eCFR Reference Browser

---

title: "21 CFR §333.210"

source: "https://www.ecfr.gov/current/title-21/section-333.210"

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: "C"

subpart_subject: "Topical Antifungal Drug Products"

section_number: "333.210"

section_subject: "Antifungal active ingredients."

cfr_reference: "21 CFR 333.210"

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 one of the following within the specified concentration established for each ingredient:

(a)Clioquinol 3 percent.

(b)Haloprogin 1 percent.

(c)Miconazole nitrate 2 percent.

(d)Povidone-iodine 10 percent.

(e)Tolnaftate 1 percent.

(f)Undecylenic acid, calcium undecylenate, copper undecylenate, and zinc undecylenate may be used individually or in any ratio that provides a total undecylenate concentration of 10 to 25 percent.

(g)Clotrimazole 1 percent.

§333.210 - Antifungal active ingredients.