Source: https://www.law.cornell.edu/cfr/text/21/333.350
Timestamp: 2019-04-22 14:40:24+00:00

Document:
Section 333.350. Labeling of acne drug products.
21 CFR § 333.350 - Labeling of acne drug products.
§ 333.350 Labeling of acne drug products.
(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.
(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”).
(v) “Helps prevent the development of new” (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”).
(1)For products containing any ingredients identified in § 330.310.
(2)For products containing sulfur identified in § 333.310(e) and (f).
(3)For products containing any combination identified in § 333.320.
(4)For products containing benzoyl peroxide identified in § 333.310(a).
(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.
(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.

References: § 333

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