CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 22, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR333.280]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 333 -- TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart C - Topical Antifungal Drug Products

Sec. 333.280 Professional labeling.

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]