Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE
/ PART 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
/ Subpart D - Topical Acne Drug Products / § 333.310 Acne active ingredients.
§ 333.310 Acne active ingredients.
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.