Code of Federal Regulations · Section
§ 333.280 — Professional Labeling
21 C.F.R. § 333.280
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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]
Authorizing Statute
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Definitions; generally21 U.S.C. § 321