Food and Drug Administration, HHS § 358.750

Pt. 358 21 CFR Ch. I (4–1–20 Edition)

up to an additional 100 milligrams 358.720 Permitted combinations of active in- daily in divided doses as required. The gredients. smallest effective dose should be used. 358.750 Labeling of drug products for the Do not exceed 300 milligrams daily. control of dandruff, seborrheic dermatitis, or psoriasis. Children under 12 years of age: consult 358.760 Labeling of permitted combinations a doctor. of active ingredients for the control of dandruff.

PART 358—MISCELLANEOUS EXTER- AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, NAL DRUG PRODUCTS FOR 360, 371.

OVER-THE-COUNTER HUMAN SOURCE: 55 FR 33255, Aug. 14, 1990, unless USE otherwise noted.

Subpart A [Reserved] Subpart A [Reserved] Subpart B—Wart Remover Drug Products Subpart B—Wart Remover Drug Sec. Products 358.101 Scope. 358.103 Definitions. § 358.101 Scope. 358.110 Wart remover active ingredients. 358.150 Labeling of wart remover drug prod- (a) An over-the-counter wart remover ucts. drug product in a form suitable for topical application is generally recognized Subpart C [Reserved] as safe and effective and is not misbranded if it meets each of the condi- Subpart D—Ingrown Toenail Relief Drug tions in this subpart and each of the Products general conditions established in § 330.1 358.301 Scope. of this chapter. 358.303 Definitions. (b) References in this subpart to reg- 358.310 Ingrown toenail relief active ingre- ulatory sections of the Code of Federal dient. Regulations are to chapter I of title 21 358.350 Labeling of ingrown toenail relief unless otherwise noted. drug products. § 358.103 Definitions. Subpart E [Reserved] As used in this subpart: Subpart F—Corn and Callus Remover Drug (a) Wart remover drug product. A top- Products ical agent used for the removal of common or plantar warts. 358.501 Scope. (b) Collodion-like vehicle. A solution 358.503 Definitions. containing pyroxylin (nitrocellulose) 358.510 Corn and callus remover active ingredients. in an appropriate nonaqueous solvent 358.550 Labeling of corn and callus remover that leaves a transparent cohesive film drug products. when applied to the skin in a thin layer. Subpart G—Pediculicide Drug Products (c) Plaster vehicle. A fabric, plastic, or other suitable backing material in 358.601 Scope. which medication is usually incor- 358.603 Definition. 358.610 Pediculicide active ingredients. porated for topical application to the 358.650 Labeling of pediculicide drug prod- skin. ucts. § 358.110 Wart remover active ingredi- Subpart H—Drug Products for the Control ents. of Dandruff, Seborrheic Dermatitis, and The product consists of any of the Psoriasis following active ingredients within the specified concentration and in the dos- 358.701 Scope. 358.703 Definitions. age form established for each ingre- 358.710 Active ingredients for the control of dient. dandruff, seborrheic dermatitis, or psori- (a) Salicylic acid 12 to 40 percent in a asis. plaster vehicle.

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(b) Salicylic acid 5 to 17 percent in a flammable,’’ ‘‘flammable,’’ ‘‘combus- collodion-like vehicle. tible,’’ consistent with 16 CFR (c) Salicylic acid 15 percent in a 1500.3(b)(10). karaya gum, glycol plaster vehicle. (ii) ‘‘Keep away from fire or flame.’’ (3) For any product formulated in a § 358.150 Labeling of wart remover volatile vehicle. ‘‘Cap bottle tightly and drug products. store at room temperature away from (a) Statement of identity. The labeling heat.’’ of the product contains the established (4) For any product formulated in a col- name of the drug, if any, and identifies lodion-like vehicle. (i) ‘‘If product gets the product as a ‘‘wart remover.’’ into the eye, flush with water for 15 (b) Indications. The labeling of the minutes.’’ product states, under the heading ‘‘In- (ii) ‘‘Avoid inhaling vapors.’’ dications,’’ any of the phrases listed in (d) Directions. The labeling of the paragraph (b) of this section. Other product contains the following infor- truthful and nonmisleading statements, describing only the indications mation under the heading ‘‘Direc- for use that have been established in tions’’: paragraph (b) of this section, may also (1) For products containing salicylic be used, as provided in § 330.1(c)(2) of acid identified in § 358.110(a). ‘‘Wash af- this chapter, subject to the provisions fected area.’’ (Optional: ‘‘May soak of section 502 of the Federal Food, wart in warm water for 5 minutes.’’) Drug, and Cosmetic Act (the act) relat- ‘‘Dry area thoroughly.’’ (If appropriate: ing to misbranding and the prohibition ‘‘Cut plaster to fit wart.’’) ‘‘Apply in section 301(d) of the act against the medicated plaster. Repeat procedure introduction or delivery for introduc- every 48 hours as needed (until wart is tion into interstate commerce of unap- removed) for up to 12 weeks.’’ proved new drugs in violation of sec- (2) For products containing salicylic tion 505(a) of the act. acid identified in § 358.110(b). ‘‘Wash af- (1) ‘‘For the removal of common fected area.’’ (Optional: ‘‘May soak warts. The common wart is easily rec- wart in warm water for 5 minutes.’’) ognized by the rough ‘cauliflower-like’ ‘‘Dry area thoroughly. Apply’’ (select appearance of the surface.’’ one of the following, as appropriate: (2) ‘‘For the removal of plantar warts ‘‘one drop’’ or ‘‘small amount’’) ‘‘at a on the bottom of the foot. The plantar time with’’ (select one of the following, wart is recognized by its location only as appropriate: ‘‘applicator’’ or on the bottom of the foot, its tender- ‘‘brush’’) ‘‘to sufficiently cover each ness, and the interruption of the foot- wart. Let dry. Repeat this procedure print pattern.’’ once or twice daily as needed (until (c) Warnings. The labeling of the wart is removed) for up to 12 weeks.’’ product contains the following warn- (3) For products containing salicylic ings under the heading ‘‘Warnings’’: acid identified in § 358.110(c). ‘‘Wash af- (1) For products containing any ingre- fected area.’’ (Optional: ‘‘May soak dient identified in § 358.110. (i) ‘‘For ex- wart in warm water for 5 minutes.’’) ternal use only.’’ ‘‘Dry area thoroughly. Gently smooth (ii) ‘‘Do not use this product on irri- wart surface with emery file supplied.’’ tated skin, on any area that is infected (If appropriate: ‘‘Cut plaster to fit or reddened, if you are a diabetic, or if wart.’’) ‘‘Apply a drop of warm water to you have poor blood circulation.’’ the wart, keeping the surrounding skin (iii) ‘‘If discomfort persists, see your dry. Apply medicated plaster at bed- doctor.’’ time and leave in place for at least 8 (iv) ‘‘Do not use on moles, birth- hours. In the morning, remove plaster marks, warts with hair growing from and discard. Repeat procedure every 24 them, genital warts, or warts on the hours as needed (until wart is removed) face or mucous membranes.’’ for up to 12 weeks.’’ (2) For any product formulated in a (e) The word ‘‘physician’’ may be sub- flammable vehicle. (i) The labeling stituted for the word ‘‘doctor’’ in any should contain an appropriate flamma- of the labeling statements in this sec- bility signal word, e.g. ‘‘extremely tion.

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(f) The phrase ‘‘or podiatrist’’ may be molecules interpenetrated with a liq- used in addition to the word ‘‘doctor’’ uid. in any of the labeling statements in this section when a product is labeled § 358.350 Labeling of ingrown toenail with the indication identified in relief drug products. § 358.150(b)(2). (a) Statement of identity. The labeling of the product contains the established [55 FR 33255, Aug. 14, 1990; 55 FR 37403, Sept. 11, 1990, as amended at 57 FR 44495, Sept. 28, name of the product, if any, and identi- 1992; 59 FR 60317, Nov. 23, 1994] fies the product as an ‘‘ingrown toenail relief product’’ or as an ‘‘ingrown toe- Subpart C [Reserved] nail discomfort reliever.’’ (b) Indications. The labeling of the product states, under the heading Subpart D—Ingrown Toenail Relief ‘‘Use,’’ the following: ‘‘for temporary Drug Products relief of’’ [select one or both of the following: ‘pain’ or ‘discomfort’] ‘‘from in- SOURCE: 68 FR 24348, May 7, 2003, unless grown toenails’’. Other truthful and otherwise noted. nonmisleading statements, describing only the use that has been established § 358.301 Scope. and listed in this paragraph (b), may (a) An over-the-counter ingrown toe- also be used, as provided in § 330.1(c)(2) nail relief drug product in a form suit- of this chapter, subject to the provi- able for topical administration is gen- sions of section 502 of the Federal erally recognized as safe and effective Food, Drug, and Cosmetic Act (the act) and is not misbranded if it meets each relating to misbranding and the prohi- condition in this subpart and each gen- bition in section 301(d) of the act eral condition established in § 330.1 of against the introduction or delivery for this chapter. introduction into interstate commerce (b) References in this subpart to reg- of unapproved new drugs in violation of ulatory sections of the Code of Federal section 505(a) of the act. Regulations are to chapter 1 of title 21 (c) Warnings. The labeling of the unless otherwise noted. product contains the following warnings under the heading ‘‘Warnings’’: § 358.303 Definitions. (1) ‘‘For external use only’’ in accord As used in this subpart: with § 201.66(c)(5)(i) of this chapter. (a) Ingrown toenail relief drug product. (2) ‘‘Do not use [bullet] 1 on open A drug product applied to an ingrown sores’’. toenail that relieves pain or discomfort (3) ‘‘Ask a doctor before use if you either by softening the nail or by hard- have [bullet] diabetes [bullet] poor cir- ening the nail bed. culation [bullet] gout’’. (b) Retainer ring. A die cut poly- (4) ‘‘When using this product [bullet] ethylene foam pad coated on one side use with a retainer ring’’. with medical grade acrylic pressure- (5) ‘‘Stop use and ask a doctor if [bul- sensitive adhesive. The retainer ring let] redness or swelling of your toe in- has slots, center-cut completely creases [bullet] discharge is present through the foam with the cut of suffi- around the nail [bullet] symptoms last cient size to allow for localization of an more than 7 days or clear up and occur active ingredient in a gel vehicle to a again within a few days’’. specific target area. The retainer ring (d) Directions. The labeling of the is used with adhesive bandage strips to product contains the following state- place over the retainer ring to hold it ments under the heading ‘‘Directions’’: in place. (1) ‘‘[Bullet] adults and children 12 years and over:’’ § 358.310 Ingrown toenail relief active (i) ‘‘[Bullet] wash the affected area ingredient. and dry thoroughly [bullet] place re- The active ingredient of the product tainer ring on toe with slot over the is sodium sulfide 1 percent in a gel vehicle. The gel vehicle is an aqueous, 1 See § 201.66(b)(4) of this chapter for defini- semisolid system with large organic tion of bullet.

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area where the ingrown nail and the § 358.510 Corn and callus remover ac- skin meet. Smooth ring down firmly. tive ingredients. [bullet] apply enough gel product to fill The product consists of any of the the slot in the ring [bullet] place round following active ingredients within the center section of bandage strip directly specified concentrations and in the dos- over the gel-filled ring to seal the gel age form established for each ingre- in place. Smooth ends of bandage strip dient. around toes.’’ (a) Salicylic acid 12 to 40 percent in a (ii) ‘‘[Bullet] repeat twice daily plaster vehicle. (morning and night) for up to 7 days (b) Salicylic acid 12 to 17.6 percent in until discomfort is relieved or until the a collodion-like vehicle. nail can be lifted out of the nail groove § 358.550 Labeling of corn and callus and easily trimmed’’. remover drug products. (2) ‘‘[Bullet] children under 12 years: (a) Statement of identity. The labeling ask a doctor’’. of the product contains the established name of the drug, if any, and identifies Subpart E [Reserved] the product as a ‘‘corn and callus remover.’’ Subpart F—Corn and Callus (b) Indications. The labeling of the Remover Drug Products product states, under the heading ‘‘In- dications,’’ the phrase listed in paragraph (b)(1) of this section and may SOURCE: 55 FR 33261, Aug. 14, 1990, unless contain the additional phrase listed in otherwise noted. paragraph (b)(2) of this section. Other truthful and nonmisleading state- § 358.501 Scope. ments, describing only the indications (a) An over-the-counter corn and cal- for use that have been established in lus remover drug product in a form paragraph (b) of this section, may also suitable for topical application is gen- be used, as provided in § 330.1(c)(2) of erally recognized as safe and effective this chapter, subject to the provisions and is not misbranded if it meets each of section 502 of the Federal Food, of the conditions in this subpart and Drug, and Cosmetic Act (the act) relat- each of the general conditions estab- ing to misbranding and the prohibition lished in § 330.1 of this chapter. in section 301(d) of the act against the (b) References in this subpart to reg- introduction or delivery for introduc- ulatory sections of the Code of Federal tion into interstate commerce of unap- Regulations are to chapter I of title 21 proved new drugs in violation of sec- unless otherwise noted. tion 505(a) of the act. (1) ‘‘For the removal of corns and cal- § 358.503 Definitions. luses.’’ (2) In addition to the information As used in this subpart: identified in paragraph (b)(1) of this (a) Corn and callus remover drug prod- section, the labeling of the product uct. A topical agent used for the re- may contain the following statement: moval of corns and calluses. ‘‘Relieves pain by removing corns and (b) Collodion-like vehicle. A solution calluses.’’ containing pyroxylin (nitrocellulose) (c) Warnings. The labeling of the in an appropriate nonaqueous solvent product contains the following warn- that leaves a transparent cohesive film ings under the heading ‘‘Warnings’’: when applied to the skin in a thin (1) For products containing any ingre- layer. dient identified in § 358.510. (i) ‘‘For ex- (c) Plaster vehicle. A fabric, plastic, or ternal use only.’’ other suitable backing material in (ii) ‘‘Do not use this product on irri- tated skin, on any area that is infected which medication is usually incor- or reddened, if you are a diabetic, or if porated for topical application to the you have poor blood circulation.’’ skin. (iii) ‘‘If discomfort persists, see your doctor or podiatrist.’’

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(2) For any product formulated in a § 358.601 Scope. flammable vehicle. (i) The labeling (a) An over-the-counter pediculicide should contain an appropriate flamma- drug product in a form suitable for top- bility signal word, e.g., ‘‘extremely ical application is generally recognized flammable,’’ ‘‘flammable,’’ ‘‘combus- as safe and effective and is not mis- tible,’’ consistent with 16 CFR branded if it meets each condition in 1500.3(b)(10). this subpart and each general condition (ii) ‘‘Keep away from fire or flame.’’ established in § 330.1 of this chapter. (3) For any product formulated in a volatile vehicle. ‘‘Cap bottle tightly and (b) References in this subpart to reg- store at room temperature away from ulatory sections of the Code of Federal heat.’’ Regulations are to chapter I of title 21 unless otherwise noted. (4) For any product formulated in a collodion-like vehicle. (i) ‘‘If product gets § 358.603 Definition. into the eye, flush with water for 15 minutes.’’ As used in this subpart: (ii) ‘‘Avoid inhaling vapors.’’ Pediculicide drug product. A drug (d) Directions. The labeling of the product for the treatment of head, product contains the following infor- pubic (crab), and body lice. mation under the heading ‘‘Direc- tions’’: § 358.610 Pediculicide active ingredi- (1) For products containing salicylic ents. acid identified in § 358.510(a). ‘‘Wash af- The active ingredients of the product fected area and dry thoroughly.’’ (If ap- consist of the combination of pyre- propriate: ‘‘Cut plaster to fit corn/cal- thrum extract (providing a concentra- lus.’’) ‘‘Apply medicated plaster. After tion of pyrethrins of 0.17 to 0.33 per- 48 hours remove the medicated plaster. cent) with piperonyl butoxide (2 to 4 Repeat this procedure every 48 hours as percent) in a nonaerosol dosage formu- needed for up to 14 days (until corn/cal- lation. lus is removed).’’ (Optional: ‘‘May soak corn/callus in warm water for 5 min- [63 FR 43303, Aug. 13, 1998] utes to assist in removal.’’) § 358.650 Labeling of pediculicide drug (2) For products containing salicylic products. acid identified in § 358.510(b). ‘‘Wash affected area and dry thoroughly. Apply’’ (a) Statement of identity. The labeling (select one of the following, as appro- of the product contains the established priate: ‘‘one drop’’ or ‘‘small amount’’) name of the drug, if any, and identifies ‘‘at a time with’’ (select one of the fol- the product as a ‘‘lice treatment.’’ lowing, as appropriate: ‘‘applicator’’ or (b) Indications. The labeling of the ‘‘brush’’) ‘‘to sufficiently cover each product states, under the heading corn/callus. Let dry. Repeat this proce- ‘‘Uses,’’ the following: ‘‘treats head, dure once or twice daily as needed for pubic (crab), and body lice.’’ Other up to 14 days (until corn/callus is re- truthful and nonmisleading state- moved).’’ (Optional: ‘‘May soak corn/ ments, describing only the uses that callus in warm water for 5 minutes to have been established and listed in this assist in removal.’’) paragraph (b), may also be used, as pro- (e) The word ‘‘physician’’ may be sub- vided in § 330.1(c)(2) of this chapter, stituted for the word ‘‘doctor’’ in any subject to the provisions of section 502 of the labeling statements in this sec- of the Federal Food, Drug, and Cos- tion. metic Act (the act) relating to misbranding and the prohibition in section [55 FR 33261, Aug. 14, 1990, as amended at 57 301(d) of the act against the introduc- FR 44494, Sept. 28, 1992] tion or delivery for introduction into interstate commerce of unapproved Subpart G—Pediculicide Drug new drugs in violation of section 505(a) Products of the act. (c) Warnings. The labeling of the SOURCE: 58 FR 65455, Dec. 14, 1993, unless product contains the following warn- otherwise noted. ings under the heading ‘‘Warnings’’:

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(1) ‘‘For external use only’’ in accord (ii) For nonshampoo products ‘‘Treat with § 201.66(c)(5)(i) of this chapter. [in bold type] [bullet] apply thoroughly (2) ‘‘Do not use [bullet] 1 near eyes to (optional, may add ‘‘dry’’) hair or [bullet] inside nose, mouth, or vagina other affected area. For head lice, first [bullet] on lice in eyebrows or eye- apply behind ears and to back of neck. lashes. See a doctor if lice are present [bullet] allow product to remain for 10 in these areas.’’ minutes, but no longer [bullet] wash (3) ‘‘Ask a doctor before use if you area thoroughly with warm water and are [bullet] allergic to ragweed. May soap or shampoo [bullet] for head lice, cause breathing difficulty or an asth- towel dry hair and comb out tangles’’. matic attack.’’ (5) ‘‘Remove lice and their eggs (nits) (4) ‘‘When using this product [bullet] [in bold type] [bullet] use a fine-tooth keep eyes tightly closed and protect or special lice/nit comb. Remove any eyes with a washcloth or towel [bullet] remaining nits by hand (using a throw- if product gets in eyes, flush with away glove). [bullet] hair should re- water right away [bullet] scalp itching main slightly damp while removing or redness may occur’’. nits [bullet] if hair dries during comb- (5) ‘‘Stop use and ask a doctor if [bul- ing, dampen slightly with water [bullet] breathing difficulty occurs [bullet] let] for head lice, part hair into sec- eye irritation occurs [bullet] skin or tions. Do one section at a time starting scalp irritation continues or infection on top of head. Longer hair may take 1 occurs’’. to 2 hours. [bullet] lift a 1- to 2-inch (d) Directions. The labeling of the wide strand of hair. Place comb as product contains the following infor- close to scalp as possible and comb mation under the heading ‘‘Direc- with a firm, even motion away from tions’’: scalp. [bullet] pin back each strand of (1) The labeling states ‘‘[bullet] Im- hair after combing [bullet] clean comb portant: Read warnings before use’’ often. Wipe nits away with tissue and [statement shall appear first and in discard in a plastic bag. Seal bag and bold type]. discard to prevent lice from coming (2) The labeling states ‘‘adults and back. [bullet] after combing, thor- children 2 years and over:’’ [in bold oughly recheck for lice/nits. Repeat type]. combing if necessary. [bullet] check (3) For head lice treatment products daily for any lice/nits that you ‘‘Inspect [in bold type] [bullet] check missed’’. each household member with a magni- (6) The labeling states ‘‘[bullet] a sec- fying glass in bright light for lice/nits ond treatment must be done in 7 to 10 (eggs) [bullet] look for tiny nits near days to kill any newly hatched lice’’. scalp, beginning at back of neck and (7) The labeling states ‘‘[bullet] if in- behind ears [bullet] examine small sec- festation continues, see a doctor for tions of hair at a time [bullet] unlike other treatments’’. dandruff which moves when touched, (8) The labeling states ‘‘children nits stick to the hair [bullet] if either under 2 years:’’ [in bold type] ‘‘ask a lice or nits are found, treat with this doctor’’. product’’. (e) Other information. The labeling of (4) Select one of the following: the product contains the following (i) For shampoo products ‘‘Treat [in statements, as appropriate, under the bold type] [bullet] apply thoroughly to heading ‘‘Other information.’’ This in- (optional, may add ‘‘dry’’) hair or other formation may appear in a package in- affected area. For head lice, first apply sert. If a package insert is used, the behind ears and to back of neck. [bul- ‘‘Other information’’ section on the let] allow product to remain for 10 min- outer carton or container label shall utes, but no longer [bullet] use warm include a statement referring to the water to form a lather, shampoo, then package insert for additional informa- thoroughly rinse [bullet] for head lice, tion. towel dry hair and comb out tangles’’. (1) ‘‘Head lice [highlighted in bold type] [bullet] lay small white eggs 1 See § 201.66(b)(4) of this chapter for defini- (nits) on hair shaft close to scalp [bul- tion of bullet symbol. let] nits are most easily found on back

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of neck or behind ears [bullet] disinfect Subpart H—Drug Products for the hats, hair ribbons, scarves, coats, tow- Control of Dandruff, els, and bed linens by machine washing Seborrheic Dermatitis, and in hot water (above 54 °C (130 °F)), then Psoriasis using hottest dryer cycle for at least 20 minutes [bullet] items that cannot be washed (bedspreads, blankets, pillows, SOURCE: 56 FR 63568, Dec. 4, 1991, unless otherwise noted. stuffed toys, etc.) should be dry- cleaned or sealed in a plastic bag for 4 § 358.701 Scope. weeks, then removed outdoors and (a) An over-the-counter dandruff, shaken out very hard before using seborrheic dermatitis, or psoriasis drug again [bullet] items that cannot be product in a form suitable for topical washed, dry-cleaned, or stored may be application is generally recognized as sprayed with a product designed for safe and effective and is not mis- this purpose [bullet] soak all combs branded if it meets each of the condi- ° and brushes in hot water (above 54 C tions in this subpart and each general (130 °F)) for at least 10 minutes [bullet] condition established in § 330.1 of this vacuum all carpets, mattresses, uphol- chapter. stered furniture, and car seats that (b) References in this subpart to reg- may have been used by affected peo- ulatory sections of the Code of Federal ple’’. Regulations are to chapter I of title 21 (2) ‘‘Pubic (crab) lice [highlighted in unless otherwise noted. bold type] [bullet] may be transmitted by sexual contact. Sexual partners § 358.703 Definitions. should be treated simultaneously to As used in this subpart: avoid reinfestation [bullet] lice are (a) Coal tar. The tar used for medic- very small and look like brown or grey inal purposes that is obtained as a by- dots on skin [bullet] usually cause in- product during the destructive distilla- tense itching and lay small white eggs tion of bituminous coal at tempera- (nits) on the hair shaft generally close tures in the range of 900 °C to 1,100 °C. to the skin surface [bullet] may be It may be further processed using ei- present on the short hairs of groin, ther extraction with alcohol and suit- thighs, trunk, and underarms, and oc- able dispersing agents and maceration casionally on the beard and mustache times or fractional distillation with or [bullet] disinfect underwear by ma- without the use of suitable organic sol- chine washing in hot water (above 54 °C vents. (130 °F)), then using hottest dryer cycle (b) Dandruff. A condition involving for at least 20 minutes’’. an increased rate of shedding of dead (3) ‘‘Body lice [highlighted in bold epidermal cells of the scalp. type] [bullet] body lice and their eggs (c) Psoriasis. A condition of the scalp (nits) are generally found in the seams or body characterized by irritation, of clothing particularly in waistline itching, redness, and extreme excess shedding of dead epidermal cells. and armpit area [bullet] body lice feed on skin then return to clothing to lay (d) Seborrheic dermatitis. A condition of the scalp or body characterized by their eggs [bullet] disinfect clothing by irritation, itching, redness, and excess machine washing in hot water (above shedding of dead epidermal cells. 54 °C (130 °F)), then using hottest dryer (e) Selenium sulfide, micronized. Se- cycle for at least 20 minutes [bullet] do lenium sulfide that has been finely not seal clothing in a plastic bag be- ground and that has a median particle cause nits can remain dormant for up size of approximately 5 micrometers to 30 days’’. (μm), with not more than 0.1 percent of [68 FR 75417, Dec. 31, 2003] the particles greater than 15 μm and not more than 0.1 percent of the particles less than 0.5 μm. [56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994]

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§ 358.710 Active ingredients for the § 358.720 Permitted combinations of control of dandruff, seborrheic der- active ingredients. matitis, or psoriasis. (a) Combination of active ingredients The active ingredient of the product for the control of dandruff. Salicylic consists of any of the following within acid identified in § 358.710(a)(4) may be the specified concentration established combined with sulfur identified in for each ingredient: § 358.710(a)(7) provided each ingredient (a) Active ingredients for the control of is present within the established con- dandruff. (1) Coal tar, 0.5 to 5 percent. centration and the product is labeled When a coal tar solution, derivative, or according to § 358.750. fraction is used as the source of the (b) Combination of control of dandruff coal tar, the labeling shall specify the and external analgesic active ingredients. identity and concentration of the coal Coal tar identified in § 358.710(a)(1) may tar source used and the concentration be used at a concentration of 1.8 per- of the coal tar present in the final cent coal tar solution, on a weight to product. volume basis, in combination with (2) Pyrithione zinc, 0.3 to 2 percent menthol, 1.5 percent, in a shampoo for- when formulated to be applied and then mulation provided the product is la- washed off after brief exposure. beled according to § 358.760. (3) Pyrithione zinc, 0.1 to 0.25 percent [72 FR 9852, Mar. 6, 2007] when formulated to be applied and left on the skin or scalp. § 358.750 Labeling of drug products for (4) Salicylic acid, 1.8 to 3 percent. the control of dandruff, seborrheic (5) Selenium sulfide, 1 percent. dermatitis, or psoriasis. (6) Selenium sulfide, micronized, 0.6 (a) Statement of identity. The labeling percent. of the product contains the established (7) Sulfur, 2 to 5 percent. name of the drug, if any, and identifies (b) Active ingredients for the control of the product with one or more of the seborrheic dermatitis. (1) Coal tar, 0.5 to following, as appropriate: 5 percent. When a coal tar solution, de- (1) ‘‘Dandruff (insert product form)’’ rivative, or fraction is used as the or ‘‘antidandruff (insert product source of the coal tar, the labeling form)’’. shall specify the identity and con- (2) ‘‘Seborrheic dermatitis (insert centration of the coal tar source used product form)’’. and the concentration of the coal tar (3) ‘‘Psoriasis (insert product form)’’. present in the final product. (b) Indications. The labeling of the (2) Pyrithione zinc, 0.95 to 2 percent product states, under the heading ‘‘In- when formulated to be applied and then dications,’’ the phrase listed in para- washed off after brief exposure. graph (b)(1) of this section and may (3) Pyrithione zinc, 0.1 to 0.25 percent contain any of the terms listed in para- when formulated to be applied and left graph (b)(2) or (b)(3) of this section. on the skin or scalp. Other truthful and nonmisleading (4) Salicylic acid, 1.8 to 3 percent. statements, describing only the indica- (5) Selenium sulfide, 1 percent. tions for use that have been established and listed in paragraph (b) of this sec- (c) Active ingredients for the control of tion, may also be used, as provided in psoriasis. (1) Coal tar, 0.5 to 5 percent. § 330.1(c)(2) of this chapter, subject to When a coal tar solution, derivative, or the provisions of section 502 of the Fed- fraction is used as the source of the eral Food, Drug, and Cosmetic Act (the coal tar, the labeling shall specify the act) relating to misbranding and the identity and concentration of the coal prohibition in section 301(d) of the act tar source used and the concentration against the introduction or delivery for of the coal tar present in the final introduction into interstate commerce product. of unapproved new drugs in violation of (2) Salicylic acid, 1.8 to 3 percent. section 505(a) of the act. [56 FR 63568, Dec. 4, 1991, as amended at 59 (1) (‘‘For relief of’’ or ‘‘Controls’’) FR 4001, Jan. 28, 1994] ‘‘the symptoms of’’ (select one or more

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of the following, as appropriate: ‘‘dan- of the body, consult your doctor before druff,’’ ‘‘seborrheic dermatitis,’’ and/or using this product.’’ ‘‘psoriasis.’’) (d) Directions. The labeling of the (2) The following terms or phrases product contains the following infor- may be used in place of or in addition mation under the heading ‘‘Direc- to the words ‘‘For the relief of’’ or tions.’’ More detailed directions appli- ‘‘Controls’’ in the indications in para- cable to a particular product formula- graph (b)(1) of this section: ‘‘fights,’’ tion may also be included. ‘‘reduces,’’ ‘‘helps eliminate,’’ ‘‘helps (1) For products containing active in- stop,’’ ‘‘controls recurrence of,’’ ‘‘fights gredients for the control of dandruff, recurrence of,’’ ‘‘helps prevent recur- seborrheic dermatitis, or psoriasis when rence of,’’ ‘‘reduces recurrence of,’’ formulated to be applied and then washed ‘‘helps eliminate recurrence of,’’ ‘‘helps off after brief (a few minutes) exposure stop recurrence of.’’ (e.g, shampoos, preshampoo rinses, (3) The following terms may be used in place of the words ‘‘the symptoms postshampoo rinses). ‘‘For best results of’’ in the indications in paragraph use at least twice a week or as directed (b)(1) of this section: (‘‘skin’’ and/or by a doctor.’’ ‘‘scalp,’’ as appropriate) (select one or (2) For products containing active in- more of the following: ‘‘itching,’’ ‘‘irri- gredients for the control of dandruff, tation,’’ ‘‘redness,’’ ‘‘flaking,’’ ‘‘scal- seborrheic dermatitis, or psoriasis when ing,’’) ‘‘associated with.’’ formulated so as to be applied and left on (c) Warnings. The labeling of the the skin or scalp (e.g., creams, ointments, product contains the following warn- lotions, hairgrooms). ‘‘Apply to affected ings under the heading ‘‘Warnings’’: areas one to four times daily or as di- (1) For products containing any ingre- rected by a doctor.’’ dient identified in § 358.710. (i) ‘‘For ex- (3) For products containing active in- ternal use only.’’ gredients for the control of seborrheic der- (ii) ‘‘Avoid contact with the eyes. If matitis or psoriasis of the skin when for- contact occurs, rinse eyes thoroughly mulated as soaps. ‘‘Use on affected areas with water.’’ in place of your regular soap.’’ (iii) ‘‘If condition worsens or does not (e) The word ‘‘physician’’ may be sub- improve after regular use of this prod- stituted for the word ‘‘doctor’’ in any uct as directed, consult a doctor.’’ of the labeling statements in this sec- (2) For any product containing coal tar tion. identified in § 358.710(a), (b), or (c). (i) ‘‘Use caution in exposing skin to sun- § 358.760 Labeling of permitted com- light after applying this product. It binations of active ingredients for may increase your tendency to sunburn the control of dandruff. for up to 24 hours after application.’’ The statement of identity, indica- (ii) ‘‘Do not use for prolonged periods tions, warnings, and directions for use, without consulting a doctor.’’ respectively, applicable to each ingre- (3) For products containing coal tar dient in the product may be combined when formulated to be applied and left on to eliminate duplicative words or the skin (e.g., creams, ointments, lotions). ‘‘Do not use this product in or around phrases so that the resulting informa- the rectum or in the genital area or tion is clear and understandable. groin except on the advice of a doctor.’’ (a) Statement of identity. For a com- (4) For products containing coal tar bination drug product that has an es- identified in § 358.710(c) for the control of tablished name, the labeling of the psoriasis. ‘‘Do not use this product with product states the established name of other forms of psoriasis therapy such the combination drug product, followed as ultraviolet radiation or prescription by the statement of identity for each drugs unless directed to do so by a doc- ingredient in the combination, as es- tor.’’ tablished in the statement of identity (5) For products containing any ingre- sections of the applicable OTC drug dient identified in § 358.710(b) or (c) for monographs. the control of seborrheic dermatitis or pso- (1) Combinations of control of dandruff riasis. ‘‘If condition covers a large area and external analgesic active ingredients

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in § 358.720(b). The label states ‘‘dan- graph (d). When the time intervals or druff/anti-itch shampoo’’ or ‘‘anti- age limitations for administration of dandruff/anti-itch shampoo’’. the individual ingredients differ, the (2) [Reserved] directions for the combination product (b) Indications. The labeling of the may not contain any dosage that ex- product states, under the heading ceeds those established for any indi- ‘‘Uses,’’ one or more of the phrases list- vidual ingredient in the applicable OTC ed in this paragraph (b), as appropriate. drug monograph(s), and may not pro- Other truthful and nonmisleading vide for use by any age group lower statements, describing only the uses than the highest minimum age limit that have been established and listed in established for any individual ingre- this paragraph (b), may also be used, as dient. provided in § 330.1(c)(2) of this chapter, (1) Combinations of control of dandruff subject to the provisions of section 502 and external analgesic active ingredients of the Federal Food, Drug, and Cos- in § 358.720(b). The labeling states metic Act (the act) relating to mis- ‘‘[bullet] wet hair [bullet] apply sham- branding and the prohibition in section poo and work into a lather [bullet] 301(d) of the act against the introduc- rinse thoroughly [bullet] for best re- tion or delivery for introduction into sults, use at least twice a week or as interstate commerce of unapproved directed by a doctor’’. new drugs in violation of section 505(a) (2) [Reserved] of the act. [72 FR 9852, Mar. 6, 2007] (1) Combinations of control of dandruff and external analgesic active ingredients PART 361—PRESCRIPTION DRUGS in § 358.720(b). The labeling states FOR HUMAN USE GENERALLY ‘‘[bullet] [select one of the following: ‘for relief of’ or ‘controls’] the symp- RECOGNIZED AS SAFE AND EF- toms of dandruff [bullet] [select one of FECTIVE AND NOT MISBRANDED: the following: ‘additional’ or ‘extra’] DRUGS USED IN RESEARCH relief of itching due to dandruff’’. (2) The following terms or phrases AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, may be used in place of or in addition 371; 42 U.S.C. 262. to the words ‘‘for the relief of’’ or ‘‘controls’’ in the indications in para- § 361.1 Radioactive drugs for certain graph (b)(1) of this section: ‘‘fights,’’ research uses. ‘‘reduces,’’ ‘‘helps eliminate,’’ ‘‘helps (a) Radioactive drugs (as defined in stop,’’ ‘‘controls recurrence of,’’ ‘‘fights § 310.3(n) of this chapter) are generally recurrence of,’’ ‘‘helps prevent recur- recognized as safe and effective when rence of,’’ ‘‘reduces recurrence of,’’ administered, under the conditions set ‘‘helps eliminate recurrence of,’’ ‘‘helps forth in paragraph (b) of this section, stop recurrence of.’’ to human research subjects during the (3) The following terms may be used course of a research project intended to in place of the words ‘‘the symptoms obtain basic information regarding the of’’ in the indication in paragraph (b)(1) metabolism (including kinetics, dis- of this section: ‘‘scalp’’ (select one or tribution, and localization) of a radio- more of the following: ‘‘itching,’’ ‘‘irri- actively labeled drug or regarding tation,’’ ‘‘redness,’’ ‘‘flaking,’’ ‘‘scal- human physiology, pathophysiology, or ing’’) ‘‘associated with’’. biochemistry, but not intended for im- (c) Warnings. The labeling of the mediate therapeutic, diagnostic, or product states, under the heading similar purposes or to determine the ‘‘Warnings,’’ the warning(s) listed in safety and effectiveness of the drug in § 358.750(c)(1) and (c)(2). humans for such purposes (i.e., to carry (d) Directions. The labeling of the out a clinical trial). Certain basic re- product states, under the heading ‘‘Di- search studies, e.g., studies to deter- rections,’’ directions that conform to mine whether a drug localizes in a par- the directions established for each in- ticular organ or fluid space and to de- gredient in the directions sections of scribe the kinetics of that localization, the applicable OTC drug monographs, may have eventual therapeutic or diag- unless otherwise stated in this para- nostic implications, but the initial

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