GroundRules
21 CFR 333.310: Acne active ingredients.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart D—Topical Acne Drug Products
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON