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Drug-Cosmetic Products Subject to OTC Labeling Requirements

This article was originally published in The Tan Sheet

Executive Summary

FDA decided against a broad exemption for drug-cosmetic products from the requirements of its OTC labeling final rule. The product category, which includes sunscreens, dandruff shampoos, anticaries toothpastes and antiperspirants, will be subject to the same standardized format and information order as other OTC drugs.

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Antiperspirant OTC Labeling Flexibility Requested By CTFA

Antiperspirant labeling should be allowed to drop the "Drug Facts" heading required for OTCs because it "is unnecessary and reduces the space available for important label information," the Cosmetic, Toiletry & Fragrance Association states in an April 11 citizen petition to FDA

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