21 CFR § 333.310 Topical Antimicrobial Drug Products for Over-the-Counter Human Use

§ 333.310 Acne active ingredients.

Current through Sep 8, 2026 · Read all of Part 333

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.

[75 FR 9776, Mar. 4, 2010]

← § 333.303 Definitions.§ 333.320 Permitted combinations of active ingredients. →