21 C.F.R. Subpart D—Topical Acne Drug Products
Title 21 - Food and Drugs
Source: 56 FR 41019, Aug. 16, 1991, unless otherwise noted.
(a) An over-the-counter acne drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in §330.1 of this chapter. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. As used in this subpart: (a) Acne. A disease involving the oil glands and hair follicles of the skin which is manifested by blackheads, whiteheads, acne pimples, and acne blemishes. (b) Acne blemish. A flaw in the skin resulting from acne. (c) Acne drug product. A drug product used to reduce the number of acne blemishes, acne pimples, blackheads, and whiteheads. (d) Acne pimple. A small, prominent, inflamed elevation of the skin resulting from acne. (e) Blackhead. A condition of the skin that occurs in acne and is characterized by a black tip. (f) Whitehead. A condition of the skin that occurs in acne and is characterized by a small, firm, whitish elevation of the skin. The active ingredient of the product consists of any of the following when labeled according to §333.350. (a) Resorcinol 2 percent when combined in accordance with §333.320(a). (b) Resorcinol monoacetate 3 percent when combined in accordance with §333.320(b). (c) Salicylic acid 0.5 to 2 percent. (d) Sulfur 3 to 10 percent. (e) Sulfur 3 to 8 percent when combined in accordance with §333.320. (a) Resorcinol identified in §333.310(a) when combined with sulfur identified in §333.310(e) provided the product is labeled according to §333.350. (b) Resorcinol monoacetate identified in §333.310(b) when combined with sulfur identified in §333.310(e) provided the product is labeled according to §333.350. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “acne medication,” “acne treatment,” “acne medication” (insert dosage form, e.g., “cream,” “gel,” “lotion,” or “ointment”), or “acne treatment” (insert dosage form, e.g., “cream,” “gel,” “lotion,” or “ointment”). (b) Indications. The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1) of this section and may contain any of the additional phrases listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in §330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (1) “For the” (select one of the following: “management” or “treatment”) “of acne.” (2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain any one or more of the following statements: (i) (Select one of the following: “Clears,” “Clears up,” “Clears up most,” “Dries,” “Dries up,” “Dries and clears,” “Helps clear,” “Helps clear up,” “Reduces the number of,” or “Reduces the severity of”) (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”) which may be followed by “and allows skin to heal.” (ii) “Penetrates pores to” (select one of the following: “eliminate most,” “control,” “clear most,” or “reduce the number of”) (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”). (iii) “Helps keep skin clear of new” (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”). (iv) “Helps prevent new” (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”) which may be followed by “from forming.” (v) “Helps prevent the development of new” (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”). (c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”: (1) For products containing any ingredient identified in §333.310. (i) “For external use only.” (ii) “Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.” (2) For products containing sulfur identified in §§333.310 (d) and (e). “Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.” (3) For products containing any combination identified in §333.320. “Apply to affected areas only. Do not use on broken skin or apply to large areas of the body.” (d) Directions. The labeling of the product contains the following information under the heading “Directions”: (1) “Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.” (2) The directions described in paragraph (d)(1) of this section are intended for products that are applied and left on the skin. Other products, such as soaps or masks, may be applied and removed and should have appropriate directions. (3) Optional directions. In addition to the required directions in paragraphs (d)(1) and (d)(2) of this section, the product may contain the following optional labeling: “Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated: (select one of the following: ‘elsewhere on this label,’ ‘above,’ or ‘below.’)” (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.
Title 21: Food and Drugs
PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart D—Topical Acne Drug Products
§ 333.301 Scope.
§ 333.303 Definitions.
§ 333.310 Acne active ingredients.
§ 333.320 Permitted combinations of active ingredients.
§ 333.350 Labeling of acne drug products.
