, provides a composition with one or more of the qualities, nents, such as a fat or an oil, and/or to prevent, or aid in the characteristics and/or benefits that are described herein, or prevention of oxygen-based damage to hair, skin or other 30 that the composition has one or more of Such qualities, char cells. Antioxidant agents include, for example, various toco acteristics and/or benefits. Such as an activity resulting from pherol mixtures, edible acids (citric acid, ascorbic acid and an active ingredient present therein. the like), Vitamin A, vitamin C. vitamin E, beta-carotene, The term “emollient’ as is used herein means an ingredi Selenium, magnesium, herbal extracts, such as a Rosemary, ent, or combination of ingredients, that increases the softness Sage, Oregano, Ginger, Marjoram or Rosemary Oleoresins 35 of the skin, restores the skin and/or helps maintain water extract, plant phenols, such as Vanillin, elagic acid and Res and/or oils in the skin. Veratrol, and synthetic antioxidants, such as tertiary butylhy The term "emulsifier” as is used herein means any sub droquinone (TBHQ), butylated hydroxyamisole (BHA) or stance or agent that aids in the formation of an emulsion, Such butylated hydroxytoluene (BHT), or mixtures thereof. as egg yolk, egg lecithin, Soy lecithin and mono- and di The term "balm' as is used herein means a substance that 40 glycerides. typically is oily in nature, a Solid or semi-solid, and soothing The term "emulsion” as is used herein means a generally to the skin of a human being and/or animal when topically stable and homogeneous mixture of two liquids that do not applied thereto (either immediately or at a Subsequent time normally mix (i.e., they are immiscible between themselves), after one or a series of multiple applications), particularly Such as Vegetable oil and water, for example, milk and may when it includes one or more active agents, such as hydro 45 onnaise. Emulsions can be true colloids or less stable mix cortisone, and which may or may not have a pleasant (or other tures, which tend to separate in a short time. An emulsion can smell). Examples of balms include aloe, ChapStick R and often be broken down (i.e. the liquids separated) by factors compositions within the present invention. Such as mechanical manipulation, chemical effects and/or The phrase “carrier vehicle' as is used herein means a time. medium for, or capable of providing a controlled delivery of 50 The term “FANCOL VB” as is used herein means Buty one or a plurality of active agents to a mammal, or part rospermum Parkii Butter Limnanthes Alba Seed Oil, which thereof. Such as the skin. contains, or consists of vegetable derived lipids and sterol The term "component as is used herein means a part, enriched shea butter extract. Its INCI name is Limnanthes portion, element, constituent or ingredient, and is used inter Alba (Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea changeably with “ingredient' and "agent.” For example, in 55 Butter) Extract. It is commercially available from sources that connection with a composition of the invention, this term may are known by those having ordinary skill in the art, for mean an ingredient, or combination of ingredients, used in the example, from The Fanning Corporation (Chicago, Ill.) and composition, or a part, portion, element or constituent Elementis Specialties, Inc. (Hightstown, N.J.). thereof, depending upon the context in which this term is The term “fat’ as is used herein means any of the various used, which may readily be determined by those having ordi 60 saturated and/or unsaturated (including monounsaturated and nary skill in the art. polyunsaturated), hydrogenated or unhydrogenated soft The phrase “base' as is used herein refers to a carrier Solid, semisolid and/or Solid organic compounds that gener vehicle for one or a plurality of active agents, such as hydro ally comprise the glyceride esters offatty acids and associated cortisone, that may be applied to the skin of a normal and phosphatides, sterols, alcohols, hydrocarbons, ketones and/or healthy mammal (other than possibly having one more 65 related compounds, components thereof and/or mixtures or adverse skin conditions, disorders or diseases, as are dis other combinations thereof. Such components include, but cussed herein) in a reasonable quantity over a reasonable are not limited to, fatty acids, glycerides (mono-, di- and tri-). US 8,685,381 B2 35 36 ethyl and other esters of fatty acids, as well as components alcohol, linoleyl alcohol, behenylalcohol, lignoceryl alcohol, thereof, and combinations thereof. Fats occur widely in ceryl alcohol, capryl alcohol (1-octanol), capric alcohol organic tissue, particularly in the Subcutaneous connective (1-decanol, decyl alcohol), lauryl alcohol (dodecanol, tissue of animals (beef, poultry, pork, lamb, liver and the like), 1-dodecanol), myristyl alcohol (1-tetradecanol), cetyl alco and in the seeds, nuts and fruits of plants. There is generally hol (1-hexadecanol), palmitoleyl alcohol (cis-9-hexadecen no chemical difference between fats and oils, with the only 1-ol) and heptadecyl alcohol. Other fatty alcohols are known distinction being that fats are generally solid at room tem by those having ordinary skill in the art. perature and oils are generally liquid at room temperature. The term “firm' as is used herein means having a solid The phrase “fatty acids' as is used herein means carboxylic and/or compact structure that is partially or fully resistant to acids that generally are derived from, or contained in, an 10 stress or externally applied pressure. animal, vegetable or other fat or oil, whether Saturated, unsat The phrase “function effectively as is used herein means urated, monounsaturated, polyunsaturated, aromatic, essen that a base composition or active agent-containing composi tial, nonessential, in a cis- or trans-form, in the ethyl esters, mono-, di- or tri-glycerides, free fatty acids or other forms, tion of the invention has an ability to provide, produce or have and components and combinations of the foregoing. Fatty 15 one or more of the benefits and advantages that are described acids include, but are not limited to, the specific fatty acids herein for Such compositions, such as having an activity pro identified below: vided by an active ingredient present therein. The term "humans' as is used herein, unless otherwise stated, includes human beings that are babies, infants, chil dren or adults. Number of Number of The term “ingredient’ as is used herein interchangeably Common Name Carbon Atoms Double Bonds with “component' and "agent” in connection with composi Butyric Acid 4 O tions described herein. Caproic Acid 6 O The abbreviation “INCI as is used herein means Interna Caprylic Acid 8 O 25 tional Nomenclature Cosmetic Ingredient. Capric Acid 10 O Lauric Acid 12 O The term “lipid’ as is used herein means any of a group of Myristic Acid 14 O organic compounds, including fats, oils, waxes, sterols, and Palmitic Acid 16 O triglycerides, that generally are insoluble in water but soluble Palmitoleic Acid 16 1 in nonpolar organic solvents, are oily to the touch, and Stearic Acid 18 O 30 Oleic Acid 18 1 together with carbohydrates and proteins constitute the prin Linoleic Acid 18 2 cipal structural material of living cells. Alpha-Linolenic Acid 18 3 The phrase “liquid” as is used herein means a state of (ALA) Gamma-Linolenic Acid 18 3 matter, neither Solid nor gas, in which a Substance exhibits a (GLA) characteristic readiness to flow, and the shape of which is Arachidic Acid 2O O 35 generally determined by the container that it fills. Gadoleic Acid 2O 1 The term “mammals' as is used herein includes humans Arachidonic Acid (AA) 2O 4 Eicosapentaenoic Acid 2O 5 and non-human mammals, such as animals (dogs, cats, (EPA) horses, cows, bulls, pigs, goats, sheep, birds, fowl, or the Behenic Acid 22 O like)). Erucic Acid 22 1 40 The phrase “marine oil” as is used herein includes, but is Docosahexaenoic Acid 22 6 not limited to, “fish oil and one or more individual compo Lignoceric Acid 24 O nents of marine oil. Such as an omega-3 fatty acid, or a combination thereof. Marine oils include, for example, her Other fatty acids are known by those of skill in the art. A wide ring oil, cod oil, anchovy oil, tuna oil, Sardine oil, menhaden variety offatty acids are commercially available from sources 45 oil and algae oil. known by those of skill in the art. Also, oils can be separated The phrase “mucosal membrane' as is used herein means a into their component fatty acids on a capillary column in a gas membrane that lines a body passage that communicate with chromatograph, and the relative fatty acid contents measured. the air, Such as the respiratory and alimentary tracts, and Additional information concerning fatty acids is readily which may have cells and/or associated glands that secrete available from the Fatty Acid Producer's Council (New York, 50 CS. N.Y.). The phrase “Natunola Castor 1023 as is used herein The phrase “fatty alcohol as is used herein means an means a Substance that consists of, or contains, castor oil, alcohol that is derived from a fat or oil, which may originate glycerine Soybean germ extract, corn starch and silica. Its in a plant or plant part, but may also be synthesized in an INCI name is Ricinus Communis (Castor) Seed Oil (and) animal or in algae or the like. Fatty alcohols are often closely 55 Glycine Soia (Soybean) Germ Extract (and) Zea Mays (Corn) related to fatty acids, including omega-3 fatty acids. They Starch (and) Silica.). It is commercially available from often have an even number of carbon atoms, and production Sources that are known by those having ordinary skill in the from fatty acids generally yields normal-chain alcohols, in art, for example, from Natunola Health Biosciences, Inc. which the alcohol group (-OH) attaches to the terminal (Winchester, Ontario, Canada) or Natunola Health, Inc. carbon atom. Other processing can yield iso-alcohols, in 60 (Winchester, Ontario, Canada). which the alcohol attaches to a carbon atom located in the The term “non-OTC as is used herein in connection with interior of the carbon chain. Fatty alcohols include normal a topical skin composition means that the composition typi chain alcohols, Saturated alcohols, unsaturated alcohols, cally would not be regulated in the U.S. by the U.S. Federal acetylenic alcohols, Sulfated alcohols, branched chain alco Drug Administration (FDA), or by its statutes, regulations hols and/or the like. Examples of some specific fatty alcohols 65 and rules. Compositions of the invention that do not include include, but are not limited to, stearyl alcohol (1-octade any active ingredients, such as hydrocortisone, would gener canol), isoStearyl alcohol (16-methylheptadecan-1-ol), oleyl ally be classified as “non-OTC compositions. US 8,685,381 B2 37 38 The term “oil” as is used herein means a fat that generally castor oil, may be varied in a manner desired or required to is viscous, liquid or liquefiable at room temperature, and cause the weight percent of the composition to be 100%. includes mixtures and other combinations of one or more oils The phrase “room temperature' as is used herein means the and/or components of oils, such as fatty acids, glycerides temperature in a room, which generally ranges from about and/or ethyl esters of fatty acids (or components thereof). 15° C. to about 30° C. (from about 59° F to about 86°F), and The phrase "on a regular basis' as is used herein means that more usually ranges from about 21°C. to about 23°C. (from a composition employed in the methods of the invention is about 70° F. to about 74°F). The “ambient temperature” of a applied to the skin of a mammal on a reasonably continuous room is “room temperature.” basis (i.e. without delaying one or more applications for an The phrase “safe for use as is used herein in connection unreasonably lengthy period of time), for example, a regular 10 with compositions described herein, and methods of the application of the composition to the mammal’s skin one, invention, means that the compositions, and the components two, three, four, five, six, seven, eight, nine, ten and so forth contained therein, and the methods, using reasonable quanti times within a period of one, two, three, four, five, six, seven, ties of active and other components, and administered for eight, nine, ten and so forth days for a duration of one, two, reasonable periods of time (such as those quantities and peri three, four, five, six, seven, eight, nine, ten and so forth days 15 ods of time described herein, or as otherwise recommended or weeks. for a particular mammal by a physician, Veterinarian or other The abbreviation “OTC as is used herein in connection skilled clinician), which may vary for different types of mam with a topical skin composition means that the composition mals, do not cause, or present an unreasonable risk of harm, typically would be regulated in the U.S. by the U.S. Federal damage, defect, disorder, deformity or injury to, or by, an Drug average mammal, or the skin of an average mammal, whether Administration (FDA), and its statutes, regulations and/or or not the mammal has one or more skin disorders, diseases, rules, such as the Federal Food, Drug and Cosmetics Act, conditions or maladies. which is hereby incorporated herein in its entirety by refer The phrase “semi-solidas is used herein means a state of ence along with its associated regulations and rules. For matter that is intermediate in properties, especially in rigidity, example, compositions of the invention that include an active 25 firmness and compactness, between a solid and a liquid. Such ingredient, such as hydrocortisone, would generally be clas as a gel, a cream, an ointment and/or the like. A semi-solid sified as “OTC compositions. The phrase “plant seed oil as composition is typically not rigid, compact or firm. Unlike a is used herein means an oil that is extracted, or otherwise Solid composition, a user may insert a finger into a pot con obtained from, either directly or indirectly, a seed of a plant, taining a semi-solid composition, such as petroleum jelly, and particularly oily seeds, including one or more individual com 30 scoop a portion of it out with the finger. ponents thereof and mixtures thereof. Plant seed oils include, The term “shape’ as is used herein in connection with base but are not limited to, Black Currant seed oil, Borage seed oil, compositions and active agent-containing compositions safflower seed oil, sunflower seed oil, sesame seed oil, avo includes, but is not limited to, any of a wide variety of known cado seed oil, pumpkin seed oil, olive seed oil, coconut seed or unknown shapes of any desired or required size, such as oil, rapeseed oil, flaxseed (linseed) oil, cottonseed oil, tung 35 circular or oval spheres, square or rectangular cubes or oil, meadowfoam seed oil, parsley seed oil, carrot seed oil, prisms, triangular prisms, square-based pyramids, triangle fennel fruit oil, parsnip seed oil, coriander seed oil, chervil based pyramids, cuboid hexagonal prisms, cones, cylinders seed oil, caraway plant oil, celery seed oil and others that are and/or the like. The shaped of a “stick” as is referred to herein described herein. Other plant seed oils are known by those means a cylinder. The sizes of Such shapes (length, width, having ordinary skill in the art. 40 depth and/or the like) may be any size that is desired, conve The phrase “plant oil as is used herein means an oil that is nient for use or required including, but not limited to, from extracted, or otherwise obtained from, either directly or indi one or a plurality of mm (or Smaller) to one or a plurality of rectly, a plant, particularly an oily plant, including one or inches or feet. Two cylinder-shaped active-agent containing more individual components thereof, and mixtures thereof. compositions, having two very different sizes, are shown in Plant oils include, but are not limited to, Evening Primrose 45 FIG 1. oil, Borage oil, safflower oil, sunflower oil, peanut oil, walnut The term "skin' as is used herein in connection with human oil, almond oil, avocado oil, olive oil, corn oil, Soy oil, Soy beings means the outer integument or covering of the body, bean oil, coconut oil, palm oil, palm kernel oil, castor oil, containing multiple layers, including the epidermis (outer mineral oil and others that are described herein. Other plant most layer, which typically ranges from about 0.5 to about 1.5 oils are known by those having ordinary skill in the art. 50 mm in thickness), which itself includes the five layers (from The term “pliable' as is used herein means supple enough bottom to top) of the stratum basale, stratum spinosum, Stra to partially (greater than about 0% but less than about 100%) tum granulosurn, stratum licidum and stratum corneum, the or fully (about 100%) bend withoutbreaking. dermis (or cornium) (mid layer, which typically ranges from The term “plurality” as is used herein means more than about 0.3 to about 3.0 mm in thickness), which includes one. Such as two, three, four, five, six, seven, eight, nine, ten, 55 collagen tissue, elastic tissue and reticular fibers, and an eleven, twelve, thirteen, fourteen, fifteen, twenty, twenty upper papillar layer and a lower reticular layer, and Subcuta five, thirty, thirty-five and so forth. neous tissue (below the dermis). As it is used herein, skin The term “prescription” as is used herein means a written, includes, but is not limited to, the outer covering of the face telephonic or other order, typically made by a medical doctor (including the lips, eyelids and outer portions of the ears), (physician), for a preparation, distribution and/or administra 60 Scalp, neck, arms, legs, hands, feet, fingers, toes, chest, tion of a medicine or other treatment to a patient, or other breasts, back, abdomen, genitals and/or the like, and portions individual, for example, by a pharmacist or pharmacy. or parts thereof, of a human being or non-human mammal, The abbreviation “q.s” as is used herein means a sufficient Such as an animal. In connection with non-human mammals, quantity, for example, to cause the weight percent of a com the term “skin' includes the outer covering of the body that is position to be 100%, or to obtain a desired effect or benefit. 65 not fur, hair, feathers and/or the like. As it is used herein, the The plant or plant seed oil ingredient of the base and active term “skin' also includes inner areas or coverings of the body agent compositions of the invention, when present, Such as including, but not limited to, the inside of the nostrils of the US 8,685,381 B2 39 40 nose, the inside of the mouth, the inner ears, inside folds and but are not limited to, beeswax, lanolin, carnauba, candelilla, areas of female and male genitals, and all mucosal mem oZokerite, bayberry, Sugar cane, paraffin, microcrystalline branes. and sorbitol. The phrase “solid’ as is used herein means a state of matter, The phrase “weight percent as is used herein refers to the neither liquid nor gas, generally having a definite shape and percent weight, for example, of an ingredient that forms a part Volume, and typically being rigid, firm and/or compact in of a mixture, base composition, active-agent containing com Substance, but possibly having an ability to be pliable, and to position, other composition or the like, with the total weight be softened into a less firm and/or rigid state, or melt, upon of the mixture, base composition, active-agent containing heating it to a temperature that is above the melting point of composition or other composition or the like being 100 weight percent, and is a measure of the relative proportions of the solid (or to some other temperature that causes it to soften, two or more quantities in a mixture Thus, weight percent may which may be determined by those having ordinary skill in include any whole, partial, decimal or fractional number the art). A “solid composition is different from a “semi above 0, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, Solid composition, such as petroleum jelly, as a result of its 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, rigidness, firmness and/or compactness. For example, a user 15 33,34,35,36, 37,38, 39, 40, 41, 42, 43,44, 45,46, 47, 48,49, would typically have an ability to insert a finger into a 'semi 50, 51, 52,53,54, 55,56, 57,58, 59, 60, 61, 62,63, 64, 65,66, Solid composition present in a pot and Scoop a portion of the 67,68, 69,70, 71,72, 73,74, 75,76, 77,78, 79,80, 81, 82,83, composition out of the pot with the finger. The same user 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99 or typically would not have an ability to do the same with a 100 (or any amount in between the foregoing, Such as 1.1.1.2, “solid composition present in the same pot as a result of the 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9 and so forth). rigidity, firmness and/or compactness of the “solid compo The phrase “without significantly reducing the activities of sition. However, a “solid composition, as is described the active ingredients' as is used herein means that the active herein, may be transformed into a “semi-solid’ or “liquid agent(s) do not have a reduction in activity that is greater than state by applying heat to the “solid, causing the “solid’ to about 50 percent, and preferably that is not greater than about partially or fully melt, as is discussed herein (i.e., after the 25 40%, and more preferably that is not greater than about 30%, “solid product has been produced). and still more preferably that is not greater than about 20%, The phrases “surfactant and “wetting agents' as are used and even more preferably that is not greater than about 10%, herein mean Substances or agents that lower the Surface ten and still more preferably that is not greater than about 5% (out sion (tendency of a liquid to reduce its exposed surface to the of 100%). Thus, they have an activity ranging from about 30 50% to about 100%, which is preferably about 60% or higher, Smallest possible area) of a liquid, generally allowing easier more preferably about 70% or higher, still more preferably spreading, and/or the interfacial tension between two liquids. about 80% or higher, even more preferably about 90% or Surfactants are usually organic compounds that are amphip higher, and still more preferably about 95% or higher, and athic in that they contain both hydrophobic groups (their most preferably 100%. “tails”) and hydrophilic groups (their “heads'). Therefore, 35 The phrase “without significantly reducing the flavor of the they are typically sparingly soluble in both organic solvents flavorings' as is used herein means that the flavorings do not and water. Surfactants generally reduce the Surface tension of have a reduction in flavor that is greater than about 50 percent, water by adsorbing at the air-water interface, and reduce the and preferably that is not greater than about 40%, and more interfacial tension between oil and water by adsorbing at the preferably that is not greater than about 30%, and still more liquid-liquid interface. Many Surfactants can also assemble in 40 preferably that is not greater than about 20%, and even more the bulk Solution into aggregates that are known as micelles. preferably that is not greater than about 10%, and still more The phrases “topical administration.” “topically adminis preferably that is not greater than about 5% (out of 100%). tering and “topically applying as are used herein mean an Thus, they have a flavor capacity ranging from about 50% to application onto the skin (generally onto one or more exposed about 100%, which is preferably about 60% or higher, more or outer surfaces thereof, such as the outermost layer of the 45 preferably about 70% or higher, still more preferably about epidermis, which is exposed and visually observable), for 80% or higher, even more preferably about 90% or higher, example, using hands, fingers or a wide variety of applicators and still more preferably about 95% or higher, and most (roll-up, roll-on or other Stick container, tube container, cot preferably 100%. ton ball, powderpuff, Q-tip, pump, brush, mat, cloth and/or General Description and Advantages the like). The application may be made, for example, by 50 The present invention provides novel base compositions laying, placing, rubbing, Sweeping, pouring, spreading and/ and related topical active agent-containing compositions or massaging into, or onto, the skin, or by any other conve including hydrocortisone and/or one or a plurality of other nient or Suitable method. Compositions that may be applied active agents, which may be employed, for example, in an by topical administration include, but are not limited to, over-the-counter, prescription or other pharmaceutical prod Sticks, lipsticks, waxes, creams, lotions, ointments, balms, 55 uct for human beings or animals having one or a plurality of gels, glosses, Sunscreen preparations, cosmetics, masks, skin disorders, diseases or adverse conditions, or otherwise, leave-on washes or cleansers, depilatory preparations and/or and related methods of production and use. These composi the like. tions may be present in any Suitable, convenient and/or The term “viscosity’ as is used herein means resistance to desired form, including liquids, semi-solids and Solids in, for flow (of a fluid or semi-fluid). Viscosity can be measured 60 example, a cream, an ointment, a balm, a paste, a gel, a soft or using, for example, a commercially available viscometer. hard solid stick (roll-on, roll-up or otherwise), a form that The term “wax' as is used herein means a fatty substance sprays out of a can, and/or the like, but are preferably present that is often solid at room temperature and softens and melts in, and administered using, a roll-up, Solid, cylindrical when warmed. Generally, waxes are similarin composition to shaped Stick, such as the two such sticks that are illustrated in fats and oils, with the exception that they do not contain 65 FIG. 1, or a pot. glycerides. Some waxes are hydrocarbons, and others are The base and active agent-containing compositions of the esters offatty acids and alcohols. Examples of waxes include, invention have specific formulations including a unique com US 8,685,381 B2 41 42 bination of ingredients, and weight percents thereof which typically caused by hydrocortisone and/or other compo have Surprisingly and unexpectedly been determined via a sition ingredients (particularly active agent(s)), and odor significant amount of experimentation and testing on human to a user when applied to mucosal areas of the user's lips beings over a lengthy period of time to function extremely and/or elsewhere (i.e., it typically does not taste or Smell well together, providing topical active agent-containing skin bitter or otherwise unpleasant, and often tastes and compositions that are extremely efficacious for: (i) repairing, Smells good as a result of the base formulation and/or improving, partially (less than 100%) or fully (100%) heal flavorings masking, hiding, reducing or eliminating the ing, or otherwise treating a wide variety of different skin otherwise bitterness, bitter taste and/or smell and/or disorders, diseases, conditions, maladies, severe (or other) other unpleasant taste and/or Smell of the hydrocortisone dryness and/or the like, of the skin of mammals, when 10 (and/or other unpleasant tasting and/or Smelling active employed in the manner, and under the conditions, that are or inactive ingredient(s)), which is very unusual for described herein, including, but not limited to, inflammation, hydrocortisone-containing, and many other active ingre redness, itching, bumps, blisters, cuts, punctures, other dient-containing, topical skin compositions and prod wounds, cracking, severe dryness, allergic reactions, insect ucts); bites, microbes (various types of bacteria, viruses and/or the 15 (v) may be formed into a wide variety of different sizes like), trauma, irritant dermatitis, contact dermatitis, Sebor and/or shapes, or in multiple sizes and/or shapes (see, for rheic dermatitis, stasis dermatitis, perleche, psoriasis, example, FIG. 1), thereby permitting it to be topically eczema, eczema craquele, acne excoriee (a form or irritated applied to extremely small and extremely large areas of and/or picked acne), cheilitis, a variety of different skin com the skin; plications resulting from acne, Xerosis, disease related skin (vi) may be applied over various different body surface conditions and dryness from a variety of different medica areas of widely varying sizes and/or types, for example, tions, including, but not limited to, isotretinoin, acitretin, in a lip-based product for application to the lips, and also lipid-lowering agents and/or the like; and/or (ii) causing the in a separate product that is suitable for topical applica skin to feel less painful, less irritated, less Sore, less itchy, tion to larger body Surfaces, and, thus, permit a patient to more soothed, more softened and/or more conditioned (in 25 treat very Small and/or very large areas of the skin, with comparison with how the skin felt prior to a use of the com no limit in size of skin area to be treated (such as an area position(s)). that is a size of a pinpoint or Smaller and/or an area The base and active agent-containing compositions of the spanning one or a plurality of square inches or larger); invention have numerous very important benefits and advan (vii) are very convenient and easy to administer and deliver tages in the topical skin treatment field in comparison with 30 by users; other topical compositions for application to the skin, which (viii) are safe for use by human beings, animals and other often do not have such benefits and advantages, including mammals; hydrocortisone-containing topical compositions. Extremely (ix) are reliable for patients and other users with respect to advantageously, compositions within the invention typically: their healing effects (i.e., patients can expect to observe (i) penetrate one or a plurality of layers of a mammal’s skin 35 or detect an improvement of, or repair in, their skin or a including, for example, the epidermis and dermis, and complete healing thereof, as is discussed herein); the tissues present therein, thereby exhibiting effica (X) preferably, have a relatively solid consistency, being cious repair, improvement, healing, treatment and/or firm, rigid and/or compact, but preferably pliable, other beneficial actions in connection with a wide vari thereby allowing them to have longevity on the lips and ety of different skin disorders, diseases, adverse condi 40 other areas of the body to which they are topically tions and/or the like deep within the layers and/or tissues applied (i.e., they remain on those portions of the body of the skin, rather than only resting, laying or sitting on for relatively long periods of time, and typically longer top of the outside of the outermost layer of the mam periods of time in comparison with other Such products) mal's skin, as many other topical skin compositions do; and a good spreadability (i.e., they easily and readily (ii) provide a barrier on the surface of the skin that func 45 spread or slide on, over or across the skin); tions to seal the surface of the skin off from the outside (xi) do not easily or readily become removed from the skin environment, and reduce or prevent transepidermal of a user (by wiping, patting, rubbing, washing and/or water loss (TEWL) from the skin, thereby allowing the the like) after being applied topically thereto, rendering skin to retain moisture, and protecting the skin, which them more likely than products that easily or readily may already be damaged, injured or diseased, from one 50 become removed from the skinto repair, improve or heal or a plurality of adverse environmental and/or other the skin for a relatively long period of time, and to conditions (Sun, wind, very high or very low tempera protect the skin from adverse environmental and/or tures, precipitation, dirt, debris, and/or the like), thereby other conditions, as is discussed above; permitting the skin to be repaired, improve or fully heal (xii) maintain their consistency, form and/or shape (and while, at the same time, also preventing further or addi 55 typically all three) over relatively long periods of time, tional damage or injury (or other adverse effects) to the Such as one or a plurality of months or years, and under skin; relatively extreme environmental conditions, such as (iii) do not have an undesirable feel to the touch or skin of extremely hot and extremely cold temperatures (i.e., a mammal. Such as a very thick, verythin, tacky, Sticky, they typically do not melt at very high temperatures and greasy or gritty feel, but rather have a relatively smooth, 60 do not crack at very low temperatures), thereby render non-tacky, non-sticky, non-greasy, non-gritty and desir ing them to be extremely versatile and capable of use at able feel to the touch or skin of a mammal; virtually all temperatures, and in virtually all environ (iv) have no significant taste or odor, or have a pleasant or mental conditions, in which a user may be present or desirable taste, with minimal (typically about 20% or encounter, less, and preferably about 10% or less, and more pref 65 (xiii) remain physically and chemically stable over long erably about 5% or less) or none (0%) of the bitterness, periods of time. Such as a plurality of months or years, bitter taste or other unpleasant or undesirable taste that is and, thus, typically do not deteriorate, disintegrate or US 8,685,381 B2 43 44 otherwise breakdown, or the like, over time and produce tain their form, shape and consistency under very extreme a "gritty' consistency (i.e., including a plurality of rough heat and very extreme cold conditions, rendering them useful granules) or other undesirable consistency, as do many at virtually all temperatures and conditions that can be other topical skin compositions and products; endured by human beings, animals and other mammals, and (xiv) are cosmetically elegant and physically appealing and in a wide variety of climates, seasons and areas of the world. desirable in appearance to consumers; Base compositions and active agent-containing composi (XV) promote, encourage or otherwise enhance patient tions within the present invention, as well as their methods for compliance (as a result of the benefits described herein); production, have continuously been experimented with, and and/or improved, over a lengthy period of time. To date, numerous (xvi) are relatively inexpensive. 10 different formulations have been produced and experimen Most base and active agent-containing compositions of the tally tested. Those formulations that are referred to herein as invention possess each of the above benefits and advantages, “original were some of the initial formulations that were rendering them to be significantly more beneficial and advan prepared and experimentally tested, and those formulations tageous, and great improvements, in comparison with other that are referred to herein as “subsequent and/or “improved known (or other) topical skin compositions and products, 15 are later improved formulations that are more preferred than which typically do not have some or all of such benefits and the original formulations. The methods for production of advantages, including those that contain hydrocortisone. The these improved formulations, which are described herein in base and active agent-containing compositions of the inven detail, are also more preferred. tion, and related methods, have been determined via a signifi The improved formulations of the invention have been cant amount of experimentation and testing on human beings, determined, via a tremendous amount of experimentation as is discussed herein, and as is illustrated in FIGS. 2-17, to over a lengthy period of time, to have animproved (enhanced, typically be Superior (and often far Superior) in one or more of easier and better) slip (spreadability) on the skin of human the above characteristics (and often in all of these character beings, in comparison with the original formulations, permit istics) in comparison with similar and/or other known base ting them to slide and spread on the skin more easily and and other compositions, including those that contain hydro 25 rapidly, and coat the skin more fully and with more formula cortisone, in: (i) repairing, improving, healing or otherwise tion, regardless of their size or containment device (ar, pot, treating a wide variety of skin disorders, diseases, conditions, can, Squeezable tube, rigid tube, or the like), reducing, and maladies, dryness and/or the like; and/or (ii) causing the skin typically completely eliminating, any "skip' areas of the skin ofa user to experience a reduction in pain, Soreness, itching or (areas of the skinto be treated or coated with the compositions other discomfort or undesirable effect(s) and/oran increase in 30 that mistakenly or inappropriately do not become coated with Soothing, softness, conditioning and/or the like. Extremely the compositions, or do not have any of the compositions advantageously, more desirable, more pronounced and/or applied thereto), thereby providing a greater quantity of the more rapid positive results are typically achieved with the compositions to be applied to the skin, and a deeper absorp inventive compositions in comparison with other topical skin tion by, and penetration into, the various layers of the skin by compositions and products. 35 the compositions, and improved patient compliance with Also extremely advantageously, the base and active agent respect to their use of the compositions. These are all are very containing compositions of the invention generally have an beneficial characteristic for topically applied skin composi ability to maintaining their final form, shape and/or consis tions, and significant advantages and improvements in com tency (typically all three of them), Such as a relatively rigid, parison with known topical skin compositions (both over-the firm and compact, but preferably pliable, solid form, prefer 40 counter and prescription). ably in a cylinder (stick) shape under: (i) very high tempera Additionally, the improved formulations of the invention tures (i.e., temperatures up to about 50° C. (about 122°F) have an improved (enhanced or better) taste, Smell and/or and, in some cases, even up to about 60°C. (about 140°F), for texture (typically all three) in comparison with the original example, in the glove box of a 100° F. vehicle during the formulations, even when they do not include one or more Summer months in a Southern U.S. state; and (ii) very low 45 flavoring ingredients (as well as when they do), and when temperatures, such as on a ski slope in a northern U.S. state they include hydrocortisone. All of these compositions typi during the coldest months of a very cold winter, for example, cally have a better taste and Smell in comparison with known at temperatures below about 32° F (0° C.), and even below formulations including hydrocortisone. Such as CortiBalm lip about 0° F (-17.7° C.). Thus, in contrast with many other balm (Milan, Ind.), and other known formulations, which topical skin compositions, which often melt, decompose, dis 50 improves, promotes and encourages patient compliance. integrate, deteriorate, or otherwise breakdown or fall apart, or (Some active (or other) agents employed in topical skin com have some other adverse consistency, form and/or shape positions, for example, hydrocortisone, are known to produce change, often causing them to be or become very messy, or have an unpleasant taste and/or Smell, rendering them sloppy, Sticky, greasy, tacky, gritty and/or the like, particu undesirable for patients or other users to apply to their mouth larly at relatively high temperatures, the base and active 55 or face (or to other areas of their bodies).) agent-containing compositions of the invention, when Further, when present, or contained, in a pot or jar, users of presentina Solid form, Such as a stick, generally will not melt, the original formulations of the invention typically need to decompose, disintegrate, deteriorate, or otherwise break use their fingernails to scrape the formulations out of the pot down or fall apart, or become messy, sloppy, Sticky, greasy, or jar. Users do not need to do this with the improved formu tacky or gritty at these relatively high temperatures. This 60 lations of the invention, which is a benefit of these improved renders such base and active agent-containing compositions formulations in comparison with the original formations. of the invention extremely versatile, dependable and reliable. Moreover, the improved formulations of the invention may They typically have a melting point ranging from about 50° C. be used, and applied, more easily in "cold temperature' situ to about 60° C. (from about 122° F to about 140° F.), a ations and environments in comparison with the original for congealing point ranging from about 25°C. to about 30° C. 65 mulations. (from about 77°F to about 86°F), and no freezing point and, All base compositions and active agent-containing compo thus, very advantageously, typically have an ability to main sitions of the invention can be produced in a manner that US 8,685,381 B2 45 46 include, or do not include, one or more flavoring ingredients, extremely difficult to cause, or have, the ingredients thereof and that may be contained in a wide variety of different mix together properly, become evenly distributed within the containers, such as a squeezable or non-squeezable tube, a compositions, and form compositions having the beneficial pot, a jar, a can and/or the like, and in a Solid, semi-solid or characteristics that are described herein. As one example, it other form, Such as a small or large Solid stick. was found to be extremely difficult to include the ingredient The various ingredients present in the base compositions Natunola Castor 1023 in the compositions along with the and active agent-containing compositions of the present other ingredients present therein in a form of a solid. Such as invention, including hydrocortisone-containing composi a soft or hard Stick, and still have the Solid possess one or all tions, and related methods of production and use, are of the characteristics that are discussed herein, including an described in detail hereinbelow. They preferably do not 10 ability of the hydrocortisone (and/or other active agents) include any petroleum jelly (petrolatum), and if they do, the present therein to penetrate one or a plurality of the layers of amount of the petroleum jelly is generally in Small quantities, and/or tissues in, a mammal’s skin, and generally be effica generally less than about 5% by weight, and more preferably cious, and maintain its final form and shape, even when less than about 4% by weight, and still more preferably less present in extreme environmental conditions, such as freez than about 3% by weight, and still more preferably less than 15 ing, or elevated temperatures, and conditions in which users about 2% by weight, and even more preferably less than about may carry them on their person, or close to their bodies, and 1% by weight, and most preferably 0% by weight. They also exposed to body heat. preferably do not include any water, Surfactants, emulsifiers, As a result of the above, it was eventually determined that lidocaine hydrochloride, propylene glycol, aluminum fluo the base compositions and hydrocortisone- (and/or other ride (or combinations of aluminum and fluoride) or retinol (or active agent-) containing compositions typically should retinol derivatives or extracts). If they do include any of the include the ingredients that are described herein at the weight foregoing ingredients, each such ingredient is only generally percents indicated. When these compositions were produced present in very Small quantities, generally less than about without one or more of the required ingredients and/or using 2.5% by weight, and more preferably less than about 2% by different weight percents thereof, often a very undesirable weight, and still more preferably less than about 1.5% by 25 product resulted, which did not have component ingredients weight, and still more preferably less than about 1% by evenly distributed therein, which could not properly be weight, and even more preferably less than about 0.5% by applied to the skin of a human being, animal or other mam weight, and most preferably 0% by weight. mal, which would not penetrate one or a plurality of layers Hydrocortisone (and/or one or more other active agents) and/or tissues of the skin, which did not have an ability to functions as an active agent in the active agent-containing 30 maintain its shape and/or form under adverse environmental compositions of the invention, and the other ingredients conditions, and/or which did not have one or more of the other present therein typically collectively form a base, which func beneficial characteristics that are described herein. tions as a topical skin carrier vehicle for the hydrocortisone Base Composition (and/or other active agents) to be topically applied to the skin The novel base compositions that are described herein, of a human being, animal or other mammal. Most or all of the 35 which may be employed with hydrocortisone as an active components of the inventive base formulation function agent, or with one or a plurality of additional and/or different together as a blend to bind the various components in the active ingredients, have surprisingly and unexpectedly been hydrocortisone (and/or other active agent-containing) formu determined via a significant amount of testing and experi lation together in a manner that enables it to be easily, readily, mentation over a lengthy period of time to be particularly Smoothly and properly topically applied to the skin of a mam 40 effective as a carrier vehicle for topically applied active mal, and to penetrate one or a plurality of layers of the skin agents, such as hydrocortisone (and many other active (usually several or all of them), and/or one or more of the agents). Its unique formulation of ingredients, and particular tissues present therein. This permits the hydrocortisone (and/ weight percents thereof in the formulation, has been found to or other active agent) to exhibit its healing and/or other ben be particularly effective in promoting or causing a penetration eficial effects internally and deeply within the structure of the 45 of the active agents(s), along with the base composition, deep skin, and in significantly deeper areas, tissues and/or layers of within one or more of the various layers and tissues of the the skin than only the top layer (rather than only sitting, skin, including the dermis and epidermis, and maintaining resting or laying on the outermost area of the outermost layer their consistency, form and/or shape (usually all three). Such of the skin, with no or little penetrating action, as is the case as a solid stick, during extreme environmental conditions, with many other topical skin compositions, including those 50 such as extreme heat or cold. Many other base formulations containing hydrocortisone). As a result, extremely advanta very disadvantageously tend to melt and become liquid-like, geously, the hydrocortisone (and/or other active agent) messy and/or sloppy during relatively high temperature con becomes absorbed and/or adsorbed deep into the various ditions, such as when left in a hot car during Summer months, layers and tissues present in the skin of a mammal to a sig potentially staining clothing and causing jewelry and other nificantly greater and/or deeper extent, and repairs, improves, 55 objects to become greasy and/or dirty. These novel base com heals and/or exhibits other beneficial effects in connection positions have been determined to be significantly more with, one or a plurality of internal layers of, and/or tissues effective for a topical delivery to the skin of humans beings, present in, the skin (as well as various areas of the uppermost, animals and/or other mammals of one or a plurality of active external, layer of the skin) in a significantly greater extent, in agents in comparison with other topically applied skin bases. comparison with other hydrocortisone- or active agent-con 60 The amounts of the various ingredients present in the base taining topical skin compositions, thereby promoting, and compositions of the invention may vary widely, depending generally providing, excellent skin repair, improvement, upon a variety of factors, such as the particular form and treatment and/or healing results. shape that the final topical formulation (including one or Via a significant amount of experimentation and testing more active agents) will have, for example, a Solid form, Such with the various ingredients of the base compositions of the 65 as a soft or hard Stick, a gel, a cream, an ointment and/or the invention, and with the hydrocortisone-containing and other like, the number and types of base ingredients that are compositions of the invention, it was determined to be employed, the number and types of active agents that are to be US 8,685,381 B2 47 48 employed, and/or the like, and may be determined by those or be present in a form of a Solid structure, or semi-solid having ordinary skill in the art using the information that is structure, for example, in the shape of a stick, or any another provided herein. shape desired or required, or present in a pot or jar. The base formulations of the invention (both original and Original Base Compositions 5 When none of the above-described optional base ingredi improved) include FANCOLVB, Natunola Castor 1023, Fin ents is present in the original base compositions, the amount solv TN and bees wax, and optionally one or a plurality of of Natunola Castor 1023 that is present in the original base plant oils, fatty alcohols, fats and flavorings, each in amounts compositions preferably ranges from about 23 to about 39 that are effective for forming a base having an ability to act weight percent, and more preferably ranges from about 26 to effectively as a topical carrier vehicle upon the skin or human about 35 weight percent (with the total base compositions beings, animals and/or other mammals for one or more active 10 having 100 percent weight). When, however, one or more of agents. Such as hydrocortisone, preferably in a form of a solid, Such optional base ingredients is present in the base compo Such as a stick, or semi-solid, and possessing one or more (or sitions, the amount of Natunola Castor 1023 that is present all) of the beneficial characteristics that are described herein. therein may be much less, such as about 16 weight percent (or In the improved base formulations (and active-agent formu possibly even lower, depending upon the number of optional lations), it is preferred that the base formulations include one 15 base ingredients included in the base compositions, and the or more plant oils, one or more fatty alcohols and one or more weight percents thereof), and preferably ranges from about 16 fats, as is discussed herein. Although each of the base ingre to about 20 weight percent, and more preferably ranges from dients is discussed in greater detail hereinbelow with respect about 17 to about 19 weight percent. to the compositions of the invention that include one or more Improved Base Compositions active agents, their weight percents in the base compositions The amount of Natunola Castor 1023 that is present in the of the invention are described directly below. improved base compositions of the invention preferably ranges from about 5 to about 39 weight percent, and more FANCOLVEB preferably ranges from about 5 to about 15 weight percent, and still more preferably ranges from about 9 to about 11 The amount of FANCOL VB that is present in the base 25 weight percent, and is most preferably about 10 weight per compositions is an amount that is effective to cause the base cent (whether or not any favoring ingredients are present in compositions to have one or more of the beneficial character the base compositions). istics that are described herein, such as causing, or aiding in Finsolv TN causing (generally in combination with one or more other ingredients). Such base compositions to properly form, or be 30 The amount of Finsolv TN that is present in the base present in a form of a solid or semi-solid structure, for compositions is an amount that is effective to cause the base example, in the shape of a stick, or any another shape desired compositions to have one or more of the beneficial character or required, or present in a pot or jar. istics that are described herein, Such as causing, or aiding in Original Base Compositions causing (possibly in combination with one or more other When none of the above-described optional base ingredi 35 ingredients). Such base compositions to function as an emol ents is present in the original base compositions, the amount lient upon the skin (i.e., to render or make the skin softer than of FANCOL VB that is present in the base compositions it would have been prior to applying the base compositions preferably ranges from about 13 to about 25 weight percent, thereto). and more preferably ranges from about 16 to about 22 weight Original Base Compositions percent (with the total base compositions having 100 percent 40 When none of the above-described optional base ingredi weight). When, however, one or more of such optional base ents is present in the original base compositions, the amount ingredients is present in the original base compositions, the of Finsolv TN that is present in the original base compositions preferably ranges from about 13 to about 25 weight percent, amount of FANCOLVB that is present therein may be much and more preferably ranges from about 16 to about 22 weight less, Such as about 9 weight percent (or possibly even lower, percent (with the total base compositions having 100 percent depending upon the number of optional base ingredients 45 weight). When, however, one or more of such optional base included in the base compositions, and the weight percents ingredients is present in the base compositions, the amount of thereof), and preferably ranges from about 9 to about 13 Finsolv TN that is present therein may be much less, such as weight percent, and more preferably ranges from about 10 to about 9 weight percent (or possibly even lower, depending about 12 weight percent. upon the number of optional base ingredients included in the Improved Base Compositions 50 base compositions, and the weight percents thereof), and The amount of FANCOL VB that is present in the preferably ranges from about 9 to about 13 weight percent, improved base compositions of the invention preferably and more preferably ranges from about 10 to about 12 weight ranges from about 6 to about 25 weight percent, and more percent. preferably ranges from about 6 to about 16 weight percent, Improved Base Compositions and still more preferably ranges from about 10 to about 12 55 The amount of Finsolv TN that is present in the improved weight percent, and is most preferably about 11 weight per base compositions of the invention preferably ranges from cent (whether or not any favoring ingredients are present in about 9 to about 25 weight percent, and more preferably the base compositions). ranges from about 10 to about 20 weight percent, and still more preferably ranges from about 14 to about 16 weight Natunola Castor 1023 60 percent, and is most preferably about 15 weight percent (whether or not any favoring ingredients are present in the The amount of Natunola Castor 1023 that is present in the base compositions). base compositions is an amount that is effective to cause the base compositions to have one or more of the beneficial Bees Wax characteristics that are described herein, such as causing, or 65 aiding in causing (generally in combination with one or more The amount of bees wax that is present in the base compo other ingredients). Such base compositions to properly form, sitions is an amount that is effective to cause the base com US 8,685,381 B2 49 50 positions to have one or more of the beneficial characteristics described herein, Such as causing, or aiding in causing (pos that are described herein, Such as causing, or aiding in causing sibly in combination with one or more other ingredients), (generally in combination with one or more other ingredi Such base compositions to function as an emollient upon the ents), Such base compositions to properly form, or be present skin (i.e., to render the skin softer than it would have been in a form of a solid structure, or semi-solid structure, for 5 prior to applying the base compositions thereto). example, in the shape of a stick, or any another shape desired Original Base Compositions or required, or present in a pot or jar. When present in the original base compositions, the plant Original Base Compositions oil(s) and/or plant seed oil(s), Such as castor oil, preferably is When none of the above-described optional base ingredi present in the base compositions in an amount (combined) ents is present in the original base compositions, the amount 10 preferably ranging from about 0.1 to about 24 weight percent, of bees wax that is present in the original base compositions and more preferably ranging from about 8 to about 17 weight preferably ranges from about 26 to about 43 weight percent, percent, and most preferably ranging from about 10 to about and more preferably ranges from about 29 to about 39 weight 15 weight percent. percent (with the total base compositions having 100 percent Improved Base Compositions weight). When, however, one or more of such optional base 15 When present in the improved base compositions, the plant ingredients is present in the base compositions, the amount of oil(s) and/or plant seed oil(s), Such as castor oil, preferably is bees wax that is present therein may be much less, Such as present in the base compositions in an amount (combined) about 18 weight percent (or possibly even lower, depending preferably ranging from about 0.1 to about 38.5 (from about upon the number of optional base ingredients included in the 0.1 to about 38.0 if one or more flavoring ingredients are base compositions, and the weight percents thereof), and present) weight percent, and more preferably ranging from preferably ranges from about 18 to about 22 weight percent, about 13.5 to about 38.5 (from about 13 to about 38 if one or and more preferably ranges from about 19 to about 21 weight more flavoring ingredients are present) weight percent, and percent. still more preferably ranging from about 25 to about 27 (from Improved Base Compositions about 24.50 to about 26.50 if one or more flavoring ingredi The amount of bees wax that is present in the improved 25 ents are present), and is most preferably about 26 (about 25.5 base compositions of the invention preferably ranges from if one or more flavoring ingredients are present) weight per about 6 to about 43 weight percent, and more preferably Cent. ranges from about 6 to about 16 weight percent, and still more preferably ranges from about 10 to about 12 weight percent, Fatty Alcohols and is most preferably about 11 weight percent (whether or 30 not any favoring ingredients are present in the base compo The amount (combined) of one or more fatty alcohols that sitions). is present in the base compositions is an amount that is effec When only FANCOLVB, Natunola Castor 1023, Finsolv tive to cause the base compositions to have one or more of the TN and bees wax are present in the base composition, and it beneficial characteristics that are described herein, such as is desired to form a solid stick form of the base composition 35 causing, or aiding in causing (generally in combination with as a topical carrier vehicle for one or more active ingredients, one or more other ingredients). Such base compositions to preferred base compositions of the invention includes the properly form, or be present in a form of a solid structure, or weight percents identified below (out of 100 weight percent semi-solid structure, for example, in the shape of a stick, or for the total base) for these four ingredients. any another shape desired or required, or present in a pot or 40 Jar. Original Base Compositions When present in the original base compositions, the fatty Ingredient Weight Percent alcohol(s), Such as Stearyl alcohol, preferably is present in the base compositions in an amount (combined) preferably rang FANCOLVEB 18.333 45 Natunola Castor 1023 3O.OOO ing from about 0.1 to about 22 weight percent, and more Finsolv TN 18.333 preferably ranging from about 10 to about 22 weight percent, BeeSWax 33.334 and most preferably ranging from about 18 to about 22 weight percent. TOTAL 1OO Improved Base Compositions 50 When present in the improved base compositions, the fatty The original and improved base formulations of the present alcohol(s), Such as Stearyl alcohol, preferably is present in the invention optionally (i.e., the weight percent may be 0%), but base compositions in an amount (combined) preferably rang preferably, also include one or a plurality of plant and/or plant ing from about 0.1 to about 25 weight percent, and more seed oils, such as castor oil, one or a plurality offatty alcohols, preferably ranging from about 15 to about 25 weight percent, Such as Stearyl alcohol, one or a plurality offats, such as cocoa 55 and still more preferably ranging from about 19 to about 21 butter, and/or one or a plurality of flavorings, such as Vanilla weight percent, and is most preferably about 20 weight per flavoring (and preferably all of them). They, and the compo cent (whether or not any favoring ingredients are present in sitions of the invention that include one or more active ingre the base compositions). dients, may also optionally include a variety of other ingre dients, as is discussed hereinbelow. 60 Fats Plant and Plant Seed Oils The amount (combined) of one or more fats that is present in the base compositions is an amount that is effective to cause The amount (combined) of one or more plant oils or plant the base compositions to have one or more of the beneficial seed oils that are present in the base compositions is an 65 characteristics that are described herein, such as causing, or amount that is effective to cause the base compositions to aiding in causing (generally in combination with one or more have one or more of the beneficial characteristics that are other ingredients). Such base compositions to properly form, US 8,685,381 B2 51 52 or be present in a form of a Solid structure, or semi-solid patient being treated, the medical problem presented by the structure, for example, in the shape of a stick, or any another patient being treated, the particular active agent(s) to be shape desired or required, or present in a pot or jar. included in the formulation, whether the patient has any addi Original Base Compositions tional medical problems or concerns, and/or the like. The When present in the original base compositions, the fat(s), amount of the base composition employed is preferably an Such as cocoa butter, is preferably present in the base com amount that is effective for acting as a topically applied skin positions in an amount (combined) preferably ranging from carrier vehicle for the one or more active agents. Such amount about 0.1 to about 9 weight percent, and more preferably will generally be 100 weight percent (total weight of the ranging from about 4 to about 9 weight percent, and most composition) minus the total weight percent of the combined preferably ranging from about 6 to about 8 weight percent. 10 active agent(s), and typically ranges from about 80 to about Improved Base Compositions 99.9 weight percent, based upon the total weight of the com When present in the improved base compositions, the positions. Such an amount preferably ranges from about 95 to fat(s). Such as cocoa butter, preferably is present in the base about 99.9 weight percent, more preferably ranges from compositions in an amount (combined) preferably ranging about 97 to about 99 weight percent and most preferably from about 0.1 to about 12 weight percent, and more prefer 15 ranges from about 98 to about 99 weight percent. The ably ranging from about 2 to about 12 weight percent, and still amounts of the various ingredients that may be present in the more preferably ranging from about 6 to about 8 weight base composition may vary widely depending upon a variety percent, and is most preferably about 7 weight percent of factors, such as the number of ingredients that are (whether or not any favoring ingredients are present in the employed, the type of ingredients that are employed and the base compositions). like, and may readily be determined by those having ordinary skill in the art. Flavorings Three preferred base composition of the invention that may be employed with one or a plurality of active agents, such as The amount (combined) of one or more flavorings that is hydrocortisone, for forming a solid form thereof. Such as a present in the base compositions is an amount that is effective 25 to cause the base compositions to: (i) have a pleasant or Stick, and in the methods of the invention, contains the com desirable, or a specific, taste and/or odor, Such as a good ponents that are set forth below, and the exact or approximate Vanilla taste and odor; (ii) have no, a reduced, or a minimal, concentrations thereof (out of 100 weight percent for the total unpleasant taste and/or odor (in comparison with how the base). The first two base compositions include a flavoring taste and/or odor would have been if no flavoring(s) had been 30 (vanilla) and the third one does not. added); or (iii) have no taste and/or no odor. Original Base Compositions Original Base Compositions When present in the original base compositions, the flavor ing(s), such as Vanilla flavorings, are present in an amount (combined) preferably ranging from about 0.1 to about 3.5 35 weight percent, and more preferably ranging from about 0.2 Ingredient Weight Percent to about 3 weight percent, and most preferably ranging from FANCOLVEB 11111 about 0.4 to about 1 weight percent. Natunola Castor 1023 18.181 Improved Base Compositions FINSOLVTN 11111 When present in the improved base compositions, the fla 40 BeeSWax 20.2O2 Voring(s). Such as Vanilla flavorings, preferably is present in Castor Oil 11.616 Stearyl Alcohol 20.2O2 the base compositions in an amount (combined) preferably Cocoa Butter 7.070 ranging from about 0.1 to about 3.5 weight percent, and more Flavor O.S13 preferably ranging from about 0.1 to about 2.5 weight per cent, and still more preferably ranging from about 0.3 to about 45 TOTAL 100 1.5 weight percent, and is most preferably about 0.5 weight percent. The inventive base compositions are described herein as a carrier vehicle for hydrocortisone, but may be used with a wide variety of other, or additional, topically applied active 50 Ingredient Weight Percent agents, such as are described herein. FANCOLVEB 11 Typically, one or a plurality of active agents will be com Natunola Castor 1023 18 bined with the base to form a composition for a topical appli FINSOLVTN 11 BeeSWax 2O cation to the skin of a mammal in a combined weight percent Castor Oil 12.5 (of the total weight of the compositions) that is effective for 55 Stearyl Alcohol 2O treating, healing (partially or fully) and/or repairing the skin Cocoa Butter 7 of mammals with respect to a wide variety of different disor Flavoring O.S ders, diseases and/or conditions, such as those that are described herein, or others, and/or causing the skin to feel TOTAL 100 more soothed, softened and/or conditioned that in did prior to 60 a use of the active agent-containing compositions. The base composition (combination of base ingredients) will typically form the remaining weight percent of the composition. The amount of a base composition of the invention that is Ingredient Weight Percent included in a topical active-agent containing skin formulation 65 FANCOLVEB 11 of the invention may vary widely, depending upon a variety of Natunola Castor 1023 18 factors, such as the age, gender, weight and condition of the US 8,685,381 B2 54 -continued are pharmaceutical grade products. Hydrocortisone is, at present, typically only available as a lotion, cream, ointment Ingredient Weight Percent and in one semi-solid balm product that is specifically FINSOLVTN 11 designed, and marketed for, the lips. BeeSWax 2O Hydrocortisone ((11B)-11, 17.21-trihydroxypregn-4-ene Castor Oil 13 Stearyl Alcohol 2O 3.20-dione) has the chemical formula CHOs, and the Cocoa Butter 7 chemical structure that is shown below, and is the primary steroid hormone or glucocorticoid that is produced by the TOTAL 100 adrenal cortex of the adrenal gland. 10

Improved Base Compositions

15

Ingredient Weight Percent FANCOLVEB 11.00 Natunola Castor 1023 1O.OO FINSOLVTN 1S.OO BeeSWax 11.00 Castor Oil 25.50 Stearyl Alcohol 2O.OO Hydrocortisone is generally released by the body in response Cocoa Butter 7.00 Flavoring (Vanilla) OSO to stress and to a low level of blood glucocorticoids, and its 25 primary functions are to suppress the immune system, TOTAL 1OO increase blood Sugar through gluconeogenesis and aid in fat, protein and carbohydrate metabolism. Various synthetic and other forms of hydrocortisone may be used to treat a variety of different disorders, diseases, 30 adverse conditions and/or illnesses, either as an injection or Ingredient Weight Percent topically, for example, in a treatment of inflammation, red FANCOLVEB 11.00 ness, allergy, itching, collagen diseases, asthma, adrenocor Natunola Castor 1023 1O.OO tical deficiency, shock, and Some neoplastic conditions. FINSOLVTN 1S.OO When applied topically to the skin, hydrocortisone often BeeSWax 11.00 35 reduces or terminates the actions of various chemicals in the Castor Oil 26.00 bodies of human and non-human mammals that cause inflam Stearyl Alcohol 2O.OO Cocoa Butter 7.00 mation, redness, Swelling, blisters, itching and/or the like. It is Flavoring (Vanilla) O.OO useful for treating and healing one or a plurality of disorders of the skin, which may be caused by a number of different TOTAL 1OO 40 conditions or factors, including, but not limited to, a wide variety of skin inflammatory conditions, redness, Swelling, Compositions Including Active Agent(s) blisters, burns, cuts, punctures (and other skin perforations), The various ingredients of compositions within the inven bug bites, razor bumps, chronic (or other) dermatitis, irritant tion that include one or a plurality of active agents, such as dermatitis, contact dermatitis, seborrheic dermatitis, Stasis hydrocortisone, alone or in combination with one or more 45 dermatitis, acne excoriee, many skin complications resulting other active agents, the weight percents thereof, and preferred from acne, allergic reactions, insect bites, trauma, perleche, compositions of the invention, are discussed below. eczema, eczema craquele, psoriasis, Xerosis, genital skin dis orders, poison ivy, poison oak, general itching, a presence of Hydrocortisone and/or other Active Ingredients) microbes (bacteria, viruses, and/or the like), disease related 50 skin conditions and dryness from medications such as isotre Hydrocortisone (also known as Cortisol) is employed in tinoin, acitretin and lipid lowering agents, and/or the like. topical compositions within the invention as an active agent to Hydrocortisone USP (United States Pharmacopeia), and repair (partially—from more than 0% to less than 100%, and other forms of hydrocortisone, are commercially available preferably fully—about 100%), improve, heal (partially— from sources that are known by those having ordinary skill in from more than 0% to less than 100%, and preferably fully— 55 the art, for example, from Spectrum Chemical Mfg. Corp. about 100%) and/or treat the various skin disorders, diseases (Gardena, Calif.) and Pfizer CentreSource (Kalamazoo, and adverse conditions that are described herein, as well as Mich.). others, and/or to cause the skinto feel more soothed, softened The amount (combined) of the one or more active agents, and/or conditioned than prior to a use of the active agent, Such as hydrocortisone (alone or in combination with one or either as a sole active agent or alone, or in combination, with 60 more other active agents), that may be employed in the active one or a plurality of other active ingredients, and either in a agent-compositions of the present invention is an amount that pure form or in one or more various known (or other) syn is effective, when present in a base composition described thetic, derivative or combination forms, which are known by herein, to promote, encourage or cause apartial or total repair, those having ordinary skill in the art. These forms of hydro improvement, healing, treatment or other beneficial effect in cortisone are known under the umbrella of “topical corticos 65 connection with a skin disorder, disease, adverse condition, teroids.” and have different strengths and formulations, as are malady and/or the like, as they are discussed herein in detail known by those having ordinary skill in the art. Many of them (or otherwise). The amount (combined) of the one or more US 8,685,381 B2 55 56 active agents that is preferably incorporated into, or otherwise limited to, those that are identified below, and those that may formulated with, the base compositions of the invention will beinvented, developed and/or produced in the future, alone or generally be 100 weight percent (total weight of the compo in any combination (including all of the various and/or alter sition) minus the total weight percent of the base composition native chemical, brand, trade, generic and/or other names that (including all ingredients, and combined amounts thereof, 5 are, or may be, employed to identify each active ingredient, employed in the base composition). For the original active which are known by those having ordinary skill in the art). agent containing compositions of the invention, Such an Sources for these active ingredients are described herein and amount preferably ranges from about 0.1 to about 5 weight are known by those having ordinary skill in the art. percent, based upon the total weight of the compositions, and Topical Steroids more preferably ranges from about 0.5 to about 3 weight 10 Clobetasol propionate 0.05% (Dermovate) percent, and even more preferably ranges from about 0.8 to Betamethasone dipropionate 0.25% (Diprolene) about 2 weight percent, and most preferably is about 1 weight Halobetasol proprionate 0.05% (Ultravate) percent. For the improved active-agent containing composi Diflorasone diacetate 0.05% (Psorcon) tions of the invention, Such an amount preferably ranges from Fluocinonide 0.05% (Lidex) about 0.1 to about 5 weight percent, based upon the total 15 Halcinonide 0.05% (Halog) weight of the compositions, and more preferably ranges from Amcinonide 0.05% (Cyclocort) about 0.5 to about 3 weight percent, and even more preferably Desoximetasone 0.25% (Topicort) ranges from about 0.8 to about 2 weight percent, and still Triamcinolone acetonide 0.5% (Kenalog, Aristocort more preferably ranges from about 0.9 to about 1.5 weight cream) percent, and even more preferably ranges from about 0.95 to Mometasone furoate 0.1% (Elocon ointment) about 1.2 weight percent, and most preferably is about 1.0 Fluticasone propionate 0.005% (Cutivate) weight percent. Betamethasone dipropionate 0.05% (Diprosone) Additional information about hydrocortisone and/or its Fluocinolone acetonide 0.01-0.2% (Synalar, Synemol, uses is present in Hydrocortisone—A Medical Dictionary, Fluonid) Bibliography and Annotated Research Guide to Internet Ref. 25 Hydrocortisone Valerate 0.2% (Westcort) erences (ICON Health Publications, ISBN-10:0497005581, Hydrocortisone butyrate 0.1% (Locoid) 2004); Hydrocortisone: Webster's Timeline History, 1950 Flurandrenolide 0.05% (Cordran) 2007 (ICON Group International, Inc., ASIN: Triamcinolone acetonide 0.1% (Kenalog, Aristocort A B003N2ONFS, 2010); Hydrocortisone and Cortisone ointment) (Merck & Co., ASIN: B000GSVX48, 1956); and Francis D. 30 Mometasone furoate 0.1% (Elocon cream, lotion) W. Lukins, Medical Uses of Cortisone including Hydrocor Triamcinolone acetonide 0.1% (Kenalog, Aristocort tisone and Corticotropin (The Blakiston Company, ASIN: cream, lotion) B000SAR1OW, 1954). Fluticasone propionate 0.05% (Cultivate cream) One or a plurality of a wide variety of topical active ingre Desonide 0.05% (Tridesilon, DesOwen ointment) dients other than hydrocortisone, or in addition to hydrocor 35 Fluocinolone acetonide 0.025% (Synalar, Synemol cream) tisone, alone or in a combination with one or more other Hydrocortisone Valerate 0.2% (Westcort cream) active agents. Such as one or a plurality of steroids other than Prednicarbate 0.05% (Aclovate cream, ointment) hydrocortisone, antibiotics, antifungals, antihistamines, anti Triamcinolone acetonide 0.025% (Aristocort A cream, inflammatories, local anesthetics, anti-itch agents and/or the Kenalog lotion) like, may alternately, or additionally, be included in the 40 Fluocinolone acetonide 0.01% (Capex shampoo, Dermas active-agent containing topical compositions of the inven mooth) tion, and produced in the manner described herein, to treat, Desonide 0.05% (DesOwen cream, lotion) repair, improve and/or heal (fully or partially) a same or Hydrocortisone 2.5% (Hytone cream, lotion, ointment) similar, or different, skin disease, disorder, condition and/or Hydrocortisone 1% the like, and/or to provide one or a plurality of other (differ 45 Topical Antibiotics/Anti-Infectives ent) beneficial effects to the skin of a human being, animal Topical erythromycin (ATS and others) and/or other mammal. These active ingredients include, but Topical mupirocin (Bactroban) are not limited to, clindamycin (topical antibiotic), erythro Topical retapamulin (Altabax) mycin (topical antibiotic), neomycin (topical antibiotic), tre Topical bacitracin/polymyxin B (Polysporin) tinoin (topical retinoid), doxepin (topical antihistamine), flu 50 Topical bacitracin/neomycin/polymyxin B (Neosporin) randrenolide (topical corticosteroid), terbinafine (topical Topical Sulfacetamide Sodium/urea (Sulfa drugs) antifungal), permethrin (insecticide), malathion (insecticide), Topical Antifungals silver Sulfadiazine (antiseptic), Salicyclic acid (keratolytic), Natamycin and various herbal agents. The foregoing are only a few Rimocidin examples of the numerous different active agents that may be 55 Filipin employed in the compositions of the invention, alone or in Nystatin combination. Such active ingredients are known by those Amphotericin B having ordinary skill in the art, and also are described in Candicin Sources that are known by those having ordinary skill in the Hamycin art, such as in Maryadele J. O'Neil, The Merck Index, an 60 Miconazole, miconazole nitrate (Micatin) Encyclopedia of Chemicals, Drugs and Biologicals (Merck, Ketoconazole (NiZoral, Sebizole) 14th Edition, ISBN 091 191000X, 2006) and in PDR: The Clotrimazole (Lotriminm, Lotrimin AF, Canesten) Physician's Desk Reference 2010 (PDR Network, LLC, Econazole ISBN-10: 1563637480, 2009). Bifonazole Active ingredients that may be employed with, or in, the 65 Butoconazole base compositions of the invention, and in the active agent Fenticonazole containing compositions of the invention, include, but are not Isoconazole US 8,685,381 B2 57 58 Oxiconazole Topical Analgesics Sertaconazole (Ertaczo) Acetaminophen (Tylenol) Sulconazole Diclofenac (Cataflam, Voltaren) Tioconazole Diflunisal (Dolobid) Fluconazole Etodolac (Lodine, Lodine XL) Itraconazole Fenoprofen (Nalfon) IsaVuconazole Flurbiprofen (Ansaid) Ravuconazole Ibuprofen (Advil, Cramp End, Dolgesic, Excedrin IB, Posaconazole Genpril, Haltran, Ibren, Ibu, Ibuprin, Ibuprohm, Ibu Voriconazole 10 Tab, Medipren, Midol IB, Motrin, Nuprin, Pamprin-IB, Terconazole Q-Profen, Rufen, Trendar) Abafungin Indomethacin (Indocin, Indocin SR) Terbinafine (Lamisil) Ketoprofen (Actron, Orudis, Oruvail) Naftifine (Naftin) Ketorolac (Toradol) Butenafine (Lotrimin Ultra) 15 Meclofenamate (Meclomen) Anidulafungin Mefenamic Acid (Ponstel) Caspofungin Meloxicam (Mobic) Micafungin Nabumetone (Relafen) Polygodial Naproxen (Aleve, Anaprox. Anaprox DS, EC-Naprosyn, CiclopiroX, ciclopiroX olamine Naprelan, Naprosyn) Tolnaftate (Tinactin, Desenex. Aftate) Oxaprozin (Daypro) Undecylenic acid Phenylbutazone (Cotylbutazone) Flucytosine, 5-fluorocytosine Piroxicam (Feldene) Griseofulvin Sulindac (Clinoril) Haloprogin 25 Tolimetin (Tolectin, Tolectin DS) Sodium bicarbonate Celecoxib (Celebrex) Topical Immunomodulators Buprenorphine (Buprenex) Pimecrolimus 1% Cream (Elidel) Butorphanol (Stadol) Tacrolimus 0.1% ointment (Protopic) Codeine Topical Antihistamines 30 Hydrocodone Clemastine Hydromorphone (Dilaudid, Dilaudid-5, Dilaudid-HP. Diphenhydramine (Benadryl) Hydrostat IR) Doxylamine Levorphanol (Levo-Dromoran) Loratadine Meperidine (Demerol) Desloratadine 35 Methadone (Dolophine, Methadose) Fexofenadine Morphine (Astramorph PF, AVINZA, Duramorph, Kadian, Pheniramine MS Contin, MSIR, Oramorph SR, Rescudose, Roxanol) Cetirizine Nalbuphine (Nubain) Ebastine Oxycodone (OxyContin, Roxicodone) Promethazine 40 Oxymorphone (Numorphan) Chlorpheniramine Pentazocine (Talwin) Levocetirizine Propoxyphene (Cotanal-65, Darvon) Olopatadine Tramadol (Ultram) Quetiapine Tramadol and Acetaminophen (Ultracet) Meclizine 45 Butalbital, Acetaminophen, and Caffeine (Femcet, Dimenhydrinate Fioricet, Esgic, Esgic-Plus) embramine Butalbital, Aspirin, and Caffeine (Fiorinal) dimethindene Butalbital, acetaminophen, caffeine, and codeine (Fioricet dexchlorpheniramine with Codeine) Vitamin C (Ascorbic acid) 50 Hydrocodone and Ibuprofen (Hydrostal IR, Vicoprofen) Cimetidine Pentazocine/Naloxone (Talwin NX) Famotidine Acetaminophen and Codeine (Capital with Codeine, Mar Ranitidine gesic #3, Phenaphen with Codeine, Tylenol with Nizatidine Codeine) Roxatidine 55 Dihydrocodeine, Acetaminophen, and Caffeine (DHC Lafutidine plus) A-349,821 Hydrocodone and Acetaminophen (Allay, Anexsia 5/500, ABT-239 Anexsia 7.5/650, Dolacet, Dolagesic, Duocet, Ciproxifan Hycomed, Hydrocet, Hydrogesic, HY PHEN, Lorcet Clobenpropit 60 10/650, Lorcet-HD, Lortab, Panacet 5/500, Panlor, Thioperamide Stagesic, T-Gesic, Ugesic, Vicodin, Zydone) Thioperamide Oxycodone and Acetaminophen (Endocet, Percocet, Roxi JNJ 7777 120 cet, Roxilox, Tylox) VUF-60O2 Pentazocine and Acetaminophen (Talacen) Cromoglicate (Cromolyn) 65 Propoxyphene and Acetaminophen (Darvocet-N 50, Dar Nedocromil vocet-N 100, E-Lor, Propacet 100) B2 adrenergic agonists Aspirin, Caffein and Dihydrocodeine (Synalgos-DC) US 8,685,381 B2 59 60 Aspirin and Codeine (Empirin with Codeine) Tinosorb M (Bisoctrizole, Methylene Bis-Benzotriazolyl, Hydrocodone and Aspirin (Damason-P. Lortab ASA, Pana Tetramethylbutylphenol or MBBT) sal 5/500) Tinosorb S (Bis-ethylhexyloxyphenol methoxyphenol tri Oxycodone and Aspirin (Endodan, Percodan, Percodan azine, Bemotrizinol, BEMT or anisotriazine) Demi, Roxiprin) Neo Heliopan AP (Bisdisulizole Disodium, Disodiumphe Pentazocine and Aspirin (Talwin Compound) nyl dibenzimidazole tetrasulfonate, bisimidazylate or Propoxyphene, Aspirin, and Caffeine (Darvon Compound DPDT) 65, PC-Cap, Propoxyphene Compound 65) Mexoryl XL (Drometrizole Trisiloxane) Capsaicin (ArthriCare, ARTH-RX, AXsain, Capsagel, Benzophenone-9 (Uvinul DS 49, CAS 3121-60-6 or Dura-Patch, Methacin, Zotrix, Zotrix-HP) 10 Sodium Dihydroxy Dimethoxy Disulfobenzophenone) Benzocaine (Americaine, Endocaine, Lagol) Uvinul T 150 (Octyl triazone, ethylhexyl triazone or EHT) Benzocaine/Menthol (Benzocol, Butyl Aminobenzoate, Uvinul APlus (Diethylamino Hydroxybenzoyl Hexyl Ben Dermoplast) Zoate) Dibucaine (Cinchocaine, Nupercainal Cream, Nupercainal Uvasorb HEB (Iscotrizinol, Diethylhexylbutamido triaz Ointment) 15 one or DBT) Lidocaine (LidaMantle, Lidoderm, Lignocainem, Xylo Parsol SLX (Dimethico-diethylbenzalmalonate, Polysili calne) cone-15) Lidocaine/Prilocalne (EMLA) Isopentenyl-4-methoxycinnamate (Isoamyl p-Methoxy Topical Neurotoxins cinnamate, IMC, Neo Heliopan E 1000, Amiloxate) onabotulinumtoxin.A (Botox) abobotulinumtoxin.A (Dysport) FANCOLVEB incobotulinumtoxin.A (Xeomin) Botulinum Toxin Type A (Purtox) FANCOLVB (also known as FANCOL or Butyrospermum Topical Insect Repellents Parkii Butter Limnanthes Alba Seed Oil) is employed as a DEET (N,N-diethyl-m-toluamide) 25 base ingredient in the base compositions of the invention, and Essential Oil (Corymbia citriodora?p-menthane-3,8-diol in the topical active agent-containing compositions of the PMD) invention, and functions primarily to cause, or aid in causing Icaridin (Picaridin, Bayrepel, KBR 3023) (generally in combination with one or more other ingredi Nepetalactone (Catnip Oil) ents), such compositions to properly form, or be present in a Citronella oil 30 form of a solid or semi-solid structure (preferably a solid Permethrin Stick), but may also function to moisturize, condition and/or Neem oil protect the epidermal and/or other layers of the skin, to pro Bog Myrtle mote skin pigment wetting, skin penetration of active agents, IR 3535 (3-N-Butyl-N-acetyl-aminopropionic acid, spreadability on the skin, skinshine and/or binding of various ethyl ester) 35 composition ingredients together. Sunscreen Active Ingredients FANCOL VB consists of vegetable derived lipids and ste p-Aminobenzoic acid (PABA) rol enriched sheabutter extract. Its INCI name is Limnanthes Padimate O (OD-PABA, octyldimethyl-PABA or Alba (Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea O-PABA) Butter) Extract, and it preferably has the chemical and physi Phenylbenzimidazole sulfonic acid (Ensulizole, Eusolex 40 cal data shown below. 232, PBSA or Parsol HS) Cinoxate (2-Ethoxyethyl p-methoxycinnamate) Chemical and Physical Data Dioxybenzone (Benzophenone-8) Oxybenzone (Benzophenone-3, Eusolex 4360 or Escalol Color (Gardner) 3 max. 567) 45 Saponification Value 175 max. Homosalate (Homomethyl salicylate or HMS) Iodine Value 105 max. Menthyl anthranilate (Meradimate) Acid Value 0.5 max. Octocrylene (Eusolex OCR, 2-cyano-3.3diphenyl acrylic The solubility of FANCOLVB in various other ingredients or acid, or 2-ethylhexylester) compositions at both 25°C. and 75°C. is shown below. Octyl methoxycinnamate (Octinoxate, EMC, OMC, Eth 50 ylmethoxycinnamate, Escalol 557, 2-ethylhexyl Solubility of FANCOLVB at 25° C. and 75° C. paramethoxycinnamate or Parsol MCX) Octyl salicylate (Octisalate, 2-Ethylhexyl salicylate or Escalol 587) Sulisobenzone (2-Hydroxy-4-Methoxybenzophenone-5- 55 sulfonic acid, 3-benzoyl-4-hydroxy-6-methoxybenze Composition 25o C. 75o C. nesulfonic acid, BenZophenone-4 or Escalol 577) Castor Oil Soluble Soluble Trolamine salicylate (Triethanolamine salicylate) (Clear Solution) (Clear Solution) Avobenzone (1-(4-methoxyphenyl)-3-(4-tert-butylphe Mineral Oil Soluble Soluble (Clear Solution) (Clear Solution) nyl)propane-1,3-dione, Butyl methoxy dibenzoyl 60 Propylene Insoluble Insoluble methane, BMDBM, Parsol 1789 or Eusolex 9020) Glycol Ecamsule (Mexoryl SX or Terephthalylidene Dicamphor Glycerine Insoluble Insoluble Ethyl Soluble Soluble Sulfonic Acid) Acetate (Clear Solution) (Clear Solution) Titanium dioxide (CI77891) Ethyl Insoluble Soluble Zinc oxide 65 Alcohol (Clear Solution) 4-Methylbenzylidene camphor (Enzacamene, Parsol Water Insoluble Slightly Soluble 5000, Eusolex 6300 or MBC) US 8,685,381 B2 62 -continued primary component within Natunola Castor 1023, with the other components being glycerine Soybean germ extract, corn Composition 25o C. 75o C. starchand silica. It typically has the following characteristics: Isopropyl Soluble Soluble Myristate (Clear Solution) (Clear Solution) Characteristics Appearance: clear, transparent gel FANCOLVB is commercially available from sources that Odor: light, characteristic are known by those having ordinary skill in the art, for Solubility: soluble in all vegetable oils, glycerol tri-isos example, from The Fanning Corporation (Chicago, Ill.) or tearate, isostearyl isostearate, oleic acid, isostearic acid, Elementis Specialties, Inc. (Hightstown, N.J.). 10 coco-caprylate/caprate and mixed glycerides; insoluble in water silicone oil; partially soluble in ethanol and The amount of FANCOL VB that is present in the active 1.2propanediol agent-containing compositions of the invention is an amount pH (1:20 water emulsion): 4.6-6.6 that is effective to cause the compositions to have one or more Stability: Stable at room temperature of the beneficial characteristics that are described herein, such 15 Formulating pH: a pH range of from about 3 to about 8 is as causing, or aiding in causing (generally in combination preferred with one or more other ingredients). Such compositions to Formulating Temperature: a working temperature range of properly form, or be present in a form of a solid structure, or from about 45° C. to about 95°C. is preferred semi-solid structure, or example, in the shape of a solid stick Natunola Castor 1023 is commercially available from (i.e., cylinder shaped), or any another shape desired or Sources that are known by those having ordinary skill in the required, or present in a pot or jar. art, for example, from Natunola Health Biosciences, Inc. Original Active Agent-Containing Compositions (Winchester, Ontario, Canada) or Natunola Health, Inc. When none of the above-described optional base ingredi (Winchester, Ontario, Canada), or distributors or retailers ents is present in the original active agent-containing compo thereof, which are known by those having ordinary skill in the 25 art. sitions of the invention, the amount of FANCOL VB that is The amount of Natunola Castor 1023 that is present in the present in these compositions preferably ranges from about active agent-containing compositions of the invention is an 13 to about 25 weight percent, and more preferably ranges amount that is effective to cause the compositions to have one from about 16 to about 22 weight percent (with the total or more of the beneficial characteristics that are described compositions having 100 percent weight). When, however, herein, Such as causing, or aiding in causing (generally in one or more of Such optional base ingredients is present in 30 combination with one or more other ingredients). Such com these compositions, the amount of FANCOL VB that is positions to properly form, or be present in a form of a solid present therein may be much less, such as about 9 weight or semi-solid structure, for example, in the shape of a stick, or percent (or possibly even lower, depending upon the number in any another shape desired or required, or present in a pot or of optional base ingredients included in these compositions, Jar. and the weight percents thereof), and preferably ranges from 35 Original Active-Agent Containing Compositions about 9 to about 13 weight percent, and more preferably When none of the above-described optional base ingredi ranges from about 10 to about 12 weight percent. ents is present in the original active agent-containing compo Improved Active Agent-Containing Compositions sitions of the invention, the amount of Natunola Castor 1023 The amount of FANCOL VB that is present in the that is present in these compositions preferably ranges from improved active agent-containing compositions of the inven 40 about 23 to about 39 weight percent, and more preferably tion preferably ranges from about 6 to about 25 weight per ranges from about 26 to about 35 weight percent (with the cent, and more preferably ranges from about 6 to about 16 total compositions having 100 percent weight). When, how weight percent, and still more preferably ranges from about ever, one or more of Such optional base ingredients is present in these compositions, the amount of Natunola Castor 1023 10 to about 12 weight percent, and is most preferably about 11 that is present therein may be much less, Such as about 16 weight percent (whether or not any favoring ingredients are 45 weight percent (or possibly even lower, depending upon the present in the compositions). number of optional base ingredients included in these com Additional information about FANCOL VB is present at positions, and the weight percents thereof), and preferably the Elementis Specialties, Inc. Internet web site and at other ranges from about 16 to about 20 weight percent, and more web sites known by those having ordinary skill in the art. preferably ranges from about 17 to about 19 weight percent. 50 Improved Active Agent-Containing Compositions Natunola Castor 1023 The amount of Natunola Castor 1023 that is present in the improved active agent-containing compositions of the inven Natunola Castor 1023 (INCI name Ricinus Communis tion preferably ranges from about 5 to about 39 weight per (Castor) Seed Oil (and) Glycine Soja (Soybean) Germ. Extract cent, and more preferably ranges from about 5 to about 15 (and) Zea Mays (Corn) Starch (and) Silica,) is employed as a 55 weight percent, and still more preferably ranges from about 9 base ingredient in the compositions of the invention, and in to about 11 weight percent, and is most preferably about 10 the topical active agent-containing compositions of the inven weight percent (whether or not any favoring ingredients are tion. It functions primarily to cause, or aid in causing (gener present in the compositions). ally in combination with one or more other ingredients). Such Additional information about Natunola Castor 1023 is compositions to properly form, or be present in a form of a 60 present at a Natunola Health Biosciences, Inc. or Natunola solid or semi-solid structure (preferably a solid stick), but Health, Inc. Internet web site and at other web sites known by may also function to soften the skin and to bind various those having ordinary skill in the art. composition ingredients together, and typically resists oxida tion, and has a high degree of stability. Finsolv TN Natunola Castor 1023 is a glossy gel that is derived from 65 castor oil (ricinus communis) which, in turn, is derived from FinsolvTN (INCI name Cls Alkyl Benzoate, CAS Reg the bean of the Castor plant Ricinus communis, and is the istry Number 68411-27-8, EINECS Number 270-1,2-4, also US 8,685,381 B2 63 64 known as Finsolv) is employed as a base ingredient in the to about 13 weight percent, and more preferably ranges from compositions of the invention, and in the topical active agent about 10 to about 12 weight percent. containing compositions of the invention, and functions pri Improved Active Agent-Containing Compositions marily as an emollient, but may also function to as a binder (to The amount of Finsolv TN that is present in the improved bind composition ingredients together), a thickening agent, a 5 active agent-containing compositions of the invention pref dispersing aid and/or a lubricant therein. Cas Alkyl Ben erably ranges from about 9 to about 25 weight percent, and Zoate is the ester of benzoic acid and C-1s alcohols (q.v.). more preferably ranges from about 10 to about 20 weight and conforms to a formula below in which R represents a percent, and still more preferably ranges from about 14 to C12-1s alkyl group (C12, C1s, C14 and/or Cs): about 16 weight percent, and is most preferably about 15 10 weight percent (whether or not any favoring ingredients are present in the compositions). O Additional information about Finsolv TN is present at an Innospec Active Chemicals, LLC Internet web site and at C-OR. other web sites known by those having ordinary skill in the 15 art.

Finsolv TN is an emollientester that typically is non-toxic, Bees Wax non-irritating, non-sensitizing, waterinsoluble, readily emul Bees wax (also known as Cera alba and Cera flava) is sifiable and stable over a wide pH range, and has a high employed as a base ingredient in the compositions of the positive spreading coefficient. It typically has the following invention, and in the topical active agent-containing compo properties: sitions of the invention, and it functions primarily to cause, or aid in causing (generally in combination with one or more Properties other ingredients). Such compositions to properly form, or be 25 presentina form of a solid structure (preferably a solid stick), Appearance: clear, almost colorless liquid but may also function as a moisturizing agent, a softening Odor: very mild, and practically odorless agent, a thickening agent, an emollient (skin softener) and/or Boiling Point: 300° C. (572°F) a provider of skin protective action (of the nonoclusive type). Pour Point: 14°C. (approximately) It typically protects the skin from, for example, damaging Freezing Point Range: -3 to -12°C. 30 environmental factors, such as chemicals, adverse weather Flash Point: 163-166° C. conditions, and the like, by providing skin with a protective Specific Gravity at 25° C.: 0.928 coating against environmental elements. Bees wax permits, Refractive Index at 20° C.: 1.485 or helps permit, the compositions of the invention to be for Surface Tension at 15° C.: 31.5 dynes/cm mulated into a desired form and shape. Such as a stick that is Interfacial Tension in Water at 15° C.: 7.13 dynes/cm 35 soft, somewhat rigid or relatively hard (generally firm and/or Spreading Coefficient at 15° C.: 34.5 dynes/cm very rigid), such as a traditional ChapStick R form. It also Viscosity (Brookfield at 70° F., RV #1 Spindle, 100 RPM): functions as a binder (helping to bind all of the composition 38 cps ingredients together). Acidity (mg KOH/g): <0.10% Beeswax is generally a colorless, nutrient-rich, liquid lipid % Moisture: <0.10 40 that is secreted from special abdominal glands of honeybee, Finsolv TN is commercially available from sources that are Apis Mellifera, generally as they build honeycomb walls, and known by those having ordinary skill in the art, for example, transforms into a semi-solid Substance upon contact with the from Finetex, Inc. (Elmwood Park, N.J.) or Innospec Active atmosphere. It typically is non-allergenic and has water repel Chemicals, LLC (Edison, N.J.). lent properties, and may be purified from its raw state by The amount of Finsolv TN that is present in the active 45 freeing it of Solid impurities by melting and centrifugation. agent-containing compositions of the invention is an amount Bees wax typically contains from about 10 to about 15 per that is effective to cause the compositions to have one or more cent paraffin carbohydrates, from about 35 to about 37 per of the beneficial characteristics that are described herein, such cent esters of C to C fatty acids and about 15 percent as causing, or aiding in causing (possibly along with one or cerotic acid, melis sic acid and their homologues. Typically, more other ingredients). Such compositions to function as an 50 beeswax has a melting point of from about 62°C. to about 65° emollient upon the skin (i.e., to render the skin more soft than C., has an acid value of from about 17 to about 24, has a it would have been prior to applying the compositions saponification value of from about 89 to about 103, and has an thereto). ester value of from about 72 to about 79. Original Active-Agent Containing Compositions Bees wax is commercially available from sources that are When none of the above-described optional base ingredi 55 known by those having ordinary skill in the art, for example, ents is present in the original active agent-containing compo from Columbus Foods Company (Des Plaines, Ill.) or Hang sitions of the invention, the amount of Finsolv TN that is Zhou Golden Harvest Health Industry Co., Ltd. (Zhejiang, present in these compositions preferably ranges from about China). 13 to about 25 weight percent, and more preferably ranges The amount of beeswax that is present in the active agent from about 16 to about 22 weight percent (with the total 60 containing compositions of the invention is an amount that is compositions having 100 percent weight). When, however, effective to cause the compositions to have one or more of the one or more of Such optional base ingredients is present in beneficial characteristics that are described herein, such as these compositions, the amount of Finsolv TN that is present causing, or aiding in causing (generally in combination with therein may be much less, Such as about 9 weight percent (or one or more otheringredients). Such compositions to properly possibly even lower, depending upon the number of optional 65 form, or be present in a form of a Solid or semi-solid struc base ingredients included in these compositions, and the ture, for example, in the shape of a stick or any another shape weight percents thereof), and preferably ranges from about 9 desired or required, or present in a pot or jar. US 8,685,381 B2 65 66 Original Active-Agent Containing Compositions Costus Root Oil, Cranberry Seed Oil, Cumin Oil, Black Seed When none of the above-described optional base ingredi Oil, Curry Leaf Oil, Cypress Oil, Cypriol Oil, Dill Oil, Ele campane Oil, Elettaria Cardamomum (Cardamom) Seed Oil, ents is present in the original active agent-containing compo Emu Oil, Ethyl Ricinoleate Oil, Eucalyptus Globulus (Euca sitions of the invention, the amount of beeswax that is present lyptus) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, in these compositions preferably ranges from about 26 to 5 Evening Primrose Oil, Fennel Seed Oil, Fenugreek Oil, Fir about 43 weight percent, and more preferably ranges from Oil, Flax (Linseed) Oil, Florentine Iris (Iris Florentina) (Or about 29 to about 39 weight percent (with the total composi ris) Oil, Frankincense Oil, Galangal Oil, Galbanum Oil, Geranium Oil, Ginger Oil, Glyceryl Ricinoleate, Glyceryl tions having 100 percent weight). When, however, one or Ricinoleate Se, Glycol Ricinoleate, Goldenrod Oil, Grape more of Such optional base ingredients is present in these fruit Oil, Grapeseed Oil, Hazelnut Oil, Helichrysum Oil, compositions, the amount of bees wax that is present therein 10 Hemp Seed Oil, Henna Oil, Horseradish Oil, Hydrogenated may be much less, such as about 18 weight percent (or pos Castor Oil, Hyssop Oil, Idaho Tansy Oil, Illicium Verum sibly even lower, depending upon the number of optional base (Anise) Oil, Illipe Oil, Isopropyl Ricinoleate, Jasmine Oil, Jojoba Oil, Juniper Berry Oil, Kukui Nut Oil, Laurus Nobilis ingredients included in these compositions, and the weight Oil, Lavender Oil, Ledum Oil, Lemongrass Oil, Lime Oil, percents thereof), and preferably ranges from about 18 to 15 Litsea Cubeba Oil, Macadamia Nut Oil, Marjoram Oil, about 22 weight percent, and more preferably ranges from Meadowfoam Oil, Melaleuca Alternifolia (Tea Tree) Oil, about 19 to about 21 weight percent. Melissa Oil (Lemon Balm), Mentha Arvensis (Mint) Oil, Improved Active Agent-Containing Compositions Mentha Viridis (Spearmint) Leaf Oil, Methyl Ricinoleate, Mink Oil, Monoi De Tahiti, Mountain Savory Oil, Mugwort The amount of bees wax that is present in the improved Oil, Mustard Oil (Essential Oil), Myroxylon Pereirae (Bal active agent-containing compositions of the invention pref- 20 sam) Oil, Myrrh Oil, Myrtle Oil, Neem Oil, NeemTree Oil, erably ranges from about 6 to about 43 weight percent, and Neroli, Nutmeg Oil, Octyldodecyl Ricinoleate, Olive Oil, more preferably ranges from about 6 to about 16 weight Orange Oil, Oregano Oil, Palm Kernel Oil, Palm Oil, Palo percent, and still more preferably ranges from about 10 to Santo Oil, Parsley Oil, Patchouli Oil, Pennyroyal Oil, Pep about 12 weight percent, and is most preferably about 11 permint Oil, Perilla Essential Oil, Petitgrain Oil, Pimpinella weight percent (whether or not any favoring ingredients are 2s Anisum (Anise) Oil, Pine Oil, Piper Nigrum (Black Pepper) present in the compositions). Essential Oil, Plum Kernel Oil, Pomegranate Oil, Potassium Ricinoleate, Prunus Dulcis (Almond) Oil, PumpkinSeed Oil, Additional information about bees wax is present in, for Ravensara Oil, Red Cedar Oil, Red Palm Oil, Rice Bran Oil, example, Roger A. Morse et al., “Beeswax. Production, Har Ricinoleic Acid, Roman Chamomile Oil, Rosa Mosqueta vesting, Processing and Products” (Wicwas Pr, 1st Edition, (Rosehip) Oil, Rosa Rubiginosa (Rosehip) Oil, Rose Oil, ISBN-10: 1878075063, 1984); and Huber H. Root, “Bees- so Rosehip Seed Oil, Rosewood Oil, Rosmarinus Officinalis wax. Its Properties, Testing, Production and Applications' (Rosemary) Oil, Safflower Oil, Sage Oil, Sandalwood Oil, (Chemical Pub.Co., ASIN: B0007E742G, 1951). Sassafras Root Bark (Sassafras) Oil, Satureia Species (Sa vory) Oil, Schisandra Chinensis (Schisandra) Oil, Sesame Plant and Plant Seed Oils Oil, Shea Nut Oil, Sodium Ricinoleate Oil, Spearmint Oil, 35 Spice Star Anise (Star Anise) Oil, Spikenard Oil, Spruce Oil, One or a plurality of plant or plant seed oils (i.e., oils Sunflower Oil, Sweet Almond Oil, Tamanu Oil, Tanacetum procured or derived from one or more parts of a plant, shrub Balsamita (Costmary) Oil, Tangerine Oil, Thyme Oil, Tsuga or tree, such as a root, stem, bark, leaf, flower, seed, fruit Oil, Turmeric Oil, Valerian Oil, Vetiver Oil (Khus Oil), Vitis and/or the like) (or other similar oils) are optionally, but Winifera (Grape) Seed Oil, Walnut Oil, Western Red Cedar preferably, employed as a base ingredient in the base compo Oil, Wheat Germ. Oil, Wintergreen Oil, Yarrow Oil, Ylang sitions of the invention, and in the topical active agent-con 40 Ylang Oil, Zedoary Oil, Zinc Ricinoleate Oil, Zingiberaceae taining compositions of the invention, and functions prima (Ginger) (Cardamom Seed) Oil, and/or the like. rily as an emollient (skin softener), but may also function as a Castor Oil, which is the most preferred plant or plant seed lubricant and/or binder. Preferred plant or plant seed oils for oil for use in the base compositions and active agent-contain use in the base and active agent-containing compositions of ing compositions of the invention, is derived from the seeds of the invention include Castor Oil, Rice Brand Oil, Coconut 45 the Castor Oil plant, and typically consists of from about 87% Oil, Sunflower Oil and Olive Oil, with Castor Oil being the most preferred such oil, and is preferably present therein to about 90% ricinoleic acid (major component), about 7% (without other plant or plant seed oils). A wide variety of plant oleic acid, about 3% linoleic acid, about 2% palmitic acid and and plant seed oils are known by those having ordinary skill about 1% stearic acid. Most chemical and physical properties in the art and/or are described elsewhere herein and below. of Castor Oil are based on the molecular structure of ricino Plant and plant seed oils (or possibly fats in Some cases) 50 leic acid. that may be employed in the base and other compositions of the invention include, but are not limited to, Soybean Oil, Ricinoleic Acid Rapeseed Oil, Cottonseed Oil, Sunflower Seed Oil, Ground Nut Oil, Palm Oil, Palm Kernel Oil, Peanut Oil, Copra Oil, Sesame Oil, Sesame Seed Oil, Linseed Oil, Castor Oil, Maize 55 Oil, Coconut Oil, Olive Oil, Almond Oil, Coffee Oil, Costus Root Oil, Agarwood (Aquilaria Malaccensis)(Agar) Oil, Angelica Archangelica (Angelica Root) Oil, Apricot Kernel Oil, Artemisia Dracunculus (Tarragon) Oil, Artemisia Pal HO O lens (Davana) Oil, Asafoetida Oil, Avocado Oil, Babassu Oil, Basil Oil, Bay Oil, Bergamot Oil, Birch Oil, Borage Oil, 60 Buchu Shrub (Buchu) Oil, Calamus Root Oil, Calendula Oil, Camellia Oil, Camphor Oil, Cannabis Flower Essential Oil, Canola Oil, Caraway Oil, Carrot Seed Oil (Essential Oil), Carum Copticum (Ajwain) Oil, Cedarwood Oil, Cetyl Rinoleate, Chamomile Oil, Cinnamon Oil, Cistus Species 65 HO Oil, Citronella Oil, Clary Sage Oil, Clove Leaf Oil, Coconut Oil, Cocos Nucifera (Coconut) Oil, Coriander Oil, Corn Oil, US 8,685,381 B2 67 68 Castor oil, and other plant and plant seed (and other) oils, binding agent therein. The fatty alcohol often functions as a are commercially available from Sources that are known by bonding agent that binds, or helps bind, all of the ingredients those having ordinary skill in the art, for example, from Rita in the compositions together. Corporation (Crystal Lake, Ill.), Bulkoil.com (Greenbrae, Preferred fatty alcohols for use in the base and active agent Calif.) and Inner Mongolia Tianrun Castor Development Co., containing compositions of the invention include Stearyl alco Ltd. (Inner Mongolia, China). hol, cetyl alcohol, cetyl stearyl alcohol and behenyl alcohol, The amount (combined) of one or more plant or plant seed with stearyl alcohol being the most preferred, and is prefer oils that is optionally present in the active agent-containing ably present therein (without other fatty alcohols). A wide compositions of the invention, such as Castor oil, is an variety of other fatty alcohols are known by those having amount that is effective to cause the compositions to have one 10 ordinary skill in the art and are described in sources that are or more of the beneficial characteristics that are described known by those having ordinary skill in the art, such as in herein, such as causing, or aiding in causing (possibly along Stephen Mudge, “Fatty Alcohols. Anthropogenic and Natural with one or more other ingredients). Such compositions to Occurrence in the Environment” (Royal Society of Chemis function as an emollient upon the skin (i.e., to render the skin try, 1st Edition, ISBN-10:08.54041524, 2008). more soft than it would have been prior to applying the 15 Stearyl alcohol (also known as octadecyl alcohol or 1-oc compositions thereto). tadecanol), which is the most preferred fatty alcohol for use in Original Active Agent-Containing Compositions the base compositions and active agent-containing composi When present in the original active agent-containing com tions of the invention, is a Substance prepared from Stearic positions, the amount (combined) of one or more plant or acid by the process of catalytic hydrogenation, and has the plant seed oils that is present therein preferably ranges from molecular formula CH-so. It is a fatty alcohol that generally about 0.1 to about 24 weight percent, and more preferably is in the form of white solid granules or flakes that are ranges from about 8 to about 17 weight percent, and still more insoluble in water, and has a melting point of 60° C. and a preferably ranges from about 10 to about 15 weight percent, boiling point of 210°C. (at 15 mmHg or 2.0 kPa). and even more preferably ranges from about 11 to about 12 weight percent. 25 Stearyl Alcohol Improved Active Agent-Containing Compositions When present in the improved active agent-containing compositions, the plant oil(s) and/or plant seed oil(s), such as castor oil, preferably is present in the compositions in an -h-" amount (combined) preferably ranging from about 0.1 to 30 about 37.50 (from about 0.1 to about 37.0 if one or more flavoring ingredients are present) weight percent, and more Stearyl alcohol, and other fatty alcohols, are commercially preferably ranging from about 12.50 to about 37.50 (from available from sources that are known by those having ordi about 12.0 to about 37.0 if one or more flavoring ingredients nary skill in the art, for example, from Rita Corporation are present) weight percent, and still more preferably ranging 35 (Woodstock, Ill.), Sciencelab.com, Inc. (Houston, Tex.) or from about 24.0 to about 26.0 (from about 23.50 to about Alpha Aesar (Ward Hill, Mass.). 25.50 if one or more flavoring ingredients are present), and is Examples of other fatty alcohols that may be employed in most preferably about 25.0 (about 24.5 if one or more flavor the base compositions and active agent-containing composi ing ingredients are present) weight percent. tions of the invention include, but are not limited, to Stear Additional information about plant and plant seed oils 40 amine Oxide, StearylAcetate, Stearyl Caprylate, Stearyl Cit generally, and about Caster Oil specifically, including extrac rate, Stearyldimethyl Amine, Stearyl Glycyrrhetinate, Stearyl tion and refining methods therefore, is present in, for Heptanoate, Steary1 Octanoate, Stearyl Stearate, Plant example, Carol Schiller et al., “The Aromatherapy Encyclo Sources, Vegetable Stearic Acid, Cetyl Alcohol, Arachidyl pedia: A Concise Guide to over 385 Plant Oils' (Basic Health Alcohol, Behenyl Alcohol, Capric Alcohol, Capryl Alcohol, Publications, 1st Edition, ISBN-10: 1591202280, 2008): Fre 45 Ceryl Alcohol, Cetearyl Alcohol, Cetyl Alcohol, Cluyty1 deric P. Miller, “Castor Oil (Alphascript Publishing, ISBN Alcohol, Elaidolinolenyl Alcohol, Elaidolinoleyl Alcohol, 10: 6130261918, 2009); D.S. Oqunniyi, “Castor Oil: A Vital Elaidyl Alcohol, Erucyl Alcohol, Geddyl Alcohol, Heneico Industrial Raw Material (Bioresource Technology) syl, Heptadecyl Alcohol, Isostearyl Alcohol, Lauryl Alcohol, (Elsevier, 2006); Johann Vollmann, “Oil Crops. Handbook of Lignoceryl Alcohol, Linolenyl Alcohol, Linoleyl Alcohol, Plant Breeding' (Springer, 1st Edition, ISBN-10: 50 Melissyl Alcohol, Montanyl Alcohol, Myricyl Alcohol, 0387775935, 2009); Hermann Janson, “Castor Oil Produc Myristyl Alcohol, Nonadecyl Alcohol, Oleyl Alcohol, Palmi tion and Processing” (United Nations, ASIN: B0006DZ23G, toleyl Alcohol, Pelargonic Alcohol, Pentadecyl Alcohol, 1974); and/or Ernest Guenther, “The Essential Oils, Indi Ricinoleyl Alcohol, Tridecyl Alcohol, Undecyl Alcohol and vidual Essential Oils of the Plant Families” (Krieger Pub Co., Isostearyl Alcohol. ISBN-10; 0894647733, 1992). 55 The amount (combined) of one or more fatty alcohols that is optionally present in the active agent-containing composi Fatty Alcohols tions of the invention is an amount that is effective to cause the compositions to have one or more of the beneficial character One or a plurality offatty alcohols, such as Stearyl alcohol, istics that are described herein, Such as causing, or aiding in is optionally, but preferably, employed as a base ingredient in 60 causing (generally in combination with one or more other the compositions of the invention, and in the topical active ingredients). Such compositions to properly form, or be agent-containing compositions of the invention, and func present in a form of a solid or semi-solid structure, for tions primarily to cause, or aid in causing (generally in com example, in the shape of a stick or any another shape desired bination with one or more other ingredients). Such composi or required, or present in a pot or jar. tions to properly form, or be present in a form of a solid or 65 Original Active Agent-Containing Compositions semi-solid structure (preferably a Solid stick), but may also When present in the original active agent-containing com function as an emollient (skin Softener), thickener and/or positions, the amount (combined) of one or more fatty alco US 8,685,381 B2 69 70 hols that is present in these compositions, such as Stearyl about 17, 23, 26 and 35-37°C., respectively, with the B crystal alcohol, preferably ranges from about 0.1 to about 22 weight form being the most stable form. percent, and more preferably ranges from about 10 to about Cocoa butter, and other fats, are commercially available 22 weight percent, and still more preferably ranges from from sources that are known by those having ordinary skill in about 18 to about 22 weight percent. the art, for example, from Rita Corporation (Crystal Lake, Improved Active Agent-Containing Compositions Ill.) and Bulkoil.com (Greenbrae, Calif.). When present in the improved active agent-containing The amount (combined) of one or fats that is optionally compositions, the fatty alcohol(s). Such as Stearyl alcohol, present in the active agent-containing compositions of the preferably is present in the compositions in an amount (com invention, such as cocoa butter, is an amount that is effective bined) preferably ranging from about 0.1 to about 25 weight 10 percent, and more preferably ranging from about 15 to about to cause the compositions to have one or more of the benefi 25 weight percent, and still more preferably ranging from cial characteristics that are described herein, such as causing, about 19 to about 21 weight percent, and is most preferably or aiding in causing (generally in combination with one or about 20 weight percent (whether or not any favoring ingre more other ingredients). Such compositions to properly form, dients are present in the compositions). 15 or be present in a form of a solid or semi-solid structure, for Additional information about fatty alcohols is present, for example, in the shape of a stick or any another shape desired example, in Sylvia S. Talmage, “Environmental and Human or required, or present in a pot or jar. Safety of Major Surfactants. Alcohol Ethoxylates and Alky Original Active Agent-Containing Compositions phenol Ethoxylates' (CRC Press, 1st Edition, ISBN-10: When present in the original active agent-containing com 1566700175, 1994); and Egon Matijevic, “Surface and Col positions, the amount (combined) of the one or more fats that loid Science, Vol. 16' (Springer, 1st Edition, ISBN-10: is present therein preferably ranges from about 0.1 to about 9 030646456X, 2001). weight percent, and more preferably ranges from about 5 to about 9 weight percent, and still more preferably ranges from Fats about 6 to about 8 weight percent. 25 Improved Active Agent-Containing Compositions One or a plurality of fats, preferably having a melting point When present in the improved active agent-containing of at least about 85° F (29.444°C.), such as from about 34° C. compositions, the fat(s), such as cocoa butter, preferably is to about 38°C. (from about 93°F. to about 100°F), and which present in the compositions in an amount (combined) prefer more preferably have a melting point of at least about 90°F. ably ranging from about 0.1 to about 12 weight percent, and (32.222 C.) or higher, such as cocoa butter (also called 30 more preferably ranging from about 2 to about 12 weight theobroma oil or theobroma cacao), is optionally, but prefer percent, and still more preferably ranging from about 6 to ably, employed as a base ingredient in the compositions of the about 8 weight percent, and is most preferably about 7 weight invention, and in the topical active agent-containing compo percent (whether or not any favoring ingredients are present sitions of the invention. Such fat(s) function primarily to in the base compositions). cause, or aid in causing (generally in combination with one or 35 Additional information about fats is present, for example, more other ingredients). Such compositions to properly form, in Robin Dand, “The International Cocoa Trade” (CRC or be present in a form of, a solid structure (preferably a solid Press, 2nd edition, ISBN-10: 0849322669, 1999); and Stick), but may also function as an emollient (skin Softener), a Emmanuel Ohene Afoakwa, “Chocolate Science and Tech moisturizer and/or a binding agent therein. nology” (Wiley-Blackwell, ISBN-10: 1405199067, 2010). Examples of fats (and possibly oils in some cases) that may 40 be employed in base and other compositions of the invention Flavorings include, but are not limited, to Cocoa Butter, Shea Butter, Shea Nut Butter, Mango Butter, Costus Root, Calamas Root, One or more flavorings are, optionally, but preferably, Canola, Crisco, Cubeb, Ethyl Ricinoleate, Kokum Butter, employed as a base ingredient in the compositions of the Lanolin, Lard, Mowrah Butter and Tallow (Beef). A wide 45 invention, and in the topical active agent-containing compo variety of fats are known by those having ordinary skill in the sitions of the invention, and function to: (i) provide Such art and are described in Sources that are known by those compositions with a desirable and/or distinct aroma, fra having ordinary skill in the art, such as in Richard D. Obrien, grance and/or taste (i.e., they make the compositions Smell “Fats and Oils. Formulating and Processing for Applica and/or taste good and/or otherwise desirable to consumers tions” (CRC Press, 3rd Edition, ISBN-10: 142006 1666, 50 thereof, who may apply them to their lips); and/or (ii) effec 2008), Glen D. Lawrence, “The Fats of Life: Essential Fatty tively reduce, mask or eliminate one or more bitter and/or Acids in Health and Disease' (Rutgers University Press, other undesirable tastes and/or odors that are caused by, or ISBN-10:081354677X, 2010), and Icon Group International, otherwise result from, an inclusion of a different ingredient in “The 2009 Report on Confectionery and Ice Cream Coatings these compositions, such as hydrocortisone, which has a very made from Cacao Bean Cocoa and Fats other than Cocoa 55 bitter taste and odor, and generally causes compositions Butter. World Market Segmentation by City” (ICON Group including hydrocortisone to have a very undesirable bitter International, Inc., ASIN: B002AJG6AC, 2009). taste and odor. Preferred fats for use in the base compositions and active The flavorings that may be employed in the active agent agent-containing compositions of the invention include containing compositions of the invention may vary widely cocoa butter, shea butter and mango butter, with cocoa butter 60 and include, but are not limited to, Vanilla, chocolate, citrus being the most preferred, and preferably present therein alone flavors (lemon, orange, grapefruit and/or the like), fruit fla (i.e. without other fats). Vors (strawberry, cherry, kiwi, pineapple, blueberry, apple, Typically, cocoa butter is solid at room temperature, but grape, pear, cantaloupe and/or the like), cinnamon, mint readily melts at body temperature. It generally has a melting (spearmint, peppermint, wintergreen and/or the like), pina point of from about 34° C. to about 38°C. (from about 93° F. 65 colada, honey, molasses, caramel, butterscotch, butter pecan, to about 100°F). Cocoa butter displays polymorphism, gen ginger, Sassafras, hot pepper, Soda (cola, root beer, sprite, erally having C. Y. B' and B crystals, with melting points of ginger ale, cream Soda, Dr. Pepper and/or the like) and/or the US 8,685,381 B2 71 72 like. Virtually any type of a desired flavor or flavoring, or a oxidants, anti-inflammatory agents, antibiotic agents, anti combination thereof, may be employed. bacterial agents, antiviral agents, whitening agents, dispers The flavorings that may be employed in the base compo ing agents, thickening agents (Xanthan gum, guar gum, gum sitions and active agent-containing compositions of the arabic, methylcellulose, sodium carboxymethyl cellulose, invention may be natural flavorings, for example, a vanilla 5 carrageenan, starch and the like), anti-itch agents, polymers, flavoring procured from Vanilla beans, peppermint flavoring pigments, cell activating agents, Sunscreen agents, preserva procured from a peppermint plant, spearmint flavoring pro tives, colorants, collagen, glycerin, lecithin, talc, aloe Vera, cured from a spearmint plant, wintergreen flavoring procured lanolin or other agents, for example, vitamin E (a -toco from a creeping wintergreen or teaberry plant, lemon flavor pherol, B-tocopherol, Y-tocopherol, 8-tocopherol and the ing procured from a lemon or lemon peel, ginger flavoring 10 like). However, the compositions need not include any ingre procured from a ginger plant or root, Sassafras flavoring pro dients other than those that are described herein. cured from the dried root bark of a Sassafrastree, or synthetic Various optional ingredients that may possibly be or artificial flavorings, or extracts, such as an almond extract. All of the foregoing types of flavorings may be obtained by employed in the base compositions and active agent-contain methods that are known by those having ordinary skill in the 15 ing compositions of the invention may be described in, for art or are commercially available from sources that are known example, “Cosmetic Additives—An Industrial Guide” (Will by those having ordinary skill in the art, for example, from iam Andrew Publishing, 1991), “Cosmetic and Toiletry For Bell Flavors & Fragrances Inc. (Northbrook, Ill.). Interna mulations” (Volume 3, 2" Edition, William Andrew Publish tional Flavors and Fragrances (New York, N.Y.) and the Spice ing, 1995), “Handbook of Cosmetics and Personal Care” Barn (Lewis Center, Ohio). 2O (Gower Publishing Unlimited, ISBN 0566074702, 1994), The amount (combined) of one or more flavorings that is “Cosmetic Ingredients” (Three Rivers Press, ISBN optionally present in the active agent-containing composi 0609803670, 1999) and “Cosmetics Unmasked (Thorsons, tions of the invention is an amount that is effective to cause Harper Collins, ISBN 0-00-710568-1, 2001), and/or may be these compositions to: (i) have a pleasant or desirable, or a commercially available from Base Formula, Ltd. (Melton specific, taste and/or odor, such as a good and/or desirable 25 Mowbray, England), Well Naturally Products, Ltd. (Blaine, Vanilla taste and odor; (ii) have no, a reduced, or a minimal, Wash.), Essential Wholesale (Clackamas, OR), Urist Cos unpleasant taste and/or odor (in comparison with how the metics, Inc. (Richmond, Calif.) and/or Sciencelab.com, Inc. taste and/or odor would have been if no flavoring(s) had been (Houston, Tex.). Those having ordinary skill in the art may included in the compositions). Such as a reduction of a bitter determine the weight percents of one or more optional ingre taste and/or odor that would otherwise have been present as a 30 dients that may be employed in the base compositions and result of an inclusion of hydrocortisone in the compositions; active agent-containing compositions of the invention, and or (iii) have no taste and/or no odor. how to vary the other ingredients present therein accordingly. Original Active Agent-Containing Compositions Optional ingredients that may possibly be included in the When present in the original active agent-containing com base compositions and active agent-containing compositions positions, the amount (combined) of one or more flavorings 35 of the present invention include, but are not limited to, the that is present therein preferably ranges from about 0.1 to ingredients that are identified below, and Suitable amounts about 3.5 weight percent, and more preferably ranges from thereof, which may readily be determined by those having about 0.2 to about 3 weight percent, and even more preferably ordinary skill in the art. ranges from about 0.3 to about 2 weight percent, and still more preferably ranges from about 0.4 to about 1 weight 40 percent. Improved Active Agent-Containing Compositions Glycols Glycerin When present in the improved active agent-containing Propylene Glycol compositions, the flavoring(s). Such as Vanilla flavorings, Butylene Glycol preferably is present therein in an amount (combined) pref 45 Hexylene Glycol erably ranging from about 0.1 to about 3.5 weight percent, 2-Methyl Propane Diol and more preferably ranging from about 0.1 to about 2.5 Other Alcohols weight percent, and still more preferably ranging from about Ethanol 0.3 to about 1.5 weight percent, and is most preferably about sopropanol 0.5 weight percent. 50 n-propanol auryl alcohol Additional information about flavorings is present, for oleyl alcohol example, in Virginia Lanzotti et al., “Flavour and Fragrance Esters Chemistry (Proceedings of the Photochemical Society of Europea) (Springer, 1st edition, ISBN-10: 079236211X, sopropyl Myristate sopropyl Palmitate 2000); Carol Schiller et al., “The Aromatherapy Encyclope- 55 ojoba Oil dia: A Concise Guide to over 385 Plant Oils' (Basic Health Glyceryl tri caprate caprylate Publications, 1st Edition, ISBN-10: 1591202280, 2008); and Butyl Acetate Orlindo Secondini, “Handbook of Perfumes and Flavors” Propylene Glycol di Caprate/Caprylate Sorbitan Esters (Chemical Publishing Company, ISBN-10: 0820603341, Diesters of Diacids 1990). 60 Ethyl Acetate Ethoxylated Materials Other Optional Ingredients Ethoxylated Fatty Alcohols Ethoxylated Fatty Acids The base compositions and active agent-containing com Ethoxylated Sorbitan Esters positions of the invention may, in some cases, optionally, 65 Ethoxylated Glycerides contain one or more other (additional or Substitute) active or Ethoxydiglycol inactive ingredients, such as various vitamins, minerals, anti US 8,685,381 B2 73 74 -continued the second formulation does not include any flavoring (and the weight percent of the Castor Oil is increased by the same Ketones weight percent that is missing with respect to the missing Acetone flavoring to compensate for the absent flavoring, which may Methyl Ethyl Ketone also be done with other absent formulation ingredients). This Other Waxes. Bases is the same case with the two improved formulations. These Lubragels compositions have all been determined via topical skin appli Zigels cation testing on human beings, as is discussed in the Jojoba Glaze “Examples' section, and as is illustrated in FIGS. 2-17, to be Absorption Bases 10 extremely efficacious for deeply penetrating, conditioning Aliphatic Compounds and healing, various layers of, and tissues present in, the skin n-alkanes of human beings, including the dermis and epidermis, in branched alkanes connection with various skin disorders, diseases and condi Permethyls tions of human beings, as are described herein, and for main Propoxylated Materials Propoxylated Fatty Alcohols 15 taining their forms, shapes and consistencies under adverse Propoxylated Fatty Acids environmental conditions. Esters of Propoxylated Fatty Alcohols Ethoxylated Propoxylates Aerosol Propellant Gases Original Active Agent-Containing Formulations Anhydrous Ionic Surfactants Phosphate Esters Sulfates Carboxylates Fatty Amine Salts Ingredient Weight Percent Quaternary Nitrogen Salts Hydrocortisone 1.O Other Fats, Oils and Waxes 25 FANCOLVEB 11.0 Natunola Castor 1023 18.0 Derived from Animals, Minerals, Marine Finsolv TN 11.0 or Other Sources BeeSWax 2O.O Silicones Castor Oil 11.5 Stearyl Alcohol 2O.O Dimethicone 30 Cocoa Butter 7.0 Simethicone Cyclomethicone Flavoring (Vanilla) O.S Dimethicone Ethoxylates and Propoxylates TOTAL 100 Fluorocarbons and Derivatives Zonyls 35 Fluorocarbon Alcohols Amides Ingredient Weight Percent Fatty Acid Diethanolamides Fatty Acid Monoethanolamides Hydrocortisone 1.O Fatty Acid Dimethylaminopropyl 40 FANCOLVEB 11.0 Amides Natunola Castor 1023 18.0 Finsolv TN 11.0 BeeSWax 2O.O Polyalkenes Castor Oil 12.0 Polyoxyethylenes Stearyl Alcohol 2O.O Polyoxypropylenes 45 Cocoa Butter 7.0 Polyamides Flavoring (Vanilla) O.O Polyesters Polyurethanes TOTAL 100 Cellulostics and Derivatives Copolymers 50 Improved Active Agent-Containing Formulations Most Preferred Active Agent-Containing Compositions 55 Two of the most preferred original active agent-containing Ingredient Weight Percent compositions of the present invention, and two of the most Hydrocortisone 1.O preferred improved active agent-containing compositions of FANCOLVEB 11.00 the present invention, contain the ingredients that are set forth Natunola Castor 1023 10.00 FINSOLVTN 1S.OO below, and the weight percents thereof (of the 100% total 60 BeeSWax 11.00 weight of the composition), and preferably do not include any Castor Oil 24.50 different or additional ingredients, and are produced in the Stearyl Alcohol 2O.OO form of a solid cylinder (stick), Such as a traditional Chap Cocoa Butter 7.00 Stick(R) form, but in various sizes, for example, in the two Flavoring (Vanilla) O.SO different sizes that are illustrated in FIG. 1, and in a form that 65 TOTAL 1OO is contained in a pot, jar or can. The first original formulation includes a flavoring, and is the more preferred of the two, and US 8,685,381 B2 75 76 size of the batch of the composition being produced, which may be determined by those having ordinary skill in the art Ingredient Weight Percent and, as one example may be about 11.0 g, is then added to the Hydrocortisone 1.O plant oil(s) and/or plant seed oil(s) in the drum (if present), FANCOLVEB 11.00 and mixed with therewith until it is preferably completely Natunola Castor 1023 1O.OO dissolved therein, which generally takes from about 30 to FINSOLVTN 1S.OO BeeSWax 11.00 about 45 minutes, while maintaining a temperature that is Castor Oil 2S.OO effective for preferably evenly heating the mixture and com Stearyl Alcohol 2O.OO pletely dissolving the FANCOLVB in the oil(s), which gen Cocoa Butter 7.00 10 erally ranges from about 75° C. to about 85°C. If no plant Flavoring (Vanilla) O.O oil(s) or plant seed oil(s) are employed in the first step, the TOTAL 1OO FANCOLVB is added to the steel drum and heated using a conventional hot plate to the foregoing temperature, which is effective for evenly heating the FANCOLVB in the drum Preparation of Compositions 15 An amount of Natunola Castor 1023 that is sufficient for The base compositions and active-agent containing com producing an effective composition of the invention in a form positions of the invention (whether or not including one or that may be properly filled into a suitable container or pack more active agents) are preferably prepared in the manner that aging, and topically applied to the skin of a mammal, with the is described below, or elsewhere herein, preferably employ amount of Natunola Castor 1023 possibly varying widely ing the specified order of steps and process conditions iden depending upon the size of the batch of the composition being tified therein (amounts, times, temperatures, mixing and the produced, which may be determined by those having ordinary like), but may be prepared using other methods that produce skill in the art and, as one example may be about 18.0g, is then compositions having the features and/or characteristics that added to the above product, such as a mixture of plant oil(s) are described herein, using customary equipment that is and/or plant seed oil(s) and FANCOLVB, in the drum while known by those having skill in the art for preparing topical 25 a temperature that is effective for preferably evenly heating skin products or other equipment. the mixture and dissolving the Natunola Castor 1023 therein Although the methods that are described below (and else is maintained, which generally ranges from about 75° C. to where herein) refer to the active agent hydrocortisone, other about 85°C. Mixing is then preferably continued for a period active agents can be used in these methods in addition to, or of time that is sufficient to completely dissolve the Natunola alternatively to, hydrocortisone (in the same or similar man 30 Castor 1023 therein, which typically ranges from about 30 to ner described). The hydrocortisone (and/or other active about 60 minutes. agent(s)) may be physically combined with the base compo An amount of bees wax that is sufficient for producing an sition that is described herein to achieve the concentrations effective composition of the invention in a form that may be that are described herein by stirring together, or otherwise properly filled into a suitable container or packaging, and mixing or combining, the individual components in the man 35 topically applied to the skin of a mammal, with the amount of ner that is described herein (preferably with continuous mix beeswax possibly varying widely depending upon the size of ing). Preferably, sufficient agitation to achieve relative homo the batch of the composition being produced, which may be geneity of the various ingredients in the compositions is determined by those having ordinary skill in the art and, as employed. Agitation may be achieved, for example, using a one example may be about 20.0 g, is added to the above standard (or other) mixer, at a slow, moderate or even vigor 40 mixture in the drum while a temperature that is effective for ous speed. Using the information that is provided herein, preferably evenly heating the mixture and dissolving the bees those having ordinary skill in the art will be able to vary these wax therein is maintained, that temperature generally ranging methods and compositions in a manner desired or required from about 75° C. to about 85° C. Mixing is preferably under a particular set of circumstances or to produce a par continued for a period of time that is sufficient to completely ticular base composition or active agent-containing compo 45 dissolve the bees wax therein, which typically ranges from sition of the invention. about 30 to about 45 minutes. To prepare the original base and active-agent formulations An amount (combined) of one or more fatty alcohols, such of the invention, an amount (combined) of one or more plant as Stearyl alcohol, that is sufficient for producing an effective oils or plant seed oils, such as castor oil, that is Sufficient for composition of the invention in a form that may be properly producing an effective base or active agent-containing com 50 filled into a Suitable container or packaging, and topically position of the invention in a form that may properly be filled applied to the skin of a mammal, with the amount of the fatty into a Suitable container or packaging, and topically applied alcohol(s) possibly varying widely depending upon the size to the skin of a mammal, with the amount thereof possibly of the batch of the composition being produced, which may varying widely depending upon the size of the batch of the be determined by those having ordinary skill in the art and, as composition being produced, which may be determined by 55 one example may be about 20.0g, is then optionally added to those having ordinary skill in the art and, as one example may the above mixture in the drum while a temperature that is be about 11.5 g, is optionally added to a standard stainless effective for preferably evenly heating the mixture and dis steel drum including a mixer and heated using a conventional Solving the fatty alcohol(s) therein is maintained, that tem hot plate to a temperature that is effective for evenly heating perature generally ranging from about 75°C. to about 85°C. the plant oil(s) and/or plant seed oil(s) in the drum, which 60 If fatty alcohol(s) are added, mixing is preferably continued generally ranges from about 75° C. to about 85°C., while for a period of time that is sufficient to completely dissolve the stifling it continuously using the mixer. fatty alcohol(s) therein, which typically ranges from about 30 An amount of FANCOLVB that is sufficient for producing to about 45 minutes. an effective composition of the invention in a form that may An amount (combined) of one or more fats, such as cocoa be properly filled into a suitable container or packaging, and 65 butter, that is Sufficient for producing an effective composi topically applied to the skin of a mammal, with the amount of tion of the invention in a form that may be properly filled into FANCOL VB possibly varying widely depending upon the a suitable container or packaging, and topically applied to the US 8,685,381 B2 77 78 skin of a mammal, with the amount of the fat(s) possibly flavorful or less aromatic, than it was originally (i.e., prior to varying widely depending upon the size of the batch of the incorporating it therein), which generally ranges from about composition being produced, which may be determined by 50° C. to about 55°C., and then the flavoring(s) is added to the those having ordinary skill in the art and, as one example may mixture. The flavoring(s), if added, is preferably mixed with be about 7.0g, is optionally added to the above mixture in the the mixture for a period of time that is sufficient to incorporate drum while a temperature that is effective for preferably it evenly throughout the mixture, which generally ranges evenly heating the mixture and dissolving the fat(s) therein is from about 15 to about 20 minutes, while preferably main maintained, that temperature generally ranging from about taining a temperature that is effective for permitting Such even 75°C. to about 85°C. If fat(s) are added, mixing is preferably distribution of the flavoring in the mixture, that temperature continued for a period of time that is sufficient to completely 10 generally ranging from about 50° C. to about 55° C. dissolve the fat(s) therein, which typically ranges from about At this point in the above process, the resulting mixture will 30 to about 45 minutes. preferably be liquid in nature, and may have a light yellow An amount of Finsolv TN that is sufficient for producing an color and a general appearance of a thin, milky liquid. For effective composition of the invention in a form that may be active agent-containing compositions, a sample of the result properly filled into a suitable container or packaging, and 15 ing mixture is then preferably analyzed using standard tech topically applied to the skin of a mammal, with the amount of niques known by those having ordinary skill in the art, such as Finsolv TN possibly varying widely depending upon the size High Performance Liquid Chromatography (HPLC) or Gas of the batch of the composition being produced, which may Chromatography (GS), to determine the concentration of the be determined by those having ordinary skill in the art and, as active agent(s) that is present in the mixture, as one example, one example may be about 11.0 g, is added to the above 1 weight percent of hydrocortisone. mixture in the drum while a temperature that is effective for For the active agent-containing compositions, once the preferably evenly heating the mixture and dissolving the Fin sample is found to be acceptable (i.e., to possess the above solv TN therein is maintained, that temperature generally characteristics and the desired concentration of the active ranging from about 75° C. to about 85°C. Mixing is prefer agent(s) therein), the entire batch of the composition is pref ably continued for a period of time that is sufficient to com 25 erably transferred to a filler assembly line, where it is poured pletely dissolve the Finsolv TN therein, which typically or otherwise transferred (manually, robotically or otherwise) ranges from about 30 to about 45 minutes. into individual (or other) containers or molds of any desired The above mixture is preferably mixed for an additional size, shape and/or other characteristics, to preferably form a period of time that is Sufficient to have any remaining par Solid, preferably in a cylindrical shape. Such as those that are ticles present therein preferably be completely dissolved in 30 illustrated in FIG. 1, or a traditional ChapStickR) type (or the mixture, which generally ranges from about 30 to about other) stick. Standard filling equipment that is known by 60 minutes, while a temperature that is sufficient to dissolve those having ordinary skill in the art may be used for this step. Such particles in the mixture is preferably maintained, which A wide variety of plastic, glass, metal and other types and generally ranges from about 75° C. to about 85°C. materials of containers, cases, pouches, bottles, jars, Squeez If the composition being produced is an active-agent con 35 able (or other) tubes (lip balm, roll-on, roll-up and/or the taining composition, the resulting mixture is then preferably like), vials, boxes, bags, pots, tins, cans, lids, other closures, permitted to cool (naturally or using conventional cooling and/or the like, having a wide variety of different sizes, equipment, such as a refrigerator) to a temperature that is shapes, colors and/or other physical attributes, and made from effective for mixing hydrocortisone (and/or other active a wide variety of different materials, or combinations thereof, ingredient(s)) therewith in a manner that does not render the 40 which may be used to removably or irremovably contain or hydrocortisone (and/or other active ingredient(s)) ineffective house the compositions are available from sources that are or significantly less effective than it was in its original form known by those having ordinary skill in the art, Such as from (i.e., prior to adding it to the above mixture), which typically SKS Bottle and Packaging, Inc. (Watervliet, N.Y.). For ranges from about 55° C. to about 60° C. example, the compositions may be present in individual con An amount of hydrocortisone (and/or other active ingredi 45 tainers that form around, house or contain a Solid in a shape of ent(s)) that is sufficient for producing an effective active a stick, as is shown in FIG. 1, which may be partially or fully agent-containing composition of the invention in a form that removed from the container for use by a user by exerting a may be properly filled into a suitable container or packaging, twisting or turning action of the end of the container that does and topically applied to the skin of a mammal, with the not include the closure (lid, cap or the like). Alternatively, combined amount of the hydrocortisone and/or other active 50 they may be present in lip gloss sized and types of pots orjars, ingredient(s) possibly varying widely depending upon the and do not become removed from the containers by a user size of the batch of the composition being produced, which when being used, and/or the like. may be determined by those having ordinary skill in the art After the compositions settle, and possibly harden into and may be, as one example about 1.0 g, is then added to the Solid forms, in the containers, which generally takes a period above mixture and mixed therewith preferably until it is dis 55 of time ranging from about 60 to about 120 minutes, a con Solved while maintaining the temperature of the mixture at tainer cap is preferably applied to the open end of each con the above temperature (i.e., preferably ranging from about tainer, preferably along with a label including identifying 55° C. to about 60° C.), which typically takes from about 30 and/or other information, Such as a lot code. to about 45 minutes. The resulting product is then preferably individually pack The resulting mixture (not including any active ingred 60 aged using conventional packaging equipment known by ient(s) for a base composition or including one or more active those having ordinary skill in the art, or otherwise, into ingredient(s) for an active agent-containing composition) is required or desired packaging of any type, which may or may then permitted to cool (naturally or using conventional cool not be tamper-evident and/or childproof. Such as a paper or ing equipment, Such as a refrigerator) to a temperature that is cardboard box, an aluminum or plastic pouch or sheath, and/ effective for optionally incorporating one or more flavorings 65 or the like. Alternatively, or in addition, tamper-evident and/ therein in a manner that preferably does not render the fla or childproof plastic and/or other material may be placed, Voring less flavorful or less aromatic, or Substantially less formed, wrapped and/or sealed around the cap (or other) US 8,685,381 B2 79 80 area(s) of the container in a manner that indicates (to a con skin of a mammal directly or indirectly in any convenient or Sumer) tampering of the container when torn, perforated or desired manner, such as by rolling it directly upon the skin otherwise damaged or disrupted. using a plastic or metal (or other) roll-up applicator, as is The improved base and active-agent formulations of the shown in FIG.1, or roll-on applicator, like those used to apply invention may be prepared in a similar manner using the same 5 deodorant to the skin, indirectly by using one or more fingers or similar steps and conditions. However, it is preferred that to brush or Sweep across the Surface of the compositions, such Such formulations be prepared by adding the various ingre as when they are present in a roll-up applicator, a roll-on dients in the following order, rather than in the order applicator, a lip gloss type of apotorjar, a spray, foam or other described above, with mixing until the various ingredients are can, or the like, and then using the fingers to apply the com fully dissolved within the prior-listed ingredients: 10 positions to the skin using rubbing, Sweeping, patting or other (1) Castor Oil (Plant Oil); (2) FANCOLVB; actions. These compositions may be applied to any sized area (3) Bees wax: of the skin including, but not limited to, an area the size of a (4) Stearyl Alcohol (Fatty Alcohol); pinpoint (or Smaller) to an area that spans one or a plurality of (5) Cocoa Butter (Fat); 15 square centimeters, inches or even feet (or larger). As a gen (6) Finsolv TN; eral rule, the larger the area to be treated, the larger a roll-up (7) Natunola 1023; or roll-on or other applicator should be (for ease and speed of (8) Hydrocortisone (Active Ingredient); and application). (9) Flavor Ingredient(s). The active agent-containing compositions may be distrib Application and Application Rates 2O uted to, or otherwise applied to, the skin, using a variety of The base compositions and active-agent containing com different types of applicators and may, optionally, be exter positions of the invention, such as those including hydrocor nally or internally heated by a heating device. Such as an tisone and/or other active ingredients, and the related meth electrical current from a battery or similar device, to elevate ods, can be employed by physicians, such as dermatologists, the temperature of the compositions prior to an application to nurse practitioners, nurses, other skin care professionals, vet- 25 the skin, for example, from ambient temperature to a tem erinarians, and/or the like, as well as by lay (or other) indi perature ranging from about 5°C. (9°F) to about 10°C. (18° viduals, to repair, improve, partially heal (i.e., having a heal F.) above ambient temperature (or higher) upon application or ing of the skin that is greater than about 0% but less than about desire to apply. If the temperature of the composition is 100% in comparison with the condition of the skin just prior elevated to one that is at, or greater than, the melting point of to a first application of a composition of the invention to the 30 the composition, a portion or all of the composition may skin) or fully heal (i.e., having a healing of about 100%) a wide variety of different skin disorders, diseases and adverse become transformed by melting from a "solid’ form to a conditions, as are described herein (or otherwise), of the skin “semi-solid form or “liquid.” Such an elevated temperature of a mammal and/or to produce or increase some other benefit may cause a "solid composition to partially or fully melt and to the skin. 35 become transformed into a “semi-solid' or even a liquid, and An improvement in (greater than 0%, but less than 100%, applied to the skin of a mammal in Such transformed form. An repair or healing), or a full (100%) healing of the skin of a elevated temperature that is below the melting point of the mammal that has been treated with a composition of the composition may cause the composition to become softened invention may be detected in a variety of different manners, or more pliable. A separated chamber of a container housing such as by a visually observable or otherwise detectable (by 40 the composition may or may not contain the composition to palpitation, touch, feel, Smell and/or the like) improvement in be softened or melted prior to application to the body and/or the morphology, tone, texture and/or appearance of the skin of lips. The ability to push the composition to this potential the mammal, including, but not limited to, a reduction or separate chamber may be controlled, for example, by a small elimination in the quantity and/or severity of pain, discom aperture in the composition which could be Small enough to fort, Soreness, burning, itching, inflammation, redness (or 45 push composition through upon revolution of the composi other discoloration), bruising, bumps, blisters, cracking, cuts, tion chamber below and pressure upward. This chamber perforations, punctures, other wounds, dryness or other could then be heated selectively, allowing the composition defects, deformations and/or conditions, and/or the like. In below it to remain in its non-melted form. The ability to heat addition, or alternatively, to being detected visually or manu it would be controllable by, for example, a button-device on ally, such an improvement may also be detected by question- 50 the side of the chamber. It is also possible to alter the amounts ing a patient for, example, to determine whether or not less of the compositions that are delivered to the skin at one time pain and/or discomfort is present or experienced by the by sealing off a device delivery system from the actual com patent, or by using a wide variety of different dermatologic position below, thereby reducing the potential contamination and/or other medical devices, tests and/or equipment, which of the product below the area touching the skin or lips. are known by those having ordinary skill in the art, Such as 55 The compositions of the invention that include hydrocor photographic analysis, grading scales related to psoriatic and tisone and/or one or a plurality of other active agents are eczematous disease such as, but not limited to, the PASI preferably applied directly or indirectly to the skin of a mam (Psoriasis Area and Severity Index) and EASI (Eczema mal in an amount, and for a number of applications, that are Severity and Severity Index) scores, and visual observation. effective for causing or providing: (i) a repair of, or an As is illustrated in the accompanying drawings, photo- 60 improvement in, the mammal’s skin in Some manner and/or graphic, visual observation or other comparisons may readily partially or fully healing one or more disorders, diseases, be made between a mammal’s skin, as it existed prior to adverse (or other) conditions, maladies and/or the like of the initiating a first treatment thereof with a composition of the mammal’s skin, for example, a decrease in inflammation, invention, and as it existed at the termination of Such treat Swelling, irritation, burning, itching, redness, pain, Soreness, ment, or at any point or time in between the two. 65 extreme (or other) dryness, bumps, blisters, itching, cracking, The compositions of the invention that include one or more acne excoriae, insect bite size, wound size and/or the like, as active components may be applied to different areas of the are described herein or otherwise; and/or (ii) a reduction in US 8,685,381 B2 81 82 pain, Soreness, discomfort, itchiness and/or the like, and/oran tion using the pot or jar. However, Such quantities to be increase in a soothing, softening, conditioning and/or the like, delivered per application can be decreased or increased, as is of the mammal’s skin. desired or required by a user, by rolling (or otherwise apply The total amount of the hydrocortisone (and/or other active ing) the Stick(s) (or other application device) over Smaller or agent) formulation of the invention that is effective for larger areas of the skin per application and/or by decreasing or improving the skin in Some manner and/or for partially or increasing the number of times that the Stick(s) (or other fully healing one or more skin conditions, disorders, diseases, application device) is rolled (or otherwise applied) over the maladies and/or the like, as are described herein (or other same or different areas of the skin per application. wise), may vary widely, depending upon a variety of factors, Thus, as only by way of Some examples, the following Such as the type, age, sex, genetic predisposition and general 10 quantities of compositions within the present invention, or health of the mammal being treated, whether the mammal is others, may be administered to a user per application (ing or a human or non-human mammal, the amount of the mam ml), as well as any quantities in between: mals exposure to adverse or harsh environmental conditions, 0.01. 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, Such as the Sun, wind, heat and/or cold, the particular active 0.3, 0.4,0.5,0.6,0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, agent, or combination of active agents employed, the particu 15 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, lar formulation employed, the particular condition(s), disor 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, der(s), disease(s), malady(s) and/or the like being treated, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, and/or the like, and may readily be determined by those 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4., 6.5, 6.6, 6.7, having ordinary skill in the art using the information that is 6.8, 6.9. 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0. provided herein. 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0.9.19.2, 9.3, The amount of an active agent-containing composition of 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, the invention that will generally be effective for achieving or 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, obtaining one or more of the goals that are described herein 11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, may readily be determined by those having ordinary skill in 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, the art. The quantity of such a composition to be administered 25 13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4, to a mammal for each application, and the number of appli 14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.1, 15.2, 15.3, 15.4, cations to be applied, depend upon the nature of the compo 15.5, 15.6, 15.7, 15.8, 15.9, 16.0, 16.1, 16.2, 16.3, 16.4, sition, the condition(s) being treated and the area(s) of the 16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, 17.2, 17.3, 17.4, body involved, and may be determined by those having ordi 17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1, 18.2, 18.3, 18.3, nary skill in the art using the information contained herein. 30 18.4, 18.5, 18.6, 18.7, 18.8, 18.9, 19.0, 19.1, 19.2, 19.3, With that being said, the amount of a composition that is 19.4, 19.5, 19.6, 19.7, 19.8, 19.9, 20.0, 20.1, 20.2, 20.3, applied to the skin of a mammal per each application prefer 20.4, 20.5, 20.6, 20.7, 20.8, 20.9, 21, 22, 23, 24, 25, 26, ably ranges from about 1 to about 20 g or ml, and more 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 and preferably ranges from about 2 to about 12 g or ml, and still so forth. more preferably ranges from about 3 to about 8 g or ml, and 35 The number of applications of a composition to the skin of even still more preferably ranges from about 4 to about 6 g or a mammal that will generally be effective for producing one ml, with about 5g or ml being most preferred. For example, or more desired effects, as are described herein, and the about 5 g of the composition may be applied to the skin of a period of time during which Such applications are made, may mammal from a suitable container or applicator and spread vary widely, depending upon a variety of factors, such as the over, or rubbed into, the skin using the hands or fingers or a 40 concentration of the one or more active agents that are present Suitable application or other device. However, Such amounts in the composition, the amount of the composition that is can vary widely, with the lowest quantity generally being an applied to the mammal’s skin, the condition of the mammals amount that renders some improvement in the skin (either skin, the amount of the mammal’s Sun exposure and the type, alone or in a series of multiple applications), with there not age, sex, genetic predisposition and general health of the being an upper limit to the largest quantity (other than safety 45 mammal, and may readily be determined by those having concerns). Although there generally is no upper limit to the ordinary skill in the art using the information provided herein. quantity of composition that can be applied per application, While the skin of a mammal may exhibit some improvement above a certain quantity, no further improvement in the mam after only one application of a composition thereto, in order to mal's skin may be observed or otherwise detected. obtain a more pronounced or full effect or benefit, it is typi The following types and sizes of applicators for composi 50 cally beneficial to provide two or more applications to the tions within the invention were used in the experiments that mammal’s skin, and more typically beneficial to provide at are described in Examples 6-9 hereinbelow. least about three applications of the composition to the skin of (i) a 0.15 fluid ounce stick-shaped roll-up skin balm mea the mammal (three, four, five, six, seven, eight, nine, ten, Suring about 6.0 cm in length and about 1.5 cm in diam eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eter (a Suitable size for a lip and face balm—a small 55 eighteen, nineteen, twenty, twenty-one, twenty-two, twenty Stick); three, twenty-four, twenty-five, twenty-six, twenty-seven, (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm mea twenty-eight, twenty-nine, thirty and so forth applications) Suring about 7.6 cm in length and about 2.0 cm in diam continuously over a period of at least about one day or week, eter (a Suitable size for a body balm—a large Stick); and or a series of days or weeks (one, two, three, four, five, six, (iii) a 0.25 fluid ounce jar-shaped skin balm measuring 60 seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fif about 3.0 cm in length and about 3.3 cm in diameter (a teen, sixteen, seventeen, eighteen, nineteen, twenty, twenty Suitable size for a face balm—a pot orjar). one, twenty-two, twenty-three, twenty-four, twenty-five, In these or other experiments, about 0.1 g or ml of composi twenty-six, twenty-seven, twenty-eight, twenty-nine, thirty tion was delivered to a patient per application using the Small and so forth days or one, two, three, four, five, six, seven, stick, about 0.5g or ml of composition was delivered to a 65 eight, nine, ten, eleven, twelve, and so forth weeks). The patient per application using the large stick, and about 0.15g compositions may, for example, be applied as a solid Stick (or or ml of composition was delivered to a patient per applica other solid form), a cream, a gel, a lotion, an ointment or other US 8,685,381 B2 83 84 convenient form as frequently as once per 15 minutes (or per number of applications of the composition that can be applied fewer minutes, such as 1, 5 or 10 minutes) and as infrequently to the skin of a mammal, above a certain number of applica as once per day or so or on an “as needed basis (i.e., applied tions, no further improvement in the mammal’s skin may be as believed to be necessary or desirable, or required, typically observed or otherwise detected. It will typically not be rec depending upon the types and severity of symptoms). ommended to apply the compositions to the skin of a mammal Usually, the greater the number of applications of the com more than about 48 times within a one-day (24 hour) period. position to the skin of a mammal within a given period of The table below shows examples of some of the application time. Such as a period of one week, the greater an improve protocols that can be employed with the hydrocortisone and ment will be observed or otherwise detected in the mammals other active agent-containing compositions of the invention skin, and the less time will be required for achieving Such 10 at concentrations that are described herein. results. Although there generally is no upper limit to the Examples of Application Protocols

Number of Applications Number of Days 1 time each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 41, 42,43, 44, 45,46, 47,48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62,63, 64, 65, 66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98,99, 100, 101, 102, 103, 104, 105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135,136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 2 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 41, 42,43, 44, 45,46, 47,48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62,63, 64, 65, 66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98,99, 100, 101, 102, 103, 104, 105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135,136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 3 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 41, 42,43, 44, 45,46, 47,48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62,63, 64, 65, 66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98,99, 100, 101, 102, 103, 104, 105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135,136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 4 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 41, 42,43, 44, 45,46, 47,48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62,63, 64, 65, 66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98,99, 100, 101, 102, 103, 104, 105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135,136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 5 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 41, 42,43, 44, 45,46, 47,48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62,63, 64, 65, 66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98,99, 100, 101, 102, 103, 104, 105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135,136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, US 8,685,381 B2 85 86 -continued

Number of Applications Number of Days 78, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 93, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 6 times each day , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, O3, 104,105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 18, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 33, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 48, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 63, 164, 165, 166, 167, 168, 169, 170, 171, 172,173, 174, 175, 76, 177, 78, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 93, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 7 times each day , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 8 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 9 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 10 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 11 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, US 8,685,381 B2 87 88 -continued

Number of Applications Number of Days 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 12 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 13 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 14 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 15 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 16 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 17 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, US 8,685,381 B2 89 90 -continued

Number of Applications Number of Days 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 18 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 46, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 19 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 20 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 21 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 22 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 61, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 76, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 91, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 23 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 2 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 4 , 42, 43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 6 , 62, 63, 64, 65,66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 8 , 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, O1, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 16, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 31, 132, US 8,685,381 B2 91 92 -continued

Number of Applications Number of Days 33, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 48, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 63, 164, 165, 166, 167, 168, 169, 170, 171, 172,173, 174, 175, 176, 177, 78, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 93, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 24 times each day , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 41, 42,43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 61, 62,63, 64, 65, 66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, 101, 102, O3, 104,105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 18, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 33, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 48, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 63, 164, 165, 166, 167, 168, 169, 170, 171, 172,173, 174, 175, 176, 177, 78, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 93, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 25 times each day , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34,35, 36, 37,38, 39, 40, 41, 42,43, 44, 45,46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 61, 62,63, 64, 65, 66, 67,68, 69, 70, 71, 72, 73,74, 75, 76, 77,78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89,90,91, 92,93, 94, 95, 96, 97,98, 99, 100, 101, 102, 103,104,105,106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203,204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days)

It is preferable, but not necessary, that the various applica the condition of the skin of the mammal will often be tions of the composition of the invention that are applied each observed or otherwise detected after a period of from about day be equally spaced with a 24-hour period. For example, it 35 one to about four days. If the same composition is applied is preferable that two applications that are to be applied in one three times per day to the mammal’s skin, an improvement in day are applied approximately 12 hours apart. It is preferable the condition of the mammal’s skin will often be observed or that three applications that are to be applied in one day are otherwise detected after a period of from about one to about applied approximately 8 hours apart. It is preferable that four three days. If the same composition is applied four times per applications that are to be applied in one day are applied 40 day to the mammal’s skin, an improvement in the condition of approximately 6 hours apart. It is preferable that five appli the mammal’s skin will often be observed or otherwise cations that are to be applied in one day are applied approxi detected after a period of from about one to about two days. If mately 4.8 hours apart, and so forth. It is also preferable that the same composition is applied five times per day to the days not be missed when a series of applications are to be 45 mammal’s skin, an improvement in the condition of the mam made over a specified number of days. mal's skin will often be observed or otherwise detected after An improvement in an adverse (or other) skin condition, a period of from about one to about two days. More rapid disease, disorder and/or the like of a mammal, and/or an results may likely beachieved when compositions containing improvement in one or more characteristics of the mammals higher weight percents of the hydrocortisone (and/or other skin generally, will very often be observed or otherwise 50 active agent). Such as 2, 3, 4 or 5 weight percent of the detected (via touch, a test and/or the like) as soon as one day hydrocortisone (and/or other active agent), are applied to the after a first topical application of a composition of the inven skin of a mammal using the foregoing application rates. Typi tion thereto and no later than one week after such first appli cally, the higher the concentration of the hydrocortisone (or cation. However, such times may vary depending upon a other active agent) that is present in the compositions, the variety of factors, such as the type and severity of skin prob 55 more rapid the beneficial results thereof will be observed or lem being treated, the age, sex and general health of the otherwise detected. patient being treated, the amount of the active ingredient(s) Sources of Ingredients present therein, and like factors, which may be determined by All of the ingredients, materials and equipment employed those having ordinary skill in the art. in the methods of the invention are commercially available As an example, after a composition containing about 1 60 from Sources known by those having ordinary skill in the art, weight percent of hydrocortisone (and/or one or more other Such as those that are described hereinabove, and Botagenics, active agents) is applied one time per day to the skin of a Inc. (Northridge, Calif.), Base Formula, Ltd. (Melton Mow mammal that requires, or could benefit from, skin treatment, bray, England), Well Naturally Products, Ltd. (Blaine, an improvement in the condition of the skin will often be Wash.), Essential Wholesale (Clackamas, Oreg.), Urist Cos observed or otherwise detected after a period of from about 65 metics, Inc. (Richmond, Calif.), Sciencelab.com, Inc. (Hous one to about seven days. If the same composition is applied ton, Tex.), Fluka Chemical and Biochemical Co. two times per day to the mammal’s skin, an improvement in (Ronkonkoma, N.Y.), Sony North America (New York, N.Y.), US 8,685,381 B2 93 94 NOVA Technology Corporation (Portsmouth, N.H.). Ser 18.0 g of Natunola Castor 1023 was added to the mixture of voMed (Sweden), (Expo Engineered Inc., Cicero, Ill.) and castor oil and FANCOLVB in the drum while a temperature Lovely Skin (Omaha, Nebr.). ranging from about 75° C. to about 85°C. was maintained. The following examples describe and illustrate the base Mixing of the ingredients was then continued for about 60 compositions and active agent-containing compositions, and minutes. methods, of the present invention. These examples are 20.0 g of beeswax was then added to the above mixture in intended to be merely illustrative of the present invention, and the drum while a temperature ranging from about 75° C. to not limiting thereof in either scope or spirit. Those having about 85°C. was maintained. Mixing was continued for about ordinary skill in the art will readily understand that variations 30 minutes, which was sufficient to completely dissolve the of certain of the ingredients, amounts, conditions and/or steps 10 bees wax therein. employed in the procedures described in the examples can be 20.0 g of stearyl alcohol was then added to the above employed. mixture in the drum while a temperature ranging from about 75°C. to about 85°C. was maintained. Mixing was continued All of the experimental testing of compositions within the for a period of about 30 minutes, which was sufficient to present invention that is described in these examples was 15 completely dissolve the stearyl alcohol therein. performed by, or under the complete direction and control of 7.0 g of cocoa butter was then added to the above mixture inventor and board certified dermatologist and cosmetic Sur in the drum while a temperature ranging from about 75°C. to geon Joel Schlessinger, MD, FAAD, FAACS with patients about 85°C. was maintained. Mixing was continued for about having various skin maladies under confidential conditions 30 minutes, which was sufficient to completely dissolve the and circumstances in order to determine the efficacy of these cocoa butter therein. compositions generally, and under different conditions, using 11.0 g of Finsolv TN was then added to the above mixture different application rates and/or different application in the drum while a temperature ranging from about 75°C. to devices, to treat different medical skin disorders (cuts, cracks, about 85°C. was maintained. Mixing was continued for a peeling, eczema, rashes, irritation, dryness, excessive dryness period of about 30 minutes, which was sufficient to com and inflammation), and as applied to different body parts 25 pletely dissolve the Finsolv TN therein. (lips, cheeks, chin, face, fingers, hands and/or arms) of dif The above mixture was mixed for an additional period of ferent human beings (those of different ages and sexes, and about 30-60 minutes, which was sufficient to cause any having different weights), and in comparison with different remaining particles present therein be completely dissolved control or known compositions. in the mixture, while a temperature ranging from about 75° C. 30 to about 85°C. was maintained. EXAMPLE1 The resulting mixture was then permitted to cool naturally to a temperature ranging from about 55° C. to about 60° C. Preparation of a Hydrocortisone Composition 1.0 g of hydrocortisone was then added to the above mix (Including Vanilla Flavoring) ture and mixed therewith until it dissolved therein, which took 35 about 30 minutes, while maintaining the temperature of the mixture ranging from about 55° C. to about 60° C. Initial Formulation The resulting mixture was then permitted to cool naturally A batch of a vanilla-flavored hydrocortisone-containing to a temperature ranging from about 50° C. to about 55° C. topical skin formulation of the present invention in the form and then 0.5g of vanilla flavoring was added to the mixture. ofa roll-up balm was prepared in the manner described below, 40 The vanilla flavoring was mixed with the mixture for about and designated as batch LTC#6-47 AHV. The composition 15-20 minutes, which was sufficient to incorporate it evenly contained the components, and weight percents thereof, that throughout the mixture, while maintaining a temperature ranging from about 50° C. to about 55° C. are set forth below. The resulting mixture was liquid in nature, light yellow in 45 color, and had a general appearance of a thin milky liquid. A sample of this mixture was analyzed using High Performance Ingredient Weight Percent Liquid Chromatography (HPLC) to determine the weight Hydrocortisone 1.O percentage of hydrocortisone in the mixture, which was FANCOLVEB 11.0 determined to be 1 weight percent. (Gas chromatography Natunola Castor 1023 18.0 50 (GS) may also be used to perform this function.) Finsolv TN 11.0 Once the sample was found to be acceptable (i.e., to pos BeeSWax 2O.O Castor Oil 11.5 sess the above characteristics), the entire batch of the com Stearyl Alcohol 2O.O position was transferred to a filler assembly line, where it was Cocoa Butter 7.0 manually poured into individual plastic container molds to Flavoring (Vanilla) O.S 55 form Stick-shaped roll-up skin balms measuring about 5.5 cm in length and about 1.5 cm in diameter. TOTAL 100 After the compositions settled and hardened in the contain ers, which generally took about 60 minutes, a plastic con 11.5g of castor oil was added to a standard stainless steel tainer cap was placed onto the open end of each container. drum including a mixer and heated using a standard hot plate 60 (While not done with respect to the skin balms described in to a temperature ranging from about 75° C. to about 85°C., this example, a label including a batch code (or other infor while stirring it continuously using the mixer. mation) may be placed onto one or a plurality of the container 11.0 g of FANCOL VB was added to the castor oil in the tubes.) drum, and mixed with the castor oil until it was completely Several other forms of a topical hydrocortisone-containing dissolved therein, which took about 30 minutes, while main 65 composition, but not including the particular ingredients that taining a temperature ranging from about 75° C. to about are described herein, or the particular percent weights 85o C. thereof, were also produced in the same, or a similar, manner US 8,685,381 B2 95 96 as is described above. Many of these forms were not deemed Example 1, with the exception that this batch did not include to be acceptable because they were too thick (and did not any flavoring or any hydrocortisone. To compensate for the spread well on the skin), too bitter tasting, ineffective in absence of the 0.5 weight percent flavoring and the 1.0 weight improving, repairing and/or healing one or more skin condi percent hydrocortisone in this batch, additional castor oil was tions or maladies and/or exhibited one or more other unac employed, bringing the total weight percent of castor oil up to ceptable characteristics. For example, samples designated as 13%. This batch of the formulation was designated as batch 6-25A, 6-25B, 6-26A, 6-26B, 6-16C, 5-22-004, 5-22-005, LTC#6-47A, and contained the components, and weight per 5-22-006, 5-22-007, 5-22-008, 5-22-009, 5-22-010 and 6-16, cents thereof, that are set forth below. as well as others, were all deemed to be inferior or not accept able (i.e., they did not include one or more (or all) of the beneficial characteristics that are described herein). It was 10 also determined that hydrocortisone containing compositions Ingredient Weight Percent and base formulations that did not include the ingredient Hydrocortisone O.O Finsolv TN exhibited a problem with consistency over time as FANCOLVEB 11.0 they deteriorated overtime, thereby producing an undesirable Natunola Castor 1023 18.0 gritty consistency. Finsolv TN is, thus, an important ingredi 15 Finsolv TN 11.0 ent for inclusion in the hydrocortisone-containing and other BeeSWax 2O.O Castor Oil 13.0 active-agent containing compositions and base formulations Stearyl Alcohol 2O.O of the invention. Cocoa Butter 7.0 After many different topical hydrocortisone-containing Flavoring (Vanilla) O.O formulations were produced, and after a very significant amount of experimentation and testing of the same on human TOTAL 100 beings, it was determined that the topical hydrocortisone containing composition, and related base compositions, that include the particular ingredients that are described herein, EXAMPLE 4 and the particular percent weights thereof have the very ben 25 eficial and advantageous characteristics that are described Testing of Hydrocortisone Composition Prepared in herein. Example 1 on Forearm, Wrist and Face of a EXAMPLE 2 Sixteen-Year-Old Male Patient Having Eczema Preparation of a Hydrocortisone Composition (not 30 In the three topical skin treatment experiments that are Including Flavoring) described below, a hydrocortisone formulation prepared as described in Example 1 in a form of a large solid stick was Initial Formulation applied to various areas of the skin of a sixteen-year-old male patient at varying application rates (of about 0.5 ml/applica A batch of the same formulation that is described in 35 tion), as is described below, using a roll-up applicator, as is Example 1 was prepared in the same manner as is described in shown in FIG.1. These experiments were conducted by Joel Example 1, with the exception that this batch did not include Schlessinger, M.D., FAAD, FAACS, aboard certified derma any flavoring. To compensate for the absence of the 0.5 tologist and cosmetic Surgeon. weight percent flavoring in this batch, additional castor oil In a first experiment, the composition was applied to the was employed, bringing the total weight percent of castor oil 40 left forearm of the male patient, who had eczema on this up to 12 weight percent. This batch of the formulation was forearm. FIGS. 2 and 3 are photographs showing the left designated as batch LTC#6-47 AH, and contained the com forearm of the patient (with eczema) as the forearm existed ponents, and weight percents thereof, that are set forth below. prior to receiving any type of treatment for the eczema. FIGS. 2 and 3 show the forearm having two plaques (elevated, solid, 45 Superficial lesions greater than 0.5 cm in diameter) present in Ingredient Weight Percent the skin of the forearm. FIG. 5 is a photograph showing the same forearm that is shown in FIGS. 2 and 3, but as the Hydrocortisone 1.O forearm existed after being treated only with the hydrocorti FANCOLVEB 11.0 Sone-containing composition of the invention, with twenty Natunola Castor 1023 18.0 Finsolv TN 11.0 50 applications of the composition being applied to the forearm BeeSWax 2O.O spaced equally apart over a period of seven days. FIG. 5 Castor Oil 12.0 shows that the two eczema plaques that are present on the Stearyl Alcohol 2O.O Cocoa Butter 7.0 forearm shown in FIGS. 2 and 3 completely disappeared after Flavoring (Vanilla) O.O such treatment (i.e., the skin on the forearm was fully healed). 55 In a second experiment, the composition was applied to the TOTAL 100 left wrist of the same male patient, who had eczema on this wrist. FIG. 4 is a photograph showing the left wrist of the patient (with eczema) as the wrist existed prior to receiving EXAMPLE 3 any type of treatment for the eczema. FIG. 5 is a photograph 60 showing the same wrist that is shown in FIG. 4, but as the Preparation of a Base Composition (not Including wrist existed after being treated only with the hydrocortisone Flavoring or Hydrocortisone) containing composition of the invention, with thirty applica tions of the composition being applied to the wrist spaced Initial Formulation equally apart over a period of seven days. FIG. 5 shows that 65 the eczema that is present on the wrist in FIG. 4 completely A batch of the same formulation that is described in disappeared after Such treatment (i.e., the skin on the wrist Example 1 was prepared in the same manner as is described in was fully healed). US 8,685,381 B2 97 98 In a third experiment, the composition was applied to the formulation, stating that it healed the eczematous area on face of the same male patient, who had very dry lips, as well her cheek. The composition was applied over a four-month as eczema on the chin. FIG. 6 is a photograph showing the full period and two to three times daily. face of the patient (with dry lips and eczema on the chin) as Patient Designated “LLH. Female, Age 28: Tested the for the face existed prior to receiving any type of treatment for the mulation on her fingers and subsequently stated, “While it is a bit waxy in feeling, it was a rather clean appearance dry lips and eczema on the chin. FIG. 7 is a photograph while doing magic for my condition on fingers. The com showing the chin area (with eczema) of the same face that is position was applied over a two-month period and two shown in FIG. 6 (i.e., a view that is closer up). FIG. 8 is a times daily. photograph showing the same face that is shown in FIG. 6 Patient Designated “MW, Male, Age 22: Tested the formu (including the same chin that is shown in FIG. 7), but as the 10 lation on his lips for excessive dryness and Subsequently face (and chin) existed after being treated only with the stated, “I have been using the lip balm and it seems to be hydrocortisone-containing composition of the invention, working. The composition was applied over a three with ten applications of the composition being applied to the month period and four times daily on average. face (including the lips and chin) spaced equally apart over a Patient Designated “JB.. Male, Age 25: Tested the formula period of seven days. FIG. 8 shows that the eczema on the 15 tion on her face for facial dryness and Subsequently stated, chin in FIGS. 6 and 7 completely disappeared (i.e., the skin on “I have been using it. It works very well. The composition the chin was fully healed), and that the lips no longer were dry. was applied over a three-month period and twice daily. Patient Designated “EC. Female, Age 78: Tested the formu EXAMPLE 5 lation on her lips for irritation and subsequently stated, “No irritation of lips now.” The composition was applied overa Testing of Hydrocortisone Composition Prepared in six-month period and six times daily. Example 1 on Various Body Parts Patient Designated “DS.” Male, Age 16: Tested the formula tion on his fingers, hands, cheeks, chin, lips and arms in (Face, Cheeks, Chin, Lips, Fingers, Hands or Arms) connection with rashes and subsequently stated, “Worked of Eleven Other Patients Having Different Skin 25 wonderfully on my fingers, hands, cheeks, chin, lips and arms to clear up rashes. The composition was applied over Disorders (Eczema, Cuts, Cracks, Peeling, Rashes, an eight-month period and approximately four times daily Irritation or Excessive Dryness) for the lips and chin and three times daily for the body and hands. In the topical skin treatment testing experiments that are Patient Designated “JHS. Female, Age 76: Tested the for described below, a hydrocortisone formulation of the inven 30 mulation on her fingers in connection with dry skin and tion, prepared as is described in Example 1, and in a form of cuts and Subsequently stated, “Liked the taste, and it was a solid stick, was applied to various areas of the skin of eleven especially helpful for my dry skin on the fingers and cuts.” other human beings (patients) in varying quantities and at The composition was applied over a four-month period varying application rates, as is described below, using a roll twice daily for the lips and fingers. up applicator, as is shown in FIG.1. Detailed patient feedback 35 Patient Designated “JS. Male, Age 50: Tested the formula was subsequently provided to Joel Schlessinger, M.D., tion on his fingers in connection with dry skin and Subse FAAD, FAACS, aboard certified dermatologist and cosmetic quently stated, “This worked very nicely for me and helped Surgeon, who oversaw each of these experiments, and is my fingers when they were dry.” The composition was described below. applied over a nine-month period twice daily. The test subjects used for these studies were both male and 40 Patient Designated “SH. Female, Age 35: Tested the formu female patients ranging from sixteen to seventy-eightyears of lation on her dry lips and Subsequently stated, "I was strug age. gling with my lips becoming so dry. I told you about my A control formulation was also employed in Some of these concerns, dry, peeling, and my bottom lip would crack in studies. The control product was a formulation described in the middle, it was very painful. You had me test your trial U.S. Pat. No. 6.228,351 in most cases or an “over-the 45 lip balm, and I absolutely loved it, and still love it. I would counter (non-prescription) lip balm or medication that was put it on at night for bedtime, and after two applications my prescription in nature (i.e., prescribed by a medical doctor). lips were soft and perfect.” The composition was applied Initial applications of the hydrocortisone formation, and of over a five-month period at approximately twice daily. the control formulation, topically to the skin of the test sub Patient Designated “RMS. Female, Age 26: Tested the for jects, and instructions for Subsequent applications, were 50 mulation on her dry hands and Subsequently stated, "It supervised by Joel Schlessinger, M.D., FAAD, FAACS. worked really well. I was having pretty significant cracking A variety of application procedures were employed with due to the dry air and repeated hand washing. It was thick respect to number of applications of a test material and dura and protective and helped to heal the areas faster than any tion of applications in an attempt to reflect actual real world moisturizers I had tried. It was nice also to just put it on the usage of these types of products, as well as to determine the 55 trouble areas and not have a thick product over my entire extent to which observed results were a function of duration hands. The composition was applied over a four-month and/or frequency of use. The application protocols (fre period, using it three times daily on the areas. quency and duration of use) varied as is discussed below. Each test Subject applied the hydrocortisone formulation, and EXAMPLE 6 separately the control, to the areas of his or her lips or body 60 that are described below. Preparation of Another Hydrocortisone Composition Patient Designated “TS. Age 17, Male: Tested the formula (Including Vanilla Flavoring) tion on his lips, and liked the formulation, stating that it helped his lips to heal. The composition was applied overa Improved Formulation OTC two-month period and approximately five times per day. 65 Patient Designated “KS Age 60. Female: Tested the formu A batch of a preferred OTC vanilla-flavored hydrocorti lation on an eczematous area on her cheek, and liked the Sone-containing topical skinformulation of the present inven US 8,685,381 B2 99 100 tion was prepared in the manner described below. The com 70° C. to about 80°C. was maintained. Mixing of the ingre position contained the components, and weight percents dients was then continued for about 15-20 minutes. thereof, that are set forth below. The resulting mixture was liquid in nature, light yellow in color, and had a general appearance of a thin milky liquid. Once the sample (mixture) was found to be acceptable (i.e., to possess the above characteristics), the entire batch of the Ingredient Weight Percent composition was transferred to the filling area, where it was Hydrocortisone 1.00 manually poured into the individual plastic containers to form FANCOLVEB 11.00 the following shapes and sizes: Natunola Castor 1023 1O.OO 10 FINSOLVTN 1S.OO (i) a 0.15 fluid ounce stick-shaped roll-up skin balm mea BeeSWax 11.00 Suring about 6.0 cm in length and about 1.5 cm in diam Castor Oil 24.50 Stearyl Alcohol 2O.OO eter (a suitable size for a lip balm); Cocoa Butter 7.00 (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm mea Vanilla Flavoring OSO 15 Suring about 7.6 cm in length and about 2.0 cm in diam eter (a suitable size for a body balm); and TOTAL 1OO (iii) a 0.25 fluid ounce jar-shaped skin balm measuring about 3.0 cm in length and about 3.3 cm in diameter (a 60.88 pounds of castor oil were added to a standard stain suitable size for a face balm). less steel drum including a mixer and heated using Heating After the compositions settled and hardened in the contain Bands (Expo Engineered Inc., Cicero, Ill.) to a temperature ers, which generally took about 60 minutes, a container cap ranging from about 75° C. to about 85°C., while stirring it made of plastic material was placed onto the open end of each continuously using the mixer. container and then a label including a batch code and expira 27.50 pounds of FANCOLVB were added to the castor oil tion date was placed onto either the label or the container. in the drum, and mixed with the castor oil until it was com 25 A sample of the finished product was then analyzed using pletely dissolved therein, which took about 30 minutes, while High Performance Liquid Chromatography (HPLC) or Gas maintaining a temperature ranging from about 75°C. to about Chromatography (GC) to detect the percentage of hydrocor 85o C. tisone for characteristics of one percent hydrocortisone. Also, 27.50 pounds of bees wax were then added to the above a sample of the finished product was tested to confirm its 30 compliance with an established U.S. specification for micro mixture of castor oil and FANCOLVB in the drum while a biological quality using the known USP Microbial Limits temperature ranging from about 75° C. to about 85°C. was Test, which is described in Chapter 61 and 62 of the U.S. maintained. Mixing of the ingredients was continued for Pharmacopeia (USP) for Microbial Limits, which is hereby about 30 minutes, which was sufficient to completely dissolve incorporated herein by reference in its entirety. the bees wax therein. 35 The topical skin formulation that was prepared in this 50.00 pounds of stearyl alcohol were then added to the example may be contained in Stick, jar, pot and/or other above mixture in the drum while a temperature ranging from suitable or desirable containers (of a wide variety of different about 75° C. to about 85°C. was maintained. Mixing was shapes, sizes and materials) including the above, or other continued for a period of about 30 minutes, which was suffi suitable or desirable, quantities thereof. cient to completely dissolve the stearyl alcohol therein. 40 17.50 pounds of cocoa butter were then added to the above EXAMPLE 7 mixture in the drum while a temperature ranging from about 75°C. to about 85°C. was maintained. Mixing was continued Preparation of another Hydrocortisone Composition for about 30 minutes, which was sufficient to completely (Not Including any Flavoring) dissolve the cocoa butter therein. 45 37.50 pounds of FINSOLV TN were then added to the Improved Formulation OTC above mixture in the drum while a temperature ranging from about 75° C. to about 85°C. was maintained. Mixing was A batch of another preferred OTC hydrocortisone skin continued for a period of about 30 minutes, which was suffi formulation of the present invention in the form of a roll-up cient to completely dissolve the FINS OLVTN therein. 50 balm was prepared in the manner described in Example 6, and 25.00 pounds of Natunola 1023 were added to the above designated as batch LTC#6-47 AH. This composition differed mixture in the drum while a temperature ranging from about from the composition described in Example 6 in that it did not 75°C. to about 85°C. was maintained. Mixing of the ingre include any flavoring. The composition contained the com dients was then continued for about 60 minutes. ponents, and weight percents thereof, that are set forth in The above mixture was mixed for an additional 30-60 55 Example 6, with the exceptions that no flavoring component minutes, which was Sufficient to have any remaining particles was included, and an additional 0.5 weight percent of Castor present therein to be completely dissolved in the mixture, Oil was included (in place of the 0.5 weight percent of fla while a temperature ranging from about 75°C. to about 85°C. Voring), as is shown below. was maintained. 2.88 pounds of hydrocortisone were then added to the 60 above mixture and mixed until it dissolved therein, which Ingredient Weight Percent took about 30 minutes, while maintaining the temperature of Hydrocortisone 1.OO the mixture ranging from about 75° C. to about 85°C. FANCOLVEB 11.00 The resulting mixture was then permitted to cool naturally Natunola Castor 1023 1O.OO to a temperature ranging from about 70° C. to about 80° C. 65 FINSOLVTN 1S.OO 1.25 pounds of vanilla flavoring were added to the above BeeSWax 11.00 mixture in the drum while a temperature ranging from about US 8,685,381 B2 102 -continued (iii) a 0.25 fluid ounce jar-shaped skin balm measuring about 3.0 cm in length and about 3.3 cm in diameter (a Ingredient Weight Percent suitable size for a face balm). Castor Oil 2S.OO After the compositions settled and hardened in the contain Stearyl Alcohol 2O.OO 5 ers, which generally took about 60 minutes, a container cap Cocoa Butter 7.00 made of plastic material was placed onto the open end of each TOTAL 1OO container and then a label including a batch code and expira tion date was placed onto either the label or the container. A sample of the finished product was then analyzed using 62.13 pounds of castor oil were added to a standard stain 10 High Performance Liquid Chromatography (HPLC) or Gas less steel drum including a mixer and heated using Heating Chromatography (GC) to detect the percentage of hydrocor Bands to a temperature ranging from about 75° C. to about tisone for characteristics of one percent hydrocortisone. Also, 85°C., while stirring it continuously using the mixer. a sample of the finished product was tested to confirm its 27.50 pounds of FANCOLVB were added to the castor oil compliance with an established U.S. specification for micro in the drum, and mixed with the castor oil until it was com 15 biological quality using the known USP Microbial Limits pletely dissolved therein, which took about 30 minutes, while Test. maintaining a temperature ranging from about 75°C. to about The topical skin formulation that was prepared in this 85o C. example may be contained in Stick, jar, pot and/or other 27.50 pounds of bees wax were then added to the above suitable or desirable containers (of a wide variety of different mixture of castor oil and FANCOLVB in the drum while a shapes, sizes and materials) including the above, or other temperature ranging from about 75° C. to about 85°C. was suitable or desirable, quantities thereof. maintained. Mixing of the ingredients was continued for about 30 minutes, which was sufficient to completely dissolve EXAMPLE 8 the bees wax therein. 25 Preparation of Another Base Composition (not 50.00 pounds of stearyl alcohol were then added to the Including Hydrocortisone, but Including Vanilla above mixture in the drum while a temperature ranging from Flavoring) about 75° C. to about 85°C. was maintained. Mixing was continued for a period of about 30 minutes, which was suffi Improved Formulation Non-OTC cient to completely dissolve the stearyl alcohol therein. 30 17.50 pounds of cocoa butter were then added to the above A batch of a preferred non-OTC, vanilla-flavored, topical mixture in the drum while a temperature ranging from about base composition of the present invention (not including 75°C. to about 85°C. was maintained. Mixing was continued hydrocortisone or any other active agent) was prepared in the for about 30 minutes, which was sufficient to completely manner described below. The base composition contained the dissolve the cocoa butter therein. 35 components, and weight percents thereof, that are set forth 37.50 pounds of FINSOLV TN were then added to the below. above mixture in the drum while a temperature ranging from about 75° C. to about 85°C. was maintained. Mixing was continued for a period of about 30 minutes, which was suffi cient to completely dissolve the FINSOLVTN therein. 40 Ingredient Weight Percent 25.00 pounds of Natunola 1023 were added to the above FANCOLVEB 11.00 Natunola Castor 1023 10.00 mixture in the drum while a temperature ranging from about FINSOLVTN 1S.OO 75°C. to about 85°C. was maintained. Mixing of the ingre BeeSWax 11.00 dients was then continued for about 60 minutes. Castor Oil 25.50 45 The above mixture was mixed for an additional 30-60 Stearyl Alcohol 2O.OO Cocoa Butter 7.00 minutes, which was Sufficient to have any remaining particles Vanilla Flavoring O.SO present therein to be completely dissolved in the mixture, while a temperature ranging from about 75°C. to about 85°C. TOTAL 1OO was maintained. 50 2.88 pounds of hydrocortisone were then added to the 63.75 pounds of castor oil were added to a standard stain above mixture and mixed until it dissolved therein, which less steel drum including a mixer and heated using Heating took about 30 minutes, while maintaining the temperature of Bands to a temperature ranging from about 75° C. to about the mixture ranging from about 75° C. to about 85°C. The 85°C., while stirring it continuously using the mixer. resulting mixture was liquid in nature, light yellow in color, 55 27.50 pounds of FANCOLVB were added to the castor oil and had a general appearance of a thin milky liquid. in the drum, and mixed with the castor oil until it was com Once the sample (mixture) was found to be acceptable (i.e., pletely dissolved therein, which took about 30 minutes, while to possess the above characteristics), the entire batch of the maintaining a temperature ranging from about 75°C. to about composition was transferred to the filling area, where it was 850 C. manually poured into the individual plastic containers to form 60 27.50 pounds of bees wax were then added to the above the following shapes and sizes: mixture of castor oil and FANCOLVB in the drum while a (i) a 0.15 fluid ounce stick-shaped roll-up skin balm mea temperature ranging from about 75° C. to about 85°C. was Suring about 6.0 cm in length and about 1.5 cm in diam maintained. Mixing of the ingredients was continued for eter (a suitable size for a lip balm); about 30 minutes, which was sufficient to completely dissolve (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm mea 65 the bees wax therein. Suring about 7.6 cm in length and about 2.0 cm in diam 50.00 pounds of stearyl alcohol were then added to the eter (a suitable size for a body balm); and above mixture in the drum while a temperature ranging from US 8,685,381 B2 103 104 about 75° C. to about 85°C. was maintained. Mixing was cortisone or any other active agent) was prepared in the man continued for a period of about 30 minutes, which was suffi ner described below. The base composition contained the cient to completely dissolve the stearyl alcohol therein. components, and weight percents thereof, that are set forth 17.50 pounds of cocoa butter were then added to the above below. mixture in the drum while a temperature ranging from about 75°C. to about 85°C. was maintained. Mixing was continued for about 30 minutes, which was sufficient to completely dissolve the cocoa butter therein. Ingredient Weight Percent 37.50 pounds of FINS OLV TN were then added to the above mixture in the drum while a temperature ranging from FANCOLVEB 11.00 10 Natunola Castor 1023 10.00 about 75° C. to about 85°C. was maintained. Mixing was FINSOLVTN 1S.OO continued for a period of about 30 minutes, which was suffi BeeSWax 11.00 cient to completely dissolve the FINSOLVTN therein. Castor Oil 26.00 25.00 pounds of Natunola 1023 were added to the above Stearyl Alcohol 2O.OO mixture in the drum while a temperature ranging from about Cocoa Butter 7.00 75°C. to about 85°C. was maintained. Mixing of the ingre 15 dients was then continued for about 60 minutes. TOTAL 1OO The above mixture was mixed for an additional 30-60 minutes, which was Sufficient to have any remaining particles 65.00 pounds of castor oil were added to a standard stain present therein to be completely dissolved in the mixture, less steel drum including a mixer and heated using Heating while a temperature ranging from about 75°C. to about 85°C. Bands to a temperature ranging from about 75° C. to about was maintained. The resulting mixture was then permitted to cool naturally 85°C., while stirring it continuously using the mixer. to a temperature ranging from about 70° C. to about 80° C. 27.50 pounds of FANCOLVB were added to the castor oil 1.25 pounds of vanilla flavoring were added to the above in the drum, and mixed with the castor oil until it was com mixture in the drum while a temperature ranging from about 25 pletely dissolved therein, which took about 30 minutes, while 70° C. to about 80°C. was maintained. Mixing of the ingre maintaining a temperature ranging from about 75°C. to about dients was then continued for about 15-20 minutes. 850 C. The resulting mixture was liquid in nature, light yellow in 27.50 pounds of bees wax were then added to the above color, and had a general appearance of a thin milky liquid. mixture of castor oil and FANCOLVB in the drum while a Once the sample (mixture) was found to be acceptable (i.e., temperature ranging from about 75° C. to about 85°C. was to possess the above characteristics), the entire batch of the 30 composition was transferred to the filling area, where it was maintained. Mixing of the ingredients was continued for manually poured into the individual plastic containers to form about 30 minutes, which was sufficient to completely dissolve the following shapes and sizes: the bees wax therein. (i) a 0.15 fluid ounce stick-shaped roll-up skin balm mea 50.00 pounds of stearyl alcohol were then added to the Suring about 6.0 cm in length and about 1.5 cm in diam 35 above mixture in the drum while a temperature ranging from eter (a suitable size for a lip balm); about 75° C. to about 85°C. was maintained. Mixing was (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm mea continued for a period of about 30 minutes, which was suffi Suring about 7.6 cm in length and about 2.0 cm in diam cient to completely dissolve the stearyl alcohol therein. eter (a suitable size for a body balm); and 17.50 pounds of cocoa butter were then added to the above (iii) a 0.25 fluid ounce jar-shaped skin balm measuring 40 mixture in the drum while a temperature ranging from about about 3.0 cm in length and about 3.3 cm in diameter (a 75°C. to about 85°C. was maintained. Mixing was continued suitable size for a face balm). for about 30 minutes, which was sufficient to completely After the compositions settled and hardened in the contain dissolve the cocoa butter therein. ers, which generally took about 60 minutes, a container cap 37.50 pounds of FINS OLV TN were then added to the made of plastic material was placed onto the open end of each 45 above mixture in the drum while a temperature ranging from container and then a label including a batch code and expira about 75° C. to about 85°C. was maintained. Mixing was tion date was placed onto either the label or the container. continued for a period of about 30 minutes, which was suffi A sample of the finished product was then analyzed using cient to completely dissolve the FINSOLVTN therein. High Performance Liquid Chromatography (HPLC) or Gas 25.00 pounds of Natunola 1023 were added to the above Chromatography (GC), and tested to confirm its compliance 50 mixture in the drum while a temperature ranging from about with an established U.S. specification for microbiological 75° C. to about 85°C. was maintained. Mixing of the ingre quality using the known USP Microbial Limits Test. dients was then continued for about 60 minutes. The base composition that was prepared in this example The above mixture was mixed for an additional 30-60 may be contained in Stick, jar, pot and/or other Suitable or minutes, which was Sufficient to have any remaining particles desirable containers (of a wide variety of different shapes, 55 present therein to be completely dissolved in the mixture, sizes and materials) including the above, or other Suitable or while a temperature ranging from about 75°C. to about 85°C. desirable, quantities thereof. was maintained. The resulting mixture was liquid in nature, light yellow in EXAMPLE 9 color, and had a general appearance of a thin milky liquid. 60 Once the sample (mixture) was found to be acceptable (i.e., Preparation of Another Base Composition (not to possess the above characteristics), the entire batch of the Including Hydrocortisone or any Flavoring) composition was transferred to the filling area, where it was manually poured into the individual plastic containers to form Improved Formulation Non-OTC the following shapes and sizes: 65 (i) a 0.15 fluid ounce stick-shaped roll-up skin balm mea A batch of a preferred non-OTC, unflavored, topical base Suring about 6.0 cm in length and about 1.5 cm in diam composition of the present invention (not including hydro eter (a suitable size for a lip balm); US 8,685,381 B2 105 106 (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm mea in FIG.9A are significantly moisturized and reduced, and that Suring about 7.6 cm in length and about 2.0 cm in diam the cuts that are shown in FIG. 9A have completely disap eter (a suitable size for a body balm); and peared (i.e., have a 100% improvement). (iii) a 0.25 fluid ounce jar-shaped skin balm measuring FIG. 10A shows the palmar aspect of the same left hand as about 3.0 cm in length and about 3.3 cm in diameter (a 5 it was present prior to receiving any type of treatment with a suitable size for a face balm). composition of the invention for the dryness, cracks, and cuts After the compositions settled and hardened in the contain appearing thereon, with an emphasis on the thumb and the ers, which generally took about 60 minutes, a container cap palm. FIG. 10B shows the same palm that is shown in FIG. made of plastic material was placed onto the open end of each 10A, but as the palm existed after being treated only with the container and then a label including a batch code and expira- 10 hydrocortisone-containing Solid composition (in the manner tion date was placed onto either the label or the container. described above). A comparison of the left hand that is shown A sample of the finished product was then analyzed using in FIG. 10A with the left hand that is shown in FIG. 10B High Performance Liquid Chromatography (HPLC) or Gas shows that the dryness and cracks that are shown in FIG. 10A Chromatography (GC), and tested to confirm its compliance are significantly moisturized and reduced, and that the cuts with an established U.S. specification for microbiological 15 that are shown in FIG. 10A have completely disappeared (i.e., quality using the known USP Microbial Limits Test. have a 100% improvement). The base composition that was prepared in this example FIG.11A shows the dorsal aspect of the right hand as it was may be contained in Stick, jar, pot and/or other Suitable or present prior to receiving any type of treatment with a com desirable containers (of a wide variety of different shapes, position of the invention for the dryness, cracks, and cuts sizes and materials) including the above, or other suitable or 20 appearing thereon, with an emphasis on the thumb, index desirable, quantities thereof. finger, and knuckles. FIG. 11B shows the same dorsal aspect that is shown in FIG. 11A, but as the hand existed after being EXAMPLE 10 treated only with the hydrocortisone-containing Solid com position (in the manner described above). A comparison of Testing of Hydrocortisone Composition Prepared in 25 the right hand that is shown in FIG. 11A with the right hand Example 6 on Left and Right Hands of that is shown in FIG. 11B shows that the dryness and cracks Fifty-Year-Old Female Patient Having Psoriasis that are shown in FIG. 11A are significantly moisturized and reduced, and that the cuts that are shown in FIG. 11A have In the topical skin treatment experiments that are described completely disappeared (i.e., have a 100% improvement). below, a hydrocortisone formulation prepared as described in 30 FIG. 12A shows the palmar aspect of the right hand as it Example 6 in a form of a large Solid stick (including approxi was present prior to receiving any type of treatment with a mately 14.78 ml of the formulation), was applied to the left composition of the invention for the dryness, cracks, and cuts and right hands (both sides of each hand) of a fifty-year-old appearing thereon, with an emphasis on the palm, thumb, and female patient having psoriasis, whose initials are PT, at an index finger. FIG.12B shows the same palm that is shown in application rate of about 100 applications of about 0.5 ml/ap- 35 FIG.12A, but as the palm existed after being treated only with plication of the composition being equally spaced apart over the hydrocortisone-containing Solid composition (in the man a period of 30 days (i.e., about 3-4 applications per day). ner described above). A comparison of the right hand that is These experiments were conducted by Joel Schlessinger, shown in FIG. 12A with the right hand that is shown in FIG. M.D., FAAD, FAACS, a board certified dermatologist and 12B shows that the dryness and cracks that are shown in FIG. cosmetic Surgeon. 40 12A are significantly moisturized and reduced, and that the Long prior to these experiments, this same female patient cuts that are shown in FIG. 12A have completely disappeared had tried to improve or eradicate the above-described skin (i.e., have a 100% improvement). disorders on her left and right hands using a wide variety of FIG. 13A shows the same dorsal aspects of the same left different known “over-the-counter (non-prescription) and and right hands, as they were present prior to receiving any prescription (prescribed by a medical doctor) topical skin 45 type of treatment with a composition of the invention for the products, including balms, and those including one or more dryness, cracks, and cuts appearing thereon, with an emphasis active agents, such as hydrocortisone. She tried numerous on the thumbs, index fingers, and knuckles of both hands. different forms of topical compositions including hydrocor FIG. 13B shows the same left and right hands that are shown tisone on her hands, as well as other, more powerful forms of in FIG. 13A, but as the left and right hands existed after being corticosteroids, oral medications and injectable medications. 50 treated only with the hydrocortisone-containing Solid com She, however, did not have success with any of these topical position (in the manner described above). A comparison of compositions or medications (i.e., her skin disorders were not the left and right hands that are shown in FIG. 13A with the significantly improved or eradicated by any of these compo left and right hands that are shown in FIG. 13B shows that the sitions or medications), as can clearly be seen in each of the dryness and cracks that are shown in FIG. 13A are signifi “before photographs that are shown in FIGS.9A, 10A, 11A, 55 cantly moisturized and reduced, and that the cuts that are 12A, 13A and 14A (photographs taken before the experi shown in FIG. 13A have completely disappeared (i.e., have a ments described in this example were preformed). 100% improvement). FIG. 9A shows the dorsal aspect of the left hand as it was FIG. 14A shows the same palmar aspects of the same left present prior to receiving any type of treatment with a com and right hands, as they were present prior to receiving any position of the invention for the dryness, cracks, and cuts 60 type of treatment with a composition of the invention for the appearing thereon, with an emphasis on the thumb and the dryness, cracks, and cuts appearing thereon, with an emphasis index finger. FIG. 9B shows the same dorsal aspect that is on the palms, thumbs, and index fingers of both hands. FIG. shown in FIG.9A, but as this hand existed after being treated 14B shows the same left and right hands that are shown in only with the hydrocortisone-containing solid composition FIG. 14A, but as the left and right hands existed after being (in the manner described above). A comparison of the left 65 treated only with a hydrocortisone-containing solid compo hand that is shown in FIG.9A with the left hand that is shown sition of the invention (in the manner described above). A in FIG.9B shows that the dryness and cracks that are shown comparison of the left and right hands that are shown in FIG. US 8,685,381 B2 107 108 14A with the left and right hands that are shown in FIG. 14B 16B shows that the seborrheic dermatitis, scaling and shows that the dryness and cracks that are shown in FIG. 14A erythema that is shown in FIG. 16A was significantly are significantly moisturized and reduced, and that the cuts reduced. that are shown in FIG. 14A have completely disappeared (i.e., have a 100% improvement). EXAMPLE 13 The experiments that are described in this example show the very significant advantages and benefits of hydrocorti Testing of Hydrocortisone Composition Prepared in Sone-containing topical compositions of the present inven Example 6 on Face of Seventeen-Year-Old Female tion, which were very efficacious in healing the above-de Patient Having Eczema scribed skin disorders, in comparison with other known 10 hydrocortisone-containing topical compositions, which were In the topical skin treatment experiments that are described not efficacious in healing the same skin disorders on the same below, a hydrocortisone formulation prepared as described in hands of the same patient. Example 6, and in a form of a small solid Stick having the 15 smaller size shown in FIG. 1, was applied to the face of a EXAMPLE 11 17-year-old female patient having eczema, whose initials are SR, at an application rate of 21 applications of about 0.1 Testing of Hydrocortisone Composition Prepared in ml/application of the composition being equally spaced apart Example 6 on Face of Thirty-Five-Year-Old Female over a period of 7 days (i.e., 3 applications per day). These Patient Having Seborrheic Dermatitis experiments were conducted by Joel Schlessinger, M.D., FAAD, FAACS, a board certified dermatologist and cosmetic In the topical skin treatment experiments that are described Surgeon. below, a hydrocortisone formulation prepared as described in FIG.17A shows this patient’s face as it was present prior to Example 6, and in a form of a small Solid Stick having the receiving any type of treatment for the eczema appearing smaller size shown in FIG. 1, was applied to the face of a 25 thereon. FIG. 17B shows the same face that is shown in FIG. thirty-five-year-old female patient having seborrheic derma 17A, but as the face existed after being treated only with the titis, whose initials are SN. at an application rate of 21 appli hydrocortisone-containing Solid composition (in the manner cations of about 0.1 ml/application of the composition being described above). A comparison of the face that is shown in equally spaced apart over a period of 7 days (i.e., 3 applica FIG. 17A with the face that is shown in FIG. 17B shows that tions per day). These experiments were conducted by Joel 30 the eczema that is shown in FIG. 17A was significantly Schlessinger, M.D., FAAD, FAACS, aboard certified derma reduced (reduced by about 80%). tologist and cosmetic Surgeon. FIG.15A shows this patient’s face as it was present prior to EXAMPLE 1.4 receiving any type of treatment for the erythema of the 35 Testing of Hydrocortisone Composition Prepared in nasolabial folds appearing thereon. FIG. 15B shows the same Example 6 on Hands of Fifty-Three-Year-Old face that is shown in FIG. 15A, but as the face existed after being treated only with the hydrocortisone-containing Solid Female Patient Having Eczema composition (in the manner described above). A comparison In the topical skin treatment experiments that are described of the face that is shown in FIG. 15A with the face that is 40 below, a hydrocortisone formulation prepared as described in shown in FIG. 15B shows that the scaling and erythema that Example 6, and in a form of a small solid Stick having the is shown in FIG. 15A was significantly reduced. smaller size shown in FIG. 1, was applied to the hands of a 53-year-old female patient with initials PR for eczema that a EXAMPLE 12 steriod ointment was unable to completely clear. Specifically, 45 18 applications of about 0.1 ml/application of the composi Testing of Hydrocortisone Composition Prepared in tion were applied to each hand, the applications being equally Example 6 on Face of Forty-One-Year-Old Male spaced apart over a period of 9 days (i.e., 2 applications per Patient Having Seborrheic Dermatitis day per hand). These experiments were conducted by Joel Schlessinger, M.D., FAAD, FAACS, aboard certified derma In the topical skin treatment experiments that are described 50 tologist and cosmetic Surgeon. below, a hydrocortisone formulation prepared as described in FIG. 18A shows this patient’s left hand as it was present Example 6, and in a form of a small Solid Stick having the prior to receiving any type of treatment for the eczema smaller size shown in FIG. 1, was applied to the face of a appearing thereon just below the base of the ring finger. FIG. forty-one-year-old male patient having seborrheic dermatitis, 18B shows the same hand that is shown in FIG. 18A, but as the whose initials are JT, at an application rate of 21 applications 55 hand existed after being treated only with the hydrocortisone of about 0.1 ml/application of the composition being equally containing solid composition (in the manner described spaced apart over a period of 7 days (i.e., 3 applications per above). A comparison of the hand that is shown in FIG. 18A day). These experiments were conducted by Joel with the hand that is shown in FIG. 18B shows that the eczema Schlessinger, M.D., FAAD, FAACS, aboard certified derma that is shown in FIG. 18A had completely cleared (i.e., a tologist and cosmetic Surgeon. 60 100% improvement). Similarly, FIG. 19A shows this FIG.16A shows this patient’s face as it was present prior to patient's right hand as it was present prior to receiving any receiving any type of treatment for the seborrheic dermatitis type of treatment for the eczema appearing thereon at the base appearing thereon. FIG. 16B shows the same face that is of the fourth finger. FIG. 19B shows the same hand that is shown in FIG.16A, but as the face existed after being treated shown in FIG. 19A, but as the hand existed after being treated only with the hydrocortisone-containing solid composition 65 only with the hydrocortisone-containing solid composition (in the manner described above). A comparison of the face (in the manner described above). A comparison of the hand that is shown in FIG. 16A with the face that is shown in FIG. that is shown in FIG. 19A with the hand that is shown in FIG. US 8,685,381 B2 109 110 19B shows that the eczema that is shown in FIG. 19A had tion does not have a bitter taste or odor, has no distinctive taste completely cleared (i.e., a 100% improvement). or odor or has a pleasant taste or odor. While the present invention has been described herein with 4. A topical base composition in a solid or semi-solid form specificity, and with reference to certain preferred embodi for use as a carrier vehicle for one or a plurality of active ments thereof, those of ordinary skill in the art will recognize agents, comprising (i) 11.00 weight percent Limnanthes Alba numerous variations, modifications and Substitutions of that (Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea But which has been described which can be made, and which are ter) Extract, (ii) 10.00 weight percent Ricinus Communis within the scope and spirit of the invention. It is intended that (Castor) Seed Oil (and) Glycine Soja (Soybean) Germ. Extract all of these modifications and variations be within the scope (and) Zea Mays (Corn) Starch (and) Silica, (iii) 15.00 weight of the present invention as described and claimed herein, and 10 that the invention be limited only by the scope of the claims percent Cas Alkyl Benzoate, (iv) 11.00weight percent Bees which follow, and that such claims be interpreted as broadly Wax, (v) 26.00 weight percent Castor Oil, (vi) 20.00 weight as is reasonable. percent Stearyl Alcohol, (vii) 7.00 weight percent Cocoa Throughout this document, various books, patents, patent Butter, and (viii) 0.00 weight percent Flavoring (Vanilla), applications, journal articles, web sites and other publications 15 wherein the base composition has an ability to function effec have been cited. The entireties of each of these books, patents, tively as a topically-applied carrier vehicle for the active patent applications, journal articles, web sites and other pub agents, and wherein the base composition is effective in pro lications are hereby incorporated by reference herein. moting or causing a penetration of the active agents within What is claimed is: one or more layers, tissues, or layers and tissues, of skin of a 1. A topical base composition in a Solid or semi-solid form mammal that is damaged, injured, diseased or has an inflam for use as a carrier vehicle for one or a plurality of active matory reaction or condition. agents, consisting of (i) Limnanthes Alba (Meadowfoam) 5. A topical base composition in a solid or semi-solid form Seed Oil, Butyrospermum Parkii (Shea Butter) Extract, (ii) for use as a carrier vehicle for one or a plurality of active Ricinus Communis (Castor) Seed Oil (and) Glycine Soja agents, consisting of: (Soybean) Germ. Extract (and) Zea Mays (Corn) Starch (and) 25 (a) Limnanthes Alba (Meadowfoam) Seed Oil. Butyrosper Silica, (iii) Cas Alkyl Benzoate, and (iv) bees wax, each in mum Parkii (Shea Butter) Extract, wherein the Limnan amounts that are effective for collectively forming a base thes Alba (Meadowfoam) Seed Oil, Butyrospermum composition having an ability to function effectively as a Parkii (Shea Butter) Extract is present in the base com topically-applied carrier vehicle for the active agents, position in an amount ranging from about 6 to about 25 wherein the base composition is effective in promoting or 30 weight percent; causing a penetration of the active agents within one or more (b) Ricinus Communis (Castor) Seed Oil (and) Glycine layers, tissues, or layers and tissues, of skin of a mammal that Soia (Soybean) Germ Extract (and) Zea Mays (Corn) is damaged, injured, diseased or has an inflammatory reaction Starch (and) Silica, wherein the Ricinus Communis or condition. (Castor) Seed Oil (and) Glycine Soia (Soybean) Germ 2. A topical base composition in a Solid or semi-solid form 35 Extract (and) Zea Mays (Corn) Starch (and) Silica is for use as a carrier vehicle for one or a plurality of active present in the base composition in an amount ranging agents, consisting of (i) Limnanthes Alba (Meadowfoam) from about 5 to about 39 weight percent; Seed Oil, Butyrospermum Parkii (Shea Butter) Extract, (ii) (c) Cas Alkyl Benzoate, wherein the Cas Alkyl Ben Ricinus Communis (Castor) Seed Oil (and) Glycine Soja Zoate is present in the base composition in an amount (Soybean) Germ. Extract (and) Zea Mays (Corn) Starch (and) 40 ranging from about 9 to about 25 weight percent; Silica, (iii) Cas Alkyl Benzoate, and (iv) beeswax, and one (d) bees wax, wherein the bees wax is present in the base or a plurality of plant oils, plant seed oils, fatty alcohols or composition in an amount ranging from about 6 to about fats, or any combination thereof, each in combined amounts 43 weight percent; that are effective for collectively forming a base composition (e) optionally, one or a plurality of plant oils or plant seed having an ability to function effectively as a topically-applied 45 oils, wherein the plant oils or plant seed oils are present carrier vehicle for the active agents, wherein the base com in the base composition in a combined amount ranging position is effective in promoting or causing a penetration of from about 0 to about 38.5 weight percent; the active agents within one or more layers, tissues, or layers (f) optionally, one or a plurality of fatty alcohols, wherein and tissues, of skin of a mammal that is damaged, injured, the fatty alcohols are present in the base composition in diseased or has an inflammatory reaction or condition. 50 a combined amount ranging from about 0 to about 25 3. A topical base composition in a Solid or semi-solid form weight percent; for use as a carrier vehicle for one or a plurality of active (g) optionally, one or a plurality of fats, wherein the fats are agents, consisting of (i) Limnanthes Alba (Meadowfoam) present in the base composition in a combined amount Seed Oil, Butyrospermum Parkii (Shea Butter) Extract, (ii) ranging from about 0 to about 12 weight percent; and Ricinus Communis (Castor) Seed Oil (and) Glycine Soja 55 (h) optionally, one or a plurality of flavorings, wherein the (Soybean) Germ. Extract (and) Zea Mays (Corn) Starch (and) flavorings are present in the base composition in a com Silica, (iii) Cas Alkyl Benzoate, and (iv) beeswax, and one bined amount ranging from about 0 to about 3.5 weight or a plurality of flavorings, and one or a plurality of plant oils, percent; plant seed oils, fatty alcohols or fats, or any combination wherein the base composition has an ability to function effec thereof, each in combined amounts that are effective for col 60 tively as a topically-applied carrier vehicle for the active lectively forming a base composition having an ability to agents, and wherein the base composition is effective in pro function effectively as a topically-applied carrier vehicle for moting or causing a penetration of the active agents within the active agents, wherein the base composition is effective in one or more layers, tissues, or layers and tissues, of skin of a promoting or causing a penetration of the active agents within mammal that is damaged, injured, diseased or has an inflam one or more layers, tissues, or layers and tissues, of skin of a 65 matory reaction or condition. mammal that is damaged, injured, diseased or has an inflam 6. A base composition of claim 5, wherein the base com matory reaction or condition, and wherein the base composi position includes one or more flavorings. US 8,685,381 B2 111 112 7. A topical base composition in a Solid or semi-solid form (e) one or more plant oils or plant seed oils, wherein the for use as a carrier vehicle for one or a plurality of active plant oils or plant seed oils are present in the base com agents, consisting of: position in a combined amount ranging from about 13 to (a) Limnanthes Alba (Meadowfoam) Seed Oil, Butyrosper about 38.5 weight percent; mum Parkii (Shea Butter) Extract, wherein the Limnan (f) one or more fatty alcohols, wherein the fatty alcohols thes Alba (Meadowfoam) Seed Oil, Butyrospermum are present in the base composition in a combined Parkii (Shea Butter) Extract is present in the base com amount ranging from about 15 to about 25 weight per position in an amount ranging from about 6 to about 25 cent; weight percent; (g) one or more fats, wherein the fats are present in the base (b) Ricinus Communis (Castor) Seed Oil (and) Glycine 10 Soia (Soybean) Germ Extract (and) Zea Mays (Corn) composition in a combined amount ranging from about Starch (and) Silica, wherein the Ricinus Communis 2 to about 12 weight percent; and (Castor) Seed Oil (and) Glycine Soia (Soybean) Germ (h) optionally, one or more flavorings, wherein the flavor Extract (and) Zea Mays (Corn) Starch (and) Silica is ings are present in the base composition in an amount present in the base composition in an amount ranging 15 ranging from about 0 to about 3.5 weight percent; from about 5 to about 39 weight percent; wherein the base composition has an ability to function effec (c) Cas Alkyl Benzoate, wherein the Cas Alkyl Ben tively as a topically-applied carrier vehicle for the active Zoate is present in the base composition in an amount agents, and wherein the base composition is effective in pro ranging from about 9 to about 25 weight percent; moting or causing a penetration of the active agents within (d) bees wax, wherein the bees wax is present in the base one or more layers, tissues, or layers and tissues, of skin of a composition in an amount ranging from about 6 to about mammal that is damaged, injured, diseased or has an inflam 43 weight percent; matory reaction or condition. (e) one or more plant oils or plant seed oils, wherein the 10. A base composition of claim 9, wherein the base com plant oils or plant seed oils are present in the base com position includes one or more flavorings. positionina combined amount ranging from about 0.1 to 25 11. A topical base compositionina Solid or semi-solid form about 38.5 weight percent; for use as a carrier vehicle for one or a plurality of active (f) one or more fatty alcohols, wherein the fatty alcohols agents, consisting of: are present in the base composition in a combined (a) Limnanthes Alba (Meadowfoam) Seed Oil. Butyrosper amount ranging from about 0.1 to about 25 weight per mum Parkii (Shea Butter) Extract, wherein the Limnan cent; 30 thes Alba (Meadowfoam) Seed Oil, Butyrospermum (g) one or more fats, wherein the fats are present in the base Parkii (Shea Butter) Extract is present in the base com composition in a combined amount ranging from about position in an amount ranging from about 10 to about 12 0.1 to about 12 weight percent; and weight percent; (h) optionally, one or more flavorings, wherein the flavor (b) Ricinus Communis (Castor) Seed Oil (and) Glycine ings are present in the base composition in an amount 35 Soia (Soybean) Germ Extract (and) Zea Mays (Corn) ranging from about 0 to about 3.5 weight percent; Starch (and) Silica, wherein the Ricinus Communis wherein the base composition has an ability to function effec (Castor) Seed Oil (and) Glycine Soia (Soybean) Germ tively as a topically-applied carrier vehicle for the active Extract (and) Zea Mays (Corn) Starch (and) Silica is agents, and wherein the base composition is effective in pro present in the base composition in an amount ranging moting or causing a penetration of the active agents within 40 from about 9 to about 11 weight percent; one or more layers, tissues, or layers and tissues, of skin of a (c) Cas Alkyl Benzoate, wherein the Cas Alkyl Ben mammal that is damaged, injured, diseased or has an inflam Zoate is present in the base composition in an amount matory reaction or condition. ranging from about 14 to about 16 weight percent; 8. A base composition of claim 7, wherein the base com (d) bees wax, wherein the bees wax is present in the base position includes one or more flavorings. 45 composition in an amount ranging from about 10 to 9. A topical base composition in a solid or semi-solid form about 12 weight percent; for use as a carrier vehicle for one or a plurality of active (e) one or more plant oils or plant seed oils, wherein the agents, consisting of: plant oils or plant seed oils are present in the base com (a) Limnanthes Alba (Meadowfoam) Seed Oil, Butyrosper position in a combined amount ranging from about 24.5 mum Parkii (Shea Butter) Extract, wherein the Limnan 50 to about 27 weight percent; thes Alba (Meadowfoam) Seed Oil, Butyrospermum (f) one or more fatty alcohols, wherein the fatty alcohols Parkii (Shea Butter) Extract is present in the base com are present in the base composition in a combined position in an amount ranging from about 6 to about 16 amount ranging from about 19 to about 21 weight per weight percent; cent; (b) Ricinus Communis (Castor) Seed Oil (and) Glycine 55 (g) one or more fats, wherein the fats are present in the base Soia (Soybean) Germ Extract (and) Zea Mays (Corn) composition in a combined amount ranging from about Starch (and) Silica, wherein the Ricinus Communis 6 to about 8 weight percent; and (Castor) Seed Oil (and) Glycine Soia (Soybean) Germ (h) optionally, one or more flavorings, wherein the flavor Extract (and) Zea Mays (Corn) Starch (and) Silica is ings are present in the base composition in an amount present in the base composition in an amount ranging 60 ranging from about 0 to about 3.5 weight percent; from about 5 to about 15 weight percent; wherein the base composition has an ability to function effec (c) Cas Alkyl Benzoate, wherein the Cas Alkyl Ben tively as a topically-applied carrier vehicle for the active Zoate is present in the base composition in an amount agents, and wherein the base composition is effective in pro ranging from about 10 to about 20 weight percent; moting or causing a penetration of the active agents within (d) bees wax, wherein the bees wax is present in the base 65 one or more layers, tissues, or layers and tissues, of skin of a composition in an amount ranging from about 6 to about mammal that is damaged, injured, diseased or has an inflam 16 weight percent; matory reaction or condition. US 8,685,381 B2 113 114 12. A base composition of claim 11, wherein the base Parkii (Shea Butter) Extract is present in the composi composition includes one or more flavorings. tion in an amount ranging from about 6 to about 25 13. A base composition of claim 5, wherein the plant oil or weight percent; plant seed oil is castor oil, the fatty alcohol is stearyl alcohol (c) Ricinus Communis (Castor) Seed Oil (and) Glycine or the fat is cocoa butter, or any combination thereof. Soia (Soybean) Germ Extract (and) Zea Mays (Corn) 14. A base composition of claim 6, wherein the plant oil or Starch (and) Silica, wherein the Ricinus Communis plant seed oil is castor oil, the fatty alcohol is stearyl alcohol (Castor) Seed Oil (and) Glycine Soia (Soybean) Germ or the fat is cocoa butter, or any combination thereof. Extract (and) Zea Mays (Corn) Starch (and) Silica is 15. A base composition of claim 7, wherein the plant oil or present in the composition in an amount ranging from 10 about 5 to about 39 weight percent; plant seed oil is castor oil, the fatty alcohol is stearyl alcohol (d) Cas Alkyl Benzoate, wherein the C2-s Alkyl Ben or the fat is cocoa butter, or any combination thereof. Zoate is present in the composition in an amount ranging 16. A base composition of claim 8, wherein the plant oil or from about 9 to about 25 weight percent; plant seed oil is castor oil, the fatty alcohol is stearyl alcohol (e) bees wax, wherein the bees wax is present in the com or the fat is cocoa butter, or any combination thereof. 15 position in an amount ranging from about 6 to about 43 17. A base composition of claim 9, wherein the plant oil or weight percent; plant seed oil is castor oil, the fatty alcohol is stearyl alcohol (f) optionally, one or a plurality of plant oils or plant seed or the fat is cocoa butter, or any combination thereof. oils, wherein the plant oils or plant seed oils are present 18. Abase composition of claim 10, wherein the plant oil or in the composition in a combined amount ranging from plant seed oil is castor oil, the fatty alcohol is stearyl alcohol about 0 to about 37.5 weight percent; or the fat is cocoa butter, or any combination thereof. (g) optionally, one or a plurality of fatty alcohols, wherein 19. Abase composition of claim 11, wherein the plant oil or the fatty alcohols are present in the composition in a plant seed oil is castor oil, the fatty alcohol is stearyl alcohol combined amount ranging from about 0 to about 25 or the fat is cocoa butter, or any combination thereof. weight percent; 20. A base composition of claim 12, wherein the plant oil or 25 (h) optionally, one or a plurality of fats, wherein the fats are plant seed oil is castor oil, the fatty alcohol is stearyl alcohol present in the composition in a combined amount rang or the fat is cocoa butter, or any combination thereof. ing from about 0 to about 12 weight percent; and 21. A composition in a solid or semi-solid form for topical (i) optionally, one or a plurality of flavorings, wherein the application to the skin of a mammal for repairing, improving flavorings are present in the composition in a combined or fully healing a skin disorder, disease, adverse condition, or 30 amount ranging from about 0 to about 3.5 weight per other condition that requires, or could benefit from, improve Cent, ment, or for causing the mammal’s skinto experience a reduc wherein the composition is effective in repairing, improving tion in pain, Soreness or itchiness, or a combination thereof, or fully healing skin of the mammal that is damaged, injured, comprising (i) 1.0 weight percent Hydrocortisone, (ii) 11.00 diseased, has an inflammatory reaction or condition, or weight percent Limnanthes Alba (Meadowfoam) Seed Oil, 35 requires, or could benefit from, improvement, or in causing Butyrospermum Parkii (Shea Butter) Extract, (iii) 10.00 the mammal’s skinto experience a reduction in pain, Soreness weight percent Ricinus Communis (Castor) Seed Oil (and) or itchiness, or a combination thereof, and wherein the com Glycine Soia (Soybean) Germ Extract (and) Zea Mays (Corn) position has an ability to act within one or more layers, Starch (and) Silica, (iv) 15.00 weight percent Cls Alkyl tissues, or layers and tissues, of the skin of the mammal that Benzoate, (v) 11.00 weight percent Bees Wax: (vi) 24.50 40 is damaged, injured, diseased, has an inflammatory reaction weight percent Castor Oil, (vii) 20.00 weight percent Stearyl or condition, or requires, or could benefit from, improvement. Alcohol, (viii) 7.00 weight percent Cocoa Butter, and (ix) 23. A composition of claim 22, wherein the composition 0.50 weight percent Flavoring (Vanilla), wherein the compo includes one or more flavorings. sition is effective in repairing, improving or fully healing skin 24. A composition of claim 22, wherein the active agent is of the mammal that is damaged, injured, diseased, has an 45 hydrocortisone. inflammatory reaction or condition, or requires, or could ben 25. A composition of claim 23, wherein the active agent is efit from, improvement, or in causing the mammal’s skin to hydrocortisone. experience a reduction in pain, Soreness or itchiness, or a 26. A composition in a solid or semi-solid form for topical combination thereof, and wherein the composition has an application to the skin of a mammal for repairing, improving ability to act within one or more layers, tissues, or layers and 50 or fully healing a skin disorder, disease, adverse condition, or tissues, of the skin of the mammal that is damaged, injured, other condition that requires, or could benefit from, improve diseased, has an inflammatory reaction or condition, or ment, or for causing the mammal’s skinto experience a reduc requires, or could benefit from, improvement. tion in pain, Soreness or itchiness, or a combination thereof, 22. A composition in a solid or semi-solid form for topical consisting of: application to the skin of a mammal for repairing, improving 55 (a) one or a plurality of active agents, wherein the active or fully healing a skin disorder, disease, adverse condition, or agents are present in the composition in a combined other condition that requires, or could benefit from, improve amount ranging from about 0.1 to about 5 weight per ment, or for causing the mammal’s skinto experience a reduc cent; tion in pain, Soreness or itchiness, or a combination thereof, (b) Limnanthes Alba (Meadowfoam) Seed Oil, Butyrosper consisting of: 60 mum Parkii (Shea Butter) Extract, wherein the Limnan (a) one or a plurality of active agents, wherein the active thes Alba (Meadowfoam) Seed Oil, Butyrospermum agents are present in the composition in a combined Parkii (Shea Butter) Extract is present in the composi amount ranging from about 0.1 to about 5 weight per tion in an amount ranging from about 6 to about 25 cent; weight percent; (b) Limnanthes Alba (Meadowfoam) Seed Oil, Butyrosper 65 (c) Ricinus Communis (Castor) Seed Oil (and) Glycine mum Parkii (Shea Butter) Extract, wherein the Limnan Soia (Soybean) Germ Extract (and) Zea Mays (Corn) thes Alba (Meadowfoam) Seed Oil, Butyrospermum Starch (and) Silica, wherein the Ricinus Communis US 8,685,381 B2 115 116 (Castor) Seed Oil (and) Glycine Soia (Soybean) Germ (d) Cas Alkyl Benzoate, wherein the C2-s Alkyl Ben Extract (and) Zea Mays (Corn) Starch (and) Silica is Zoate is present in the composition in an amount ranging present in the composition in an amount ranging from from about 10 to about 20 weight percent; about 5 to about 39 weight percent; (e) bees wax, wherein the bees wax is present in the com (d) Cas Alkyl Benzoate, wherein the Cls Alkyl Ben position in an amount ranging from about 6 to about 16 Zoate is present in the composition in an amount ranging weight percent; from about 9 to about 25 weight percent; (f) one or a plurality of plant oils or plant seed oils, wherein (e) bees wax, wherein the bees wax is present in the com the plant oils or plant seed oils are present in the com position in an amount ranging from about 6 to about 43 position in a combined amount ranging from about 12 to weight percent; 10 about 37.5 weight percent; (g) one or a plurality of fatty alcohols, wherein the fatty (f) one or a plurality of plant oils or plant seed oils, wherein alcohols are present in the composition in a combined the plant oils or plant seed oils are present in the com amount ranging from about 15 to about 25 weight per positionina combined amount ranging from about 0.1 to cent; about 37.5 weight percent; 15 (h) one or a plurality of fats, wherein the fats are present in (g) one or a plurality of fatty alcohols, wherein the fatty the composition in a combined amount ranging from alcohols are present in the composition in a combined about 2 to about 12 weight percent; and amount ranging from about 0.1 to about 25 weight per (i) optionally, one or a plurality of flavorings, wherein the cent; flavorings are present in the composition in a combined (h) one or a plurality of fats, wherein the fats are present in amount ranging from about 0 to about 2.5 weight per the composition in a combined amount ranging from Cent, about 0.1 to about 12 weight percent; and wherein the composition is effective in repairing, improving (i) optionally, one or a plurality of flavorings, wherein the or fully healing skin of the mammal that is damaged, injured, flavorings are present in the composition in a combined diseased, has an inflammatory reaction or condition, or amount ranging from about 0 to about 3.5 weight per 25 requires, or could benefit from, improvement, or in causing Cent, the mammal’s skinto experience a reduction in pain, Soreness wherein the composition is effective in repairing, improving or itchiness, or a combination thereof, and wherein the com or fully healing skin of the mammal that is damaged, injured, position has an ability to act within one or more layers, diseased, has an inflammatory reaction or condition, or tissues, or layers and tissues, of the skin of the mammal that requires, or could benefit from, improvement, or in causing 30 is damaged, injured, diseased, has an inflammatory reaction or condition, or requires, or could benefit from, improvement. the mammal’s skin to experience a reduction in pain, Soreness 31. A composition of claim 30, wherein the composition or itchiness, or a combination thereof, and wherein the com includes one or more flavorings. position has an ability to act within one or more layers, 32. A composition of claim 30, wherein the active agent is tissues, or layers and tissues, of the skin of the mammal that 35 hydrocortisone. is damaged, injured, diseased, has an inflammatory reaction 33. A composition of claim 31, wherein the active agent is or condition, or requires, or could benefit from, improvement. hydrocortisone. 27. A composition of claim 26, wherein the composition 34. A composition in a solid or semi-solid form for topical includes one or more flavorings. application to the skin of a mammal for repairing, improving 28. A composition of claim 26, wherein the active agent is 40 or fully healing a skin disorder, disease, adverse condition, or hydrocortisone. other condition that requires, or could benefit from, improve 29. A composition of claim 27, wherein the active agent is ment, or for causing the mammal’s skinto experience a reduc hydrocortisone. tion in pain, Soreness or itchiness, or a combination thereof, 30. A composition in a solid or semi-solid form for topical consisting of: application to the skin of a mammal for repairing, improving 45 (a) one or a plurality of active agents, wherein the active or fully healing a skin disorder, disease, adverse condition, or agents are present in the composition in a combined other condition that requires, or could benefit from, improve amount ranging from about 0.8 to about 2 weight per ment, or for causing the mammal’s skinto experience a reduc cent; tion in pain, Soreness or itchiness, or a combination thereof, (b) Limnanthes Alba (Meadowfoam) Seed Oil, Butyrosper consisting of: 50 mum Parkii (Shea Butter) Extract, wherein the Limnan (a) one or a plurality of active agents, wherein the active thes Alba (Meadowfoam) Seed Oil, Butyrospermum agents are present in the composition in a combined Parkii (Shea Butter) Extract is present in the composi amount ranging from about 0.5 to about 3 weight per tion in an amount ranging from about 10 to about 12 cent; weight percent; (b) Limnanthes Alba (Meadowfoam) Seed Oil, Butyrosper 55 (c) Ricinus Communis (Castor) Seed Oil (and) Glycine mum Parkii (Shea Butter) Extract, wherein the Limnan Soia (Soybean) Germ Extract (and) Zea Mays (Corn) thes Alba (Meadowfoam) Seed Oil, Butyrospermum Starch (and) Silica, wherein the Ricinus Communis Parkii (Shea Butter) Extract is present in the composi (Castor) Seed Oil (and) Glycine Soia (Soybean) Germ tion in an amount ranging from about 6 to about 16 Extract (and) Zea Mays (Corn) Starch (and) Silica is weight percent; 60 present in the composition in an amount ranging from (c) Ricinus Communis (Castor) Seed Oil (and) Glycine about 9 to about 11 weight percent; Soia (Soybean) Germ Extract (and) Zea Mays (Corn) (d) Cas Alkyl Benzoate, wherein the C2-s Alkyl Ben Starch (and) Silica, wherein the Ricinus Communis Zoate is present in the composition in an amount ranging (Castor) Seed Oil (and) Glycine Soia (Soybean) Germ from about 14 to about 16 weight percent; Extract (and) Zea Mays (Corn) Starch (and) Silica is 65 (e) bees wax, wherein the bees wax is present in the com present in the composition in an amount ranging from position in an amount ranging from about 10 to about 12 about 5 to about 15 weight percent; weight percent; US 8,685,381 B2 117 118 (f) one or a plurality of plant oils or plant seed oils, wherein 50. A topical base composition in a solidorsemi-solid form the plant oils or plant seed oils are present in the com for use as a carrier vehicle for one or a plurality of active position in a combined amount ranging from about 23.5 agents, comprising (i) 11.00 weight percent Limnanthes Alba to about 26 weight percent; (Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea But (g) one or a plurality of fatty alcohols, wherein the fatty ter) Extract, (ii) 10.00 weight percent Ricinus Communis alcohols are present in the composition in a combined (Castor) Seed Oil (and) Glycine Soja (Soybean) Germ. Extract amount ranging from about 19 to about 21 weight per (and) Zea Mays (Corn) Starch (and) Silica, (iii) 15.00 weight cent; percent C2s Alkyl Benzoate, (iv) 11.00 weight percent (h) one or a plurality of fats, wherein the fats are present in Bees Wax, (v) 25.50 weight percent Castor Oil, (vi) 20.00 the composition in a combined amount ranging from 10 weight percent Stearyl Alcohol, (vii) 7.00 weight percent about 6 to about 8 weight percent; and Cocoa Butter, and (viii) 0.50 weight percent Flavoring (Va.- (i) optionally, one or a plurality of flavorings, wherein the nilla), wherein the base composition has an ability to function flavorings are present in the composition in a combined effectively as a topically-applied carrier vehicle for the active amount ranging from about 0.3 to about 1.5 weight agents, and wherein the base composition is effective in pro percent, 15 moting or causing a penetration of the active agents within wherein the composition is effective in repairing, improving one or more layers, tissues, or layers and tissues, of skin of a or fully healing skin of the mammal that is damaged, injured, mammal that is damaged, injured, diseased or has an inflam diseased, has an inflammatory reaction or condition, or matory reaction or condition. requires, or could benefit from, improvement, or in causing 51. A composition in a solid or semi-solid form for topical the mammal’s skinto experience a reduction in pain, Soreness application to the skin of a mammal for repairing, improving or itchiness, or a combination thereof, and wherein the com or fully healing a skin disorder, disease, adverse condition, or position has an ability to act within one or more layers, other condition that requires, or could benefit from, improve tissues, or layers and tissues, of the skin of the mammal that ment, or for causing the mammal’s skinto experience a reduc is damaged, injured, diseased, has an inflammatory reaction tion in pain, Soreness or itchiness, or a combination thereof, or condition, or requires, or could benefit from, improvement. 25 comprising (i) 1.0 weight percent Hydrocortisone, (ii) 11.00 35. A composition of claim 34, wherein the composition weight percent Limnanthes Alba (Meadowfoam) Seed Oil, includes one or more flavorings. Butyrospermum Parkii (Shea Butter) Extract, (iii) 10.00 36. A composition of claim 34, wherein the active agent is weight percent Ricinus Communis (Castor) Seed Oil (and) hydrocortisone. Glycine Soia (Soybean) Germ Extract (and) Zea Mays (Corn) 37. A composition of claim 36, wherein the active agent is 30 Starch (and) Silica, (iv) 15.00 weight percent Cls Alkyl hydrocortisone. Benzoate, (v) 11.00 weight percent Bees Wax, (vi) 25.00 38. A composition of claim 26, wherein the plant oil or weight percent Castor Oil, (vii) 20.00 weight percent Stearyl plant seed oil is castor oil, the fatty alcohol is stearyl alcohol Alcohol, (viii) 7.00 weight percent Cocoa Butter, and (ix) or the fat is cocoa butter, or any combination thereof. 0.00 weight percent Flavoring (Vanilla), wherein the compo 39. A composition of claim 27, wherein the plant oil or 35 sition is effective in repairing, improving or fully healing skin plant seed oil is castor oil, the fatty alcohol is stearyl alcohol of the mammal that is damaged, injured, diseased, has an or the fat is cocoa butter, or any combination thereof. inflammatory reaction or condition, or requires, or could ben 40. A composition of claim 28, wherein the plant oil or efit from, improvement, or in causing the mammal’s skin to plant seed oil is castor oil, the fatty alcohol is stearyl alcohol experience a reduction in pain, Soreness or itchiness, or a or the fat is cocoa butter, or any combination thereof. 40 combination thereof, and wherein the composition has an 41. A composition of claim 29, wherein the plant oil or ability to act within one or more layers, tissues, or layers and plant seed oil is castor oil, the fatty alcohol is stearyl alcohol tissues, of the skin of the mammal that is damaged, injured, or the fat is cocoa butter, or any combination thereof. diseased, has an inflammatory reaction or condition, or 42. A composition of claim 30, wherein the plant oil or requires, or could benefit from, improvement. plant seed oil is castor oil, the fatty alcohol is stearyl alcohol 45 52. A composition of claim 21, claim 22, claim 23, claim or the fat is cocoa butter, or any combination thereof. 26, claim 27, claim30, claim31, claim 34, claim35, claim38, 43. A composition of claim 31, wherein the plant oil or claim 39, claim 42, claim 43, claim 46, claim 47 or claim 51, plant seed oil is castor oil, the fatty alcohol is stearyl alcohol wherein one of the active agents is selected from the group or the fat is cocoa butter, or any combination thereof. consisting of clobetasol propionate 0.05%; betamethasone 44. A composition of claim 32, wherein the plant oil or 50 dipropionate 0.25%: halobetasol proprionate 0.05%; diflo plant seed oil is castor oil, the fatty alcohol is stearyl alcohol rasone diacetate 0.05%; fluocinonide 0.05%; halcinonide or the fat is cocoa butter, or any combination thereof. 0.05%; amcinonide 0.05%; desoximetasone 0.25%; triamci 45. A composition of claim 33, wherein the plant oil or nolone acetonide: 0.5%: mometasone furoate 0.1%; flutica plant seed oil is castor oil, the fatty alcohol is stearyl alcohol sone propionate 0.005%; betamethasone dipropionate or the fat is cocoa butter, or any combination thereof. 55 0.05%; fluocinolone acetonide 0.01-0.2%; hydrocortisone 46. A composition of claim 34, wherein the plant oil or Valerate 0.2%; hydrocortisone butyrate 0.1%; flurandrenolide plant seed oil is castor oil, the fatty alcohol is stearyl alcohol 0.05%; triamcinolone acetonide 0.1%; triamcinolone or the fat is cocoa butter, or any combination thereof. acetonide 0.1%; fluticasone propionate 0.05%; desonide 47. A composition of claim 35, wherein the plant oil or 0.05%; fluocinolone acetonide 0.025%: hydrocortisone val plant seed oil is castor oil, the fatty alcohol is stearyl alcohol 60 erate 0.2%; prednicarbate 0.05%; triamcinolone acetonide or the fat is cocoa butter, or any combination thereof. 0.025%; fluocinolone acetonide 0.01%; desonide 0.05%; 48. A composition of claim 36, wherein the plant oil or hydrocortisone 2.5%: hydrocortisone 1%; topical erythromy plant seed oil is castor oil, the fatty alcohol is stearyl alcohol cin; topical mupirocin, topical retapamulin; topical bacitra or the fat is cocoa butter, or any combination thereof. cin/polymyxin B; topical bacitracin/neomycin/polymyxin B; 49. A composition of claim 37, wherein the plant oil or 65 topical Sulfacetamide Sodium/urea; natamycin; rimocidin; plant seed oil is castor oil, the fatty alcohol is stearyl alcohol filipin, nystatin; amphotericin B; candicin; hamycin; micona or the fat is cocoa butter, or any combination thereof. Zole; miconazole nitrate; ketoconazole; clotrimazole; econa US 8,685,381 B2 119 120 Zole; bifonazole; butoconazole; fenticonazole; isoconazole; nophen, caffeine, and codeine; hydrocodone and ibuprofen; oxiconazole; Sertaconazole; Sulconazole; tioconazole; flu pentazocine/naloxone; acetaminophen and codeine; dihydro conazole; itraconazole; isaVuconazole; ravuconazole; posa codeine, acetaminophen, and caffeine; hydrocodone and conazole; Voriconazole; terconazole; abafungin; terbinafine; acetaminophen; oxycodone and acetaminophen; pentazocine naftifine; butenafine; anidulafungin; caspofungin: micafun and acetaminophen; propoxyphene and acetaminophen; aspi gin, polygodial; ciclopiroX, ciclopiroX olamine; tolnaftate; rin, caffeine and dihydrocodeine; aspirin and codeine; hydro undecylenic acid; flucytosine; 5-fluorocytosine; griseofulvin; codone and aspirin; oxycodone and aspirin; pentazocine and haloprogin; Sodium bicarbonate; pimecrolimus 1% Cream; aspirin; propoxyphene, aspirin, and caffeine; capsaicin; ben tacrolimus 0.1% ointment; clemastine; diphenhydramine; Zocaine; benzocaine/menthol: dibucaine; lidocaine; doxylamine; loratadine, desloratadine; fexofenadine; phe 10 lidocaine/prilocaine; onabotulinumtoxin.A.; abobotulinum niramine; cetirizine; ebastine; promethazine; chlorphe toxin.A., incobotulinumtoxin.A., botulinum toxin type A, niramine; levocetirizine, olopatadine; quetiapine; meclizine; DEET (N,N-diethyl-m-toluamide); essential oil; icaridin; dimenhydrinate; embramine; dimethindene; dexchlorphe nepetalactone; citronella oil; permethrin, neem oil; bog niramine; vitamin C. cimetidine; famotidine, ranitidine; niza myrtle: 3-N-Butyl-N-acetyl-aminopropionic acid, ethyl tidine; roxatidine; lafutidine; ciproxifan; clobempropit; thio 15 ester, p-aminobenzoic acid; padimate O; phenylbenzimida peramide; cromoglicate; nedocromil, a 132 adrenergic Zole Sulfonic acid, cinoxate; dioxybenzone; oxybenzone; agonist; acetaminophen; diclofenac; diflunisal; etodolac, homosalate; menthyl anthranilate; octocrylene; octyl meth fenoprofen; flurbiprofen; ibuprofen; indomethacin; ketopro oxycinnamate; octyl salicylate; Sulisobenzone; trolamine fen, ketorolac, meclofenamate; mefenamic acid; meloxicam, salicylate; avobenzone, ecamSule; titanium dioxide; Zinc nabumetone; naproxen; oxaprozin, phenylbutaZone; piroxi oxide: 4-methylbenzylidene camphor; bisoctrizole; bis-eth cam; Sulindac; tolmetin; celecoxib; buprenorphine; butorpha ylhexyloxyphenol methoxyphenyl triazine; disodium phenyl nol; codeine; hydrocodone; hydromorphone; levorphanol: dibenzimidazole tetrasulfonate; drometrizole trisiloxane: meperidine; methadone; morphine; nalbuphine; oxycodone; benzophenone-9; ethylhexyl triazone; diethylamino oxymorphone; pentazocine; propoxyphene; tramadol; trama hydroxybenzoyl hexyl benzoate; iscotrizinol; polysilicone dol and acetaminophen; butalbital, acetaminophen, and caf 25 15; and isopentenyl-4-methoxycinnamate. feine; butalbital, aspirin, and caffeine; butalbital, acetami k k k k k