eCFR Reference Browser

---

title: "21 CFR §333.310"

source: "https://www.ecfr.gov/current/title-21/section-333.310"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "333"

part_subject: "TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"

subpart_code: "D"

subpart_subject: "Topical Acne Drug Products"

section_number: "333.310"

section_subject: "Acne active ingredients."

cfr_reference: "21 CFR 333.310"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§333.310 - Acne active ingredients.