(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:

(a) Benzoyl peroxide, 2.5 to 10 percent.

(b) Resorcinol, 2 percent, when combined with sulfur in accordance with § 333.320(a).

(c) Resorcinol monoacetate, 3 percent, when combined with sulfur in accordance with § 333.320(b).

(d) Salicylic acid, 0.5 to 2 percent.

(e) Sulfur, 3 to 10 percent.

(f) Sulfur, 3 to 8 percent, when combined with resorcinol or resorcinol monoacetate in accordance with § 333.320.

(a) Resorcinol identified in § 333.310(b) may be combined with sulfur identified in § 333.310(f).

(b) Resorcinol monoacetate identified in § 333.310(c) may be combined with sulfur identified in § 333.310(f).

(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 ingredients identified in § 330.310.

(i) The labeling states “For external use only.”

(ii) The labeling states “When using this product [bullet] skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.”

(2) For products containing sulfur identified in § 333.310(e) and (f).

(i) The labeling states “Do not use on [bullet] broken skin [bullet] large areas of the skin.”

(ii) The labeling states “When using this product [bullet] apply only to areas with acne.”

(3) For products containing any combination identified in § 333.320. (i) The labeling states “When using this product [bullet] rinse right away with water if it gets in eyes.”

(ii) The labeling states “Stop use and ask a doctor [bullet] if skin irritation occurs or gets worse.”

(4) For products containing benzoyl peroxide identified in § 333.310(a).

(i) The labeling states “Do not use if you [bullet] have very sensitive skin [bullet] are sensitive to benzoyl peroxide.”

(ii) The labeling states “When using this product [bullet] avoid unnecessary sun exposure and use a sunscreen [bullet] avoid contact with the eyes, lips, and mouth [bullet] avoid contact with hair and dyed fabrics, which may be bleached by this product [bullet] skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.”

(iii) The labeling states “Stop use and ask a doctor if [bullet] irritation becomes severe.”

(d) Directions. The labeling of the product contains the following information under the heading “Directions”:

(1) For products applied containing any ingredient identified in § 333.310. The labeling states “[bullet] clean the skin thoroughly before applying this product [bullet] cover the entire affected area with a thin layer one to three times daily [bullet] 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 [bullet] if bothersome dryness or peeling occurs, reduce application to once a day or every other day.”

(2) For products applied and left on the skin containing benzoyl peroxide identified in § 333.310(a).

(i) The labeling states the directions in paragraph (d)(1) of this section.

(ii) The labeling states “[bullet] if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.”

(3) For products applied and removed from the skin containing any ingredient identified in § 333.310. Products, such as soaps and masks, may be applied and removed and should include appropriate directions. All products containing benzoyl peroxide should include the directions in paragraph (d)(2)(ii) of this section.

(4) 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’).”