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Cosmetic-drug dosage limitation exemption in OTC labeling proposed by CTFA.

This article was originally published in The Rose Sheet

Executive Summary

COSMETIC-DRUG "FREQUENCY OF DOSAGE" OTC LABELING EXEMPTION URGED BY CTFA in Oct. 6 comments to FDA on the agency's proposed regulations for over-the-counter drug labeling as published in the Feb. 27 Federal Register. The Cosmetic, Toiletry and Fragrance Association maintains that FDA's proposed OTC labeling revisions "are not relevant" to cosmetic-drugs that do not have limitations on the frequency, size or number of doses. CTFA's proposed amendment would deem a product exempt if it were defined as a cosmetic-drug and had no dosage limitation. Products that would fall under that definition include sunscreens, dandruff shampoos and antiperspirants.
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