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Home , Chlorobutanol, Creosote, Guaiacolsulfonate, Nitromersol, Quinine, Sodium tartrate

Food and Drug Administration, HHS § 310.545

201(p) of the Federal Food, Drug, and Benzocaine Cosmetic Act (the act), for which an Benzoic acid approved application or abbreviated Boric acid application under section 505 of the act Calcium polysulfide Calcium thiosulfate and part 314 of this chapter is required for marketing. In the absence of an ap- proved new drug application or abbre- Cloxyquin viated new drug application, such prod- Coal uct is also misbranded under section Dibenzothiophene 502 of the act. Estrone (c) Clinical investigations designed Magnesium aluminum silicate to obtain evidence that any drug prod- Magnesium uct labeled, represented, or promoted Phenolate sodium for OTC use as a deterrent is Phenyl salicylate safe and effective for the purpose in- Povidone- tended must comply with the require- Pyrilamine maleate ments and procedures governing the Resorcinol (as single ingredient) use of investigational new drugs set Resorcinol monoacetate (as single ingre- forth in part 312 of this chapter. dient) (d) After May 7, 1991, any such OTC Salicylic acid (over 2 up to 5 percent) drug product containing , cori- Sodium borate Sodium thiosulfate ander, , ginger (Ja- Tetracaine hydrochloride maica), lemon oil (terpeneless), licorice extract, , methyl salicy- Vitamin E late, ascorbate, nitrate, oxide and/or thymol initially introduced or Zinc stearate initially delivered for introduction into Zinc sulfide interstate commerce that is not in (2) Anticaries drug products—(i) Ap- compliance with this section is subject proved as of May 7, 1991. to regulatory action. After December 1, 1993, any such OTC drug product con- Hydrogen fluoride taining lobeline (in the form of lobeline Sodium carbonate Sodium monofluorophosphate (6 percent sulfate or natural lobelia or rinse) Lobelia inflata herb), povidone-silver ni- Sodium phosphate trate, silver acetate, or any other in- gredients initially introduced or ini- (ii) Approved as of October 7, 1996. tially delivered for introduction into Calcium sucrose phosphate interstate commerce that is not in Dicalcium phosphate dihydrate compliance with this section is subject Disodium hydrogen phosphate 1 to regulatory action. Phosphoric acid 1 Sodium dihydrogen phosphate [58 FR 31241, June 1, 1993] Sodium dihydrogen phosphate monohydrate Sodium phosphate, dibasic anhydrous rea- § 310.545 Drug products containing gent 1 certain active ingredients offered over-the-counter (OTC) for certain (3) Antidiarrheal drug products—(i) Ap- uses. proved as of May 7, 1991. (a) A number of active ingredients Aluminum hydroxide have been present in OTC drug prod- sulfate ucts for various uses, as described Calcium carbonate below. However, based on evidence cur- Carboxymethylcellulose sodium rently available, there are inadequate data to establish general recognition of Homatropine methylbromide Hyoscyamine sulfate the safety and effectiveness of these in- Lactobacillus acidophilus gredients for the specified uses: Lactobacillus bulgaricus (1) Topical acne drug products. Alcloxa 1 These ingredients are nonmonograph ex- Alkyl isoquinolinium cept when used to prepare acidulated phos- Aluminum chlorohydrex phate fluoride treatment rinses identified in Aluminum hydroxide § 355.10(a)(3) of this chapter.

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Opium, powdered Thymol tincture Thymol (lozenge) Paregoric Thymol (mouthwash) Phenyl salicylate oil hydrobromide Zinc phenolsulfonate (B) Approved as of August 23, 1995. (ii) Approved as of April 19, 2004; April Bornyl acetate (topical) Cedar leaf oil (topical) 18, 2005, for products with annual sales , beechwood (topical) less than $25,000. Ephedrine (oral) Attapulgite, activated Ephedrine hydrochloride (oral) Bismuth subnitrate Ephedrine sulfate (oral) Calcium hydroxide Racephedrine hydrochloride (oral/topical) Calcium polycarbophil (C) Approved as of April 11, 2007; Oc- Charcoal (activated) tober 11, 2007, for products with annual Pectin sales less than $25,000. Any ingre- Polycarbophil Potassium carbonate dient(s) labeled with claims or direc- Rhubarb fluidextract tions for use for sinusitis or for relief of nasal congestion associated with si- (4) Antiperspirant drug products—(i) nusitis. Ingredients—Approved as of May 7, 1991. (iii) Expectorant drug products. Alum, potassium Ammonium chloride Aluminum bromohydrate Antimony potassium Aluminum chloride (alcoholic solutions) Beechwood creosote Aluminum chloride (aqueous solution) (aer- preparations (compound tincture of osol only) benzoin, tincture of benzoin) Aluminum sulfate Camphor Aluminum sulfate, buffered (aerosol only) Sodium aluminum chlorohydroxy lactate /eucalyptus oil (ii) Approved as of December 9, 2004; Horehound Iodides (calcium iodide anyhydrous, hydroid- June 9, 2005, for products with annual ic acid syrup, iodized lime, potassium io- sales less than $25,000. dide) Aluminum sulfate buffered with sodium alu- Ipecac minum lactate Ipecac fluidextract Ipecac syrup (5) [Reserved] Menthol/peppermint oil (6) Cold, cough, allergy, bronchodilator, tar preparations (extract white pine and antiasthmatic drug products—(i) compound, , syrup of pine tar, com- drug products—(A) Ingre- pound white pine syrup, white pine) Potassium guaiacolsulfonate dients. Sodium citrate hydrochloride Squill preparations (squill, squill extract) Methapyrilene fumarate hydrate preparations (terpin hydrate, Thenyldiamine hydrochloride terpin hydrate elixir) Tolu preparations (tolu, tolu balsam, tolu (B) Ingredients. balsam tincture) Turpentine oil (spirits of turpentine) Phenyltoloxamine dihydrogen citrate Methapyrilene hydrochloride (iv) Bronchodilator drug products—(A) Methapyrilene fumarate Approved as of October 2, 1987. Thenyldiamine hydrochloride Aminophylline (ii) Nasal decongestant drug products— Belladonna alkaloids (A) Approved as of May 7, 1991. Euphorbia pilulifera Metaproterenol sulfate Allyl isothiocyanate Methoxyphenamine hydrochloride Camphor (lozenge) Pseudoephedrine hydrochloride Creosote, beechwood (oral) Pseudoephedrine sulfate Eucalyptol (lozenge) Theophylline, anhydrous Eucalyptol (mouthwash) Theophylline calcium salicylate Eucalyptus oil (lozenge) Theophylline sodium glycinate Eucalyptus oil (mouthwash) Menthol (mouthwash) (B) Approved as of January 29, 1996. Peppermint oil (mouthwash) Any combination drug product con- Thenyldiamine hydrochloride taining theophylline (e.g., theophylline

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and ephedrine, or theophylline and Pepsin ephedrine and ). (C) Approved as of June 19, 1996. Any Sodium citrate ingredient(s) in a pressurized metered- dose inhaler container. (ii) Approved as of November 10, 1993. (D) Approved as of October 29, 2001. Any oral bronchodilator active ingre- Aluminum hydroxide dient (e.g., ephedrine, ephedrine hydro- Amylase chloride, ephedrine sulfate, Anise seed racephedrine hydrochloride, or any Aromatic powder other ephedrine salt) in combination Asafetida with any analgesic(s) or analgesic-anti- Aspergillus oryza enzymes (except lactase enzyme derived from Aspergillus oryzae) pyretic(s), , antihis- Bacillus acidophilus tamine, oral antitussive, or stimulant Bean active ingredient. Belladonna alkaloids (7) Dandruff/seborrheic dermatitis/psori- Belladonna leaves, powdered extract asis drug products. Betaine hydrochloride Bismuth subcarbonate Alkyl isoquinolinium bromide Bismuth subgallate Allantoin Black radish powder Blessed thistle (cnicus benedictus) Buckthorn Boric acid Calcium gluconate Calcium undecylenate Capsicum Captan Capsicum, fluid extract of Chloroxylenol Carbon Colloidal oatmeal Cascara sagrada extract , saponated Catechu, tincture Ethohexadiol Catnip Eucalyptol Chamomile flowers Juniper tar Charcoal, wood Lauryl isoquinolinium bromide Chloroform Menthol oil oleate Cinnamon tincture Methylbenzethonium chloride Citrus pectin Methyl salicylate Diastase Phenol Diastase malt Phenolate sodium Dog grass Pine tar Elecampane Povidone-iodine Resorcinol Fennel acid Sodium borate Galega Sodium salicylate Ginger Thymol Glycine Undecylenic acid Hydrastis canadensis (golden seal) (8) Digestive aid drug products—(i) Ap- Hectorite proved as of May 7, 1991. Horsetail Bismuth sodium tartrate Hydrastis fluid extract Calcium carbonate Hydrochloric acid Cellulase Iodine Dehydrocholic acid Iron ox bile Dihydroxyaluminum sodium carbonate Johnswort Duodenal substance Juniper Garlic, dehydrated Kaolin, colloidal hydrochloride Knotgrass Hemicellulase Lactic acid Homatropine methylbromide Lactose Lavender compound, tincture of Magnesium trisilicate Linden Ox bile extract Lipase Pancreatin Lysine hydrochloride Pancrelipase Papain Mycozyme Peppermint oil , fluid extract of

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Nettle Eucalyptus oil Nickel-pectin Eugenol Nux vomica extract Glycol salicylate Orthophosphoric acid Hexylresorcinol Papaya, natural Histamine dihydrochloride Pectin Menthol (exceeding 1 percent) Peppermint Methapyrilene hydrochloride Peppermint spirit Methyl nicotinate Phenacetin Methyl salicylate Potassium bicarbonate Pectin Potassium carbonate Salicylamide Protease Strong ammonia solution Prolase Tannic acid Rhubarb fluid extract Thymol Senna Tripelennamine hydrochloride Sodium chloride Trolamine salicylate Sodium salicylate Turpentine oil Stem Zinc sulfate (vi) Insect bite and sting drug products. Tannic acid Alcohol Trillium Alcohol, ethoxylated alkyl Woodruff Benzalkonium chloride (iii) Charcoal, activated Calamine (9) [Reserved] Ergot fluidextract (10) External analgesic drug products— Ferric chloride (i) Analgesic and drug prod- Panthenol Peppermint oil ucts. Pyrilamine maleate Aspirin Sodium borate hydrate Trolamine salicylate Chlorobutanol Turpentine oil Cyclomethycaine sulfate Zinc oxide Eugenol Zirconium oxide Hexylresorcinol (vii) Poison ivy, poison , and poison Methapyrilene hydrochloride Salicylamide sumac drug products. Thymol Alcohol (ii) Counterirritant drug products. Aspirin Benzethonium chloride Benzocaine (0.5 to 1.25 percent) Eucalyptus oil Bithionol Calamine (iii) Male genital desensitizer drug Cetalkonium chloride products. Chloral hydrate Benzyl alcohol Chlorobutanol Camphorated metacresol Chlorpheniramine maleate Ephedrine hydrochloride Creosote, beechwood Cyclomethycaine sulfate (iv) Diaper rash drug products. Any in- Dexpanthenol gredient(s) labeled with claims or di- Diperodon hydrochloride rections for use in the treatment and/ Eucalyptus oil or prevention of diaper rash. Eugenol (v) blister and cold sore treatment Glycerin drug products. Glycol salicylate Hectorite Allyl isothiocyanate Hexylresorcinol Aspirin Bismuth sodium tartrate Impatiens biflora tincture Camphor (exceeding 3 percent) Iron oxide Capsaicin Capsicum Lanolin Capsicum oleoresin Lead acetate Chloral hydrate Chlorobutanol Mercuric chloride Cyclomethycaine sulfate Methapyrilene hydrochloride

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Panthenol (iv)(B) Stimulant —Approved Parethoxycaine hydrochloride as of January 29, 1999. Phenyltoloxamine dihydrogen citrate Povidone-vinylacetate copolymers Danthron Pyrilamine maleate Salicylamide Salicylic acid (C) Stimulant laxatives—Approved as of Simethicone November 5, 2002. Aloe ingredients (aloe, aloe extract, aloe Tannic acid flower extract) Thymol Cascara sagrada ingredients (casanthranol, Trolamine salicylate cascara fluidextract aromatic, cascara Turpentine oil sagrada , cascara sagrada extract, cas- Zirconium oxide cara sagrada fluidextract). Zyloxin (13) [Reserved] (11) [Reserved] (12) drug products—(i)(A) (14) Oral health care drug products Bulk laxatives. (nonantimicrobial). Agar Antipyrine Carrageenan (degraded) Camphor Carrageenan (native) Cresol Guar gun Dibucaine Dibucaine hydrochloride (i)(B) Bulk laxatives—Approved as of Eucalyptol March 29, 2007. Lidocaine Granular dosage forms containing psyllium Lidocaine hydrochloride (hemicellulose), psyllium hydrophilic Methly salicylate mucilloid, psyllium seed, psyllium seed Myrrh tincture (blond), psyllium seed husks, plantago Pyrilamine maleate husks, or plantago seed including, but not Sorbitol limited to, any granules that are: Sugars (1) Swallowed dry prior to drinking liquid, Tetracaine (2) Dispersed, suspended, or partially dis- Tetracaine hydrochloride solved in liquid prior to swallowing, Thymol (3) Chewed, partially chewed, or unchewed, and then washed down (or swallowed) with (15) Topical otic drug products—(i) For liquid, or the prevention of swimmer’s ear and for (4) Sprinkled over food. the drying of -clogged ears, ap- (ii) Saline laxative. proved as of May 7, 1991. Acetic acid (iii) Stool softener. (ii) For the prevention of swimmer’s ear, approved as of August 15, 1995. Poloxamer 188 Glycerin and anhydrous glycerin (iv)(A) Stimulant laxatives—Approved Isopropyl alcohol as of May 7, 1991. (16) Poison treatment drug products. Aloin Bile salts/acids Ipecac fluidextract Calcium pantothenate Ipecac tincture Calomel Zinc sulfate Colocynth Elaterin (17) Skin bleaching drug products. Frangula Mercury, ammoniated Ipomea (18) Skin protectant drug products— Jalap (i)(A) Ingredients—Approved as of May 7, Ox bile 1991. Podophyllum resin Prune concentrate dehydrate Allantoin (wound healing claims only) Prune powder Sulfur Rhubarb, Chinese Tannic acid Sodium Oleate Zinc acetate (wound healing claims only)

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(B) Ingredients—Approved as of June 4, hydrochloride 2004; June 6, 2005, for products with an- Glycerin nual sales less than $25,000. Protein hydrolysate Racemethionine Beeswax Sulfur Bismuth subnitrate Tannic acid Boric acid Zinc acetate Cetyl alcohol Zinc carbonate Glyceryl stearate Isopropyl palmitate (iv) Fever blister and cold sore treat- Live yeast cell derivative ment drug products. Shark oil Bismuth subnitrate Stearyl alcohol Boric acid (ii) Astringent drug products. Pyridoxine hydrochloride Sulfur Tannic acid Alcohol Topical starch Alum, ammonium Trolamine Alum, potassium Zinc sulfate Aluminum chlorhydroxy complex Aromatics (v) Insect bite and sting drug products— Benzalkonium chloride (A) Ingredients—Approved as of November Benzethonium chloride 10, 1993. Benzocaine Alcohol Benzoic acid Alcohol, ethoxylated alkyl Boric acid Ammonia solution, strong Calcium acetate (except calcium acetate Ammonium hydroxide monohydrate when combined with alu- Benzalkonium chloride minum sulfate tetradecahydrate to provide Camphor an aluminum acetate solution as described Ergot fluid extract in § 347.20(b) of this chapter) Ferric chloride Camphor gum Menthol oil Peppermint oil Colloidal oatmeal Phenol Cresol Pyrilamine maleate Cupric sulfate Sodium borate Eucalyptus oil Trolamine Eugenol Turpentine oil Ferric subsulfate (Monsel’s Solution) Zirconium oxide Isopropyl alcohol (B) Ingredients—Approved as of June 4, Menthol 2004; June 6, 2005, for products with an- Methyl salicylate nual sales less than $25,000. Oxyquinoline sulfate P-t-butyl-m-cresol Beeswax Peppermint oil Bismuth subnitrate Phenol Boric acid Polyoxeythylene laurate Cetyl alcohol Potassium ferrocyanide Glyceryl stearate Sage oil Isopropyl palmitate Live yeast cell derivative Sodium borate Shark liver oil Sodium diacetate Stearyl alcohol Talc (vi) Poison ivy, poison oak, and poison Tannic acid glycerite sumac drug products—(A) Ingredients— Thymol Topical starch Approved as of November 10, 1993. Zinc chloride Alcohol Zinc oxide Anion and cation exchange buffered Zinc phenolsulfonate Benzethonium chloride Zinc stearate Benzocaine Zinc sulfate Benzyl alcohol (iii) Diaper rash drug products. Bismuth subnitrate Bithionol Aluminum hydroxide Boric acid Camphor

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Cetalkonium chloride Calcium pantothenate Chloral hydrate Carboxymethylcellulose sodium Chlorpheniramine maleate Carrageenan Creosote Cholecalcierol Diperodon hydrochloride Choline hydrochloride Chondrus Eucalyptus oil Citric acid Ferric chloride Cnicus benedictus Glycerin Copper Hectorite Copper gluconate Hydrogen peroxide Corn oil Impatiens biflora tincture Corn syrup Iron oxide Corn silk, potassium extract Isopropyl alcohol Cupric sulfate Lanolin Cyanocobalamin (vitamin B12) Lead acetate Cystine Lidocaine Dextrose Menthol sodium Merbromin Ergocalciferol Mercuric chloride Ferric ammonium citrate Panthenol Ferric pyrophosphate Parethoxycaine hydrochloride Ferrous fumarate Phenol Ferrous gluconate Phenyltoloxamine dihydrogen citrate Ferrous sulfate (iron) Povidone-vinylacetate copolymers Flax seed Salicylic acid Folic acid Simethicone Fructose Tannic acid Guar gum Topical starch Histidine Trolamine Hydrastis canadensis Turpentine oil Inositol Zirconium oxide Iodine Zyloxin Isoleucine Juniper, potassium extract (B) Ingredients—Approved as of June 4, Karaya gum 2004; June 6, 2005, for products with an- Kelp nual sales less than $25,000. Lactose Lecithin Beeswax Leucine Bismuth subnitrate Liver concentrate Boric acid Lysine Cetyl alcohol Lysine hydrochloride Glyceryl stearate Magnesium Isopropyl palmitate Live yeast cell derivative Malt Shark liver oil Maltodextrin Stearyl alcohol Manganese citrate (19) [Reserved] Mannitol (20) Weight control drug products. Methionine Methylcellulose Alcohol Mono- and di-glycerides Alfalfa Niacinamide Alginic acid Organic vegetables Anise oil Pancreatin Arginine Pantothenic acid Ascorbic acid Papain Bearberry Papaya enzymes Biotin Pepsin Bone marrow, red Phenacetin Buchu Phenylalanine Buchu, potassium extract Phosphorus Phytolacca Caffeine citrate Pineapple enzymes Calcium Plantago seed Calcium carbonate Potassium citrate Calcium caseinate Pyridoxine hydrochloride (vitamin B6) Calcium lactate Riboflavin

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Rice polishings Benzethonium chloride Saccharin Benzoic acid Sea minerals Benzoxiquine Sesame seed Boric acid Sodium Camphor Sodium bicarbonate Candicidin Sodium caseinate Chlorothymol Sodium chloride (salt) Soybean protein Dichlorophen Soy meal Menthol Sucrose Methylparaben Thiamine hydrochloride (vitamin B1) Oxyquinoline Thiamine mononitrate (vitamin B1 mono- Oxyquinoline sulfate nitrate) Phenol Phenolate sodium Tricalcium phosphate Phenyl salicylate Tryptophan Propionic acid Tyrosine Propylparaben Uva ursi, potassium extract Resorcinol Valine Salicylic acid Vegetable Sodium borate Vitamin A Sodium caprylate Vitamin A acetate Sodium propionate Vitamin A palmitate Sulfur Vitamin E Tannic acid Wheat germ Thymol Xanthan gum Tolindate Yeast Triacetin Zinc caprylate (21) Ophthalmic drug products. (i) Oph- Zinc propionate thalmic anesthetic drug products. (iii) Any ingredient(s) labeled with Antipyrine claims or directions for use on the Piperocaine hydrochloride scalp or on the nails. (ii) Ophthalmic anti-infective drug (iv) Ingredients. products. Camphorated metacresol Boric acid Chloroxylenol Mild silver protein m-cresol Yellow mercuric oxide Nystatin (iii) Ophthalmic astringent drug prod- (23) Internal analgesic drug products— ucts. (i) Approved as of November 10, 1993. Infusion of rose petals Aminobenzoic acid Antipyrine (iv) Ophthalmic demulcent drug prod- Aspirin, aluminum ucts. Calcium salicylate 6000 Codeine phosphate (v) Ophthalmic vasoconstrictor drug Codeine sulfate products. Iodoantipyrine Lysine aspirin Phenylephrine hydrochloride (less than 0.08 Methapyrilene fumarate percent) Phenacetin maleate (22) Topical antifungal drug products. Pyrilamine maleate (i) Diaper rash drug products. Any ingre- Quinine dient(s) labeled with claims or direc- Salsalate tions for use in the treatment and/or Sodium aminobenzoate prevention of diaper rash. (ii) Approved as of February 22, 1999. (ii) Ingredients. Any atropine ingredient Alcloxa Any ephedrine ingredient Alum, potassium Aluminum sulfate (24) Orally administered menstrual drug Amyltricresols, secondary products—(i) Approved as of November 10, Basic fuchsin 1993.

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Alcohol Any atropine ingredient Alfalfa leaves Any ephedrine ingredient Aloes Asclepias tuberosa (25) Pediculicide drug products—(i) Ap- Asparagus proved as of November 10, 1993. Barosma Benzocaine Bearberry (extract of uva ursi) Benzyl alcohol Bearberry fluidextract (extract of bearberry) Benzyl benzoate Blessed thistle (cnicus benedictus) Chlorophenothane (dichlorodiphenyl tri- Buchu powdered extract (extract of buchu) ) Calcium lactate oil soap, aqueous Calcium pantothenate Copper oleate Capsicum oleoresin Docusate sodium Cascara fluidextract, aromatic (extract of Formic acid cascara) Isobornyl thiocyanoacetate Chlorprophenpyridamine maleate Cimicifuga racemosa Propylene glycol Codeine Sabadilla alkaloids Collinsonia (extract stone root) Sulfur, sublimed Corn silk Thiocyanoacetate Couch grass Dog grass extract (ii) Approved as of June 14, 1994. The Ethyl nitrite combination of pyrethrum extract (for- Ferric chloride merly named pyrethrins) and piperonyl Ferrous sulfate butoxide in an aerosol dosage formula- Gentiana lutea (gentian) tion. Glycyrrhiza (licorice) (26) Anorectal drug products—(i) Anti- Homatropine methylbromide Hydrangea, powdered extract (extract of hy- cholinergic drug products. drangea) Atropine Hydrastis canadensis (golden seal) Belladonna extract Hyoscyamine sulfate Juniper oil (oil of juniper) (ii) drug products. Boric acid Methapyrilene hydrochloride Boroglycerin Methenamine Hydrastis Methylene blue Phenol Natural estrogenic hormone Resorcinol Niacinamide Sodium salicylic acid phenolate oil (oil of nutmeg) Oil of erigeron (iii) Astringent drug products. Parsley Tannic acid Peppermint spirit Pepsin, essence (iv) Counterirritant drug products. Phenacetin Phenindamine tartrate Camphor (greater than 3 to 11 percent) Phenyl salicylate Hydrastis Menthol (1.25 to 16 percent) Piscidia erythrina Turpentine oil (rectified) (6 to 50 percent) Pipsissewa Potassium acetate (v) Keratolytic drug products. Potassium nitrate Riboflavin Precipitated sulfur Saw palmetto Sublimed sulfur Senecio aureus (vi) drug products. Sodium benzoate Sodium nitrate Diperodon Sucrose Phenacaine hydrochloride Sulferated oils of turpentine (vii) Other drug products. Taraxacum officinale Theobromine sodium salicylate Collinsonia extract Theophylline Escherichia coli vaccines Thiamine hydrochloride Lappa extract Triticum Leptandra extract Turpentine, venice (venice turpertine) Live yeast cell derivative Urea Mullein (ii) Approved as of February 22, 1999. (viii) Protectant drug products.

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Bismuth oxide Ethyl 4-[bis(hydroxypropyl)] aminobenzoate Bismuth subcarbonate Glyceryl aminobenzoate Bismuth subgallate Lawsone with dihydroxyacetone Bismuth subnitrate Red petrolatum Lanolin (30) [Reserved] (ix) Vasoconstrictor drug products. (b) Any OTC drug product that is la- Epinephrine undecylenate beled, represented, or promoted for the uses specified and containing any ac- (x) Wound healinq drug products. tive ingredient(s) as specified in para- Cholecalciferol graph (a) of this section is regarded as Cod liver oil a new drug within the meaning of sec- Live yeast cell derivative tion 210(p) of the Federal Food, Drug, Peruvian balsam and Cosmetic Act (the Act), for which Shark liver oil Vitamin A an approved new drug application under section 505 of the Act and part (xi) Combination drug products. Any 314 of this chapter is required for mar- combination drug product containing keting. In the absence of an approved hydrocortisone and pramoxine hydro- new drug application, such product is chloride. also misbranded under section 502 of (27) Topical antimicrobial drug prod- the Act. ucts—(i) First aid antiseptic drug prod- (c) Clinical investigations designed ucts. to obtain evidence that any drug prod- Ammoniated mercury uct labeled, represented, or promoted Calomel (mercurous chloride) for the OTC uses and containing any Merbromin (mercurochrome) active ingredient(s) as specified in Mercufenol chloride (ortho- paragraph (a) of this section is safe and chloromercuriphenol, ortho- effective for the purpose intended must hydroxyphenylmercuric chloride) comply with the requirements and pro- Mercuric chloride (bichloride of mercury, cedures governing the use of investiga- mercury chloride) Mercuric oxide, yellow tional new drugs set forth in part 312 of Mercuric salicylate this chapter. Mercuric sulfide, red (d) Any OTC drug product that is not Mercury in compliance with this section is sub- Mercury oleate ject to regulatory action if initially in- troduced or initially delivered for in- Nitromersol troduction into interstate commerce Para-chloromercuriphenol Phenylmercuric nitrate after the dates specified in paragraphs Thimerosal (d)(1) through (d)(39) of this section. Vitromersol (1) May 7, 1991, for products subject Zyloxin to paragraphs (a)(1) through (a)(2)(i), (ii) Diaper rash drug products. (a)(3)(i), (a)(4)(i), (a)(6)(i)(A), (a)(6)(ii)(A), (a)(7) (except as covered by Para-chloromercuriphenol paragraph (d)(3) of this section), Any other ingredient containing mercury (a)(8)(i), (a)(10)(i) through (a)(10)(iii), (28) Vaginal contraceptive drug prod- (a)(12)(i)(A), (a)(12)(ii) through ucts—(i) Approved as of October 22, 1998. (a)(12)(iv)(A), (a)(14) through (a)(15)(i), (a)(16) through (a)(18)(i)(A), (a)(18)(ii) Dodecaethylene glycol monolaurate (poly- (except as covered by paragraph (d)(22) glycol 600 monolaurate) Laureth 10S of this section), (a)(18)(iii), (a)(18)(iv), Methoxypolyoxyethyleneglycol 550 laurate (a)(18)(v)(A), and (a)(18)(vi)(A) of this Phenylmercuric acetate section. Phenylmercuric nitrate (2) February 10, 1992, for products Any other ingredient containing mercury subject to paragraph (a)(20) of this sec- (ii) Approved as of November 5, 2002. tion. Octoxynol 9 (3) December 4, 1992, for products sub- ject to paragraph (a)(7) of this section (29) Sunscreen drug products. that contain menthol as an anti- Diethanolamine methoxycinnamate pruritic in combination with the anti- Digalloyl trioleate dandruff ingredient coal tar identified

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in § 358.710(a)(1) of this chapter. This tion. April 18, 2005, for products with section does not apply to products al- annual sales less than $25,000. lowed by § 358.720(b) of this chapter (18) August 15, 1995, for products sub- after April 5, 2007. ject to paragraph (a)(15)(ii) of this sec- (4) February 28, 1990, for products tion. subject to paragraph (a)(6)(iii) of this (19) October 2, 1987, for products sub- section, except those that contain ipe- ject to paragraph (a)(6)(iv)(A) of this cac. section. (5) September 14, 1993, for products (20) January 29, 1996, for products subject to paragraph (a)(6)(iii) of this subject to paragraph (a)(6)(iv)(B) of section that contain ipecac. this section. (6) December 9, 1993, for products sub- (21) April 21, 1994, for products sub- ject to paragraph (a)(6)(i)(B) of this ject to paragraph (a)(8)(iii) of this sec- section. tion. (7) March 6, 1989, for products subject (22) April 21, 1993, for products sub- to paragraph (a)(21) of this section, ex- ject to paragraph (a)(18)(ii) of this sec- cept those that contain ophthalmic tion that contain ferric subsulfate. anti-infective ingredients listed in (23) August 23, 1995, for products sub- paragraph (a)(21)(ii). ject to paragraph (a)(6)(ii)(B) of this (8) June 18, 1993, for products subject section. to paragraph (a)(21) of this section that (24) October 7, 1996, for products sub- contain ophthalmic anti-infective in- ject to paragraph (a)(2)(ii) of this sec- gredients. tion. (9) June 18, 1993, for products subject (25) June 19, 1996, for products subject to paragraph (a)(10)(iv) of this section. to paragraph (a)(6)(iv)(C) of this sec- (10) June 18, 1993, for products subject tion. to paragraph (a)(22)(i) of this section. (26) February 22, 1999, for products (11) November 10, 1993, for products subject to paragraphs (a)(23)(ii) and subject to paragraphs (a)(8)(ii), (a)(24)(ii) of this section. (a)(10)(v) through (a)(10)(vii), (a)(18)(ii) (except products that contain ferric (27) [Reserved] subsulfate as covered by paragraph (28) October 22, 1998, for products sub- (d)(22) of this section and except prod- ject to paragraphs (a)(27) and (a)(28)(i) ucts that contain calcium acetate of this section. monohydrate as covered by paragraph (29) January 29, 1999, for products (d)(39) of this section) through subject to paragraph (a)(12)(iv)(B) of (a)(18)(v)(A), (a)(18)(vi)(A), (a)(22)(ii), this section. (a)(23)(i), (a)(24)(i), and (a)(25) of this (30) November 5, 2002, for products section. subject to paragraph (a)(12)(iv)(C) of (12) March 2, 1994, for products sub- this section. ject to paragraph (a)(22)(iii) of this sec- (31) December 31, 2002, for products tion. subject to paragraph (a)(29) of this sec- (13) August 5, 1991, for products sub- tion. ject to paragraph (a)(26) of this section, (32) June 4, 2004, for products subject except for those that contain live yeast to paragraphs (a)(18)(i)(B), (a)(18)(v)(B), cell derivative and a combination of and (a)(18)(vi)(B) of this section. June hydrocortisone and pramoxine hydro- 6, 2005, for products with annual sales chloride. less than $25,000. (14) September 2, 1994, for products (33) October 29, 2001, for products sub- subject to paragraph (a)(26)(vii) and ject to paragraph (a)(6)(iv)(D) of this (a)(26)(x) of this section that contain section. live yeast cell derivative. (34) December 9, 2004, for products (15) September 23, 1994, for products subject to paragraph (a)(4)(ii) of this subject to paragraph (a)(22)(iv) of this section. June 9, 2005, for products with section. annual sales less than $25,000. (16) June 14, 1994, for products subject (35) [Reserved] to paragraph (a)(25)(ii) of this section. (36) November 5, 2002, for products (17) April 19, 2004, for products sub- subject to paragraph (a)(28)(ii) of this ject to paragraph (a)(3)(ii) of this sec- section.

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(37) September 25, 2003, for products any drug product containing quinine or subject to paragraph (a)(26)(xi) of this quinine sulfate cannot be considered section. generally recognized as safe for the (38) October 1, 2007, for products sub- treatment and/or prevention of noc- ject to paragraph (a)(12)(i)(B) of this turnal leg muscle . section. (b) Any OTC drug product that is la- (39) September 6, 2010, for products beled, represented, or promoted for the subject to paragraph (a)(18)(ii) of this treatment and/or prevention of noc- section that contain calcium acetate turnal leg muscle cramps is regarded as monohydrate, except as provided in a new drug within the meaning of sec- § 347.20(b) of this chapter. tion 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which [55 FR 46919, Nov. 7, 1990] an approved application or abbreviated EDITORIAL NOTE: For FEDERAL REGISTER ci- application under section 505 of the act tations affecting § 310.545, see the List of CFR and part 314 of this chapter is required Sections Affected, which appears in the for marketing. In the absence of an ap- Finding Aids section of the printed volume proved new drug application or abbre- and on GPO Access. viated new drug application, such prod- EFFECTIVE DATE NOTE: At 61 FR 9571, Mar. uct is also misbranded under section 8, 1996, in § 310.545 in paragraph (a)(6)(ii)(B), 502 of the act. the entry for ‘‘l-desoxyephedrine (topical)’’ (c) Clinical investigations designed was stayed until further notice. to obtain evidence that any drug prod- § 310.546 Drug products containing ac- uct labeled, represented, or promoted tive ingredients offered over-the- for OTC use for the treatment and/or counter (OTC) for the treatment prevention of nocturnal leg muscle and/or prevention of nocturnal leg cramps is safe and effective for the pur- muscle cramps. pose intended must comply with the re- (a) Quinine sulfate alone or in com- quirements and procedures governing bination with vitamin E has been the use of investigational new drugs present in over-the-counter (OTC) drug set forth in part 312 of this chapter. products for the treatment and/or pre- (d) After February 22, 1995, any such vention of nocturnal leg muscle OTC drug product initially introduced cramps, i.e., a condition of localized or initially delivered for introduction pain in the lower extremities usually into interstate commerce that is not in occurring in middle life and beyond compliance with this section is subject with no regular pattern concerning to regulatory action. time or severity. There is a lack of ade- [59 FR 43252, Aug. 22, 1994] quate data to establish general rec- ognition of the safety and effectiveness § 310.547 Drug products containing of quinine sulfate, vitamin E, or any quinine offered over-the-counter other ingredients for OTC use in the (OTC) for the treatment and/or pre- treatment and/or prevention of noc- vention of . turnal leg muscle cramps. In the doses (a) Quinine and quinine salts have used to treat or prevent this condition, been used OTC for the treatment and/or quinine sulfate has caused adverse prevention of malaria, a serious and events such as transient visual and au- potentially life-threatening disease. ditory disturbances, dizziness, fever, Quinine is no longer the drug of choice nausea, vomiting, and . Qui- for the treatment and/or prevention of nine sulfate may cause unpredictable most types of malaria. In addition, serious and life-threatening hyper- there are serious and complicating as- sensitivity reactions requiring medical pects of the disease itself and some po- intervention and hospitalization; fa- tentially serious and life-threatening talities have been reported. The risk risks associated with the use of quinine associated with use of quinine sulfate, at doses employed for the treatment of in the absence of evidence of its effec- malaria. There is a lack of adequate tiveness, outweighs any potential ben- data to establish general recognition of efit in treating and/or preventing this the safety of quinine drug products for benign, self-limiting condition. Based OTC use in the treatment and/or pre- upon the adverse benefit-to-risk ratio, vention of malaria. Therefore, quinine

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