21 CFR § 333.310 - Acne active ingredients.
---
identifier: "/us/cfr/t21/s333.310"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 333.310 - Acne active ingredients."
title_number: 21
title_name: "Food and Drugs"
section_number: "333.310"
section_name: "Acne active ingredients."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "333"
part_name: "TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "52 FR 47322, Dec. 11, 1987, unless otherwise noted."
cfr_part: "333"
---
# 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.
[75 FR 9776, Mar. 4, 2010]