eCFR Reference Browser

---

title: "21 CFR §333.280"

source: "https://www.ecfr.gov/current/title-21/section-333.280"

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: "333.280"

section_subject: "Professional labeling."

cfr_reference: "21 CFR 333.280"

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 labeling provided to health professionals (but not to the general public) may contain the following additional indication:

(a)For products containing haloprogin or miconazole nitrate identified in § 333.210 (a) and (c). “For the treatment of superficial skin infections caused by yeast (Candida albicans).”

(b)[Reserved]

§333.280 - Professional labeling.