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Consumer OTC Drugs

FDA OTC vaginal antifungal products proposed class labeling announced July 16.

This article was originally published in The Tan Sheet

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Executive Summary

FDA OTC VAGINAL ANTIFUNGAL PRODUCTS PROPOSED CLASS LABELING is intended to convey a "clear and consistent message" to the consumer, FDA explains in a draft guidance announced in the July 16 Federal Register. Current labeling for OTC vaginal yeast infection products "varies widely" among manufacturers, the draft notes, adding "in the OTC setting...consumers must have information that is easily understood to allow for appropriate self-selection and appropriate use of the product."

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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