CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART D—Topical Acne Drug Products (§333.301 to §333.350) > 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.

Code of Federal Regulations

[75 FR 9776, Mar. 4, 2010]