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Food and Drug Administration, HHS § 333.350

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Food and Drug Administration, HHS § 333.350 Food and Drug Administration, HHS § 333.350 (b) References in this subpart to reg- § 333.350 Labeling of acne drug prod- ulatory sections of the Code of Federal ucts. Regulations are to chapter I of title 21 (a) Statement of identity. The labeling unless otherwise noted. of the product contains the established name of the drug, if any, and identifies § 333.303 Definitions. the product as an ‘‘acne medication,’’ As used in this subpart: ‘‘acne treatment,’’ ‘‘acne medication’’ (a) Acne. A disease involving the oil (insert dosage form, e.g., ‘‘cream,’’ glands and hair follicles of the skin ‘‘gel,’’ ‘‘lotion,’’ or ‘‘ointment’’), or which is manifested by blackheads, ‘‘acne treatment’’ (insert dosage form, whiteheads, acne pimples, and acne e.g., ‘‘cream,’’ ‘‘gel,’’ ‘‘lotion,’’ or blemishes. ‘‘ointment’’). (b) Acne blemish. A flaw in the skin (b) Indications. The labeling of the resulting from acne. product states, under the heading ‘‘In- (c) Acne drug product. A drug product dications,’’ the phrase listed in para- used to reduce the number of acne graph (b)(1) of this section and may blemishes, acne pimples, blackheads, contain any of the additional phrases and whiteheads. listed in paragraph (b)(2) of this sec- (d) Acne pimple. A small, prominent, tion. Other truthful and nonmisleading inflamed elevation of the skin result- statements, describing only the indica- ing from acne. tions for use that have been established (e) Blackhead. A condition of the skin and listed in paragraph (b) of this sec- that occurs in acne and is character- tion, may also be used, as provided in ized by a black tip. § 330.1(c)(2) of this chapter, subject to (f) Whitehead. A condition of the skin the provisions of section 502 of the Fed- that occurs in acne and is character- eral Food, Drug, and Cosmetic Act (the ized by a small, firm, whitish elevation act) relating to misbranding and the of the skin. prohibition in section 301(d) of the act against the introduction or delivery for § 333.310 Acne active ingredients. introduction into interstate commerce of unapproved new drugs in violation of The active ingredient of the product section 505(a) of the act. consists of any of the following: (1) ‘‘For the’’ (select one of the fol- (a) Benzoyl peroxide, 2.5 to 10 per- lowing: ‘‘management’’ or ‘‘treat- cent. ment’’) ‘‘of acne.’’ (b) Resorcinol, 2 percent, when com- (2) In addition to the information bined with sulfur in accordance with identified in paragraph (b)(1) of this § 333.320(a). section, the labeling of the product (c) Resorcinol monoacetate, 3 per- may contain any one or more of the cent, when combined with sulfur in ac- following statements: cordance with § 333.320(b). (i) (Select one of the following: (d) Salicylic acid, 0.5 to 2 percent. ‘‘Clears,’’ ‘‘Clears up,’’ ‘‘Clears up (e) Sulfur, 3 to 10 percent. most,’’ ‘‘Dries,’’ ‘‘Dries up,’’ ‘‘Dries and (f) Sulfur, 3 to 8 percent, when com- clears,’’ ‘‘Helps clear,’’ ‘‘Helps clear bined with resorcinol or resorcinol up,’’ ‘‘Reduces the number of,’’ or ‘‘Re- monoacetate in accordance with duces the severity of’’) (select one or § 333.320. more of the following: ‘‘acne blem- [75 FR 9776, Mar. 4, 2010] ishes,’’ ‘‘acne pimples,’’ ‘‘blackheads,’’ or ‘‘whiteheads’’) which may be fol- § 333.320 Permitted combinations of lowed by ‘‘and allows skin to heal.’’ active ingredients. (ii) ‘‘Penetrates pores to’’ (select one of the following: ‘‘eliminate most,’’ (a) Resorcinol identified in § 333.310(b) ‘‘control,’’ ‘‘clear most,’’ or ‘‘reduce may be combined with sulfur identified the number of’’) (select one or more of in § 333.310(f). the following: ‘‘acne blemishes,’’ ‘‘acne (b) Resorcinol monoacetate identified pimples,’’ ‘‘blackheads,’’ or in § 333.310(c) may be combined with ‘‘whiteheads’’). sulfur identified in § 333.310(f). (iii) ‘‘Helps keep skin clear of new’’ [75 FR 9776, Mar. 4, 2010] (select one or more of the following: 235 VerDate Mar<15>2010 14:51 May 15, 2012 Jkt 226071 PO 00000 Frm 00245 Fmt 8010 Sfmt 8010 Y:\SGML\226071.XXX 226071 emcdonald on DSK7TPTVN1PROD with CFR.
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