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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 333.280: Professional labeling.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER D—DRUGS FOR HUMAN USE
  4. PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
  5. Subpart C—Topical Antifungal Drug Products

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]

Collected 2026-08-27T02:24:47Z. Source file · JSON

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