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Vaginal yeast infection product labeling

This article was originally published in The Tan Sheet

Executive Summary

Perrigo suggests OTC private label vaginal yeast infection treatments be allowed to make the labeling statement "If you have questions of a medical nature, ask your doctor, pharmacist or health care provider" as an alternative to a toll-free number statement. The private label manufacturer makes the recommendation in Oct. 13 comments on FDA's proposed labeling guidance for OTC vaginal yeast infection treatments issued July 16 ("The Tan Sheet" July 20, p. 5). Perrigo urges FDA "note in the guidance that the listing of the toll-free number is not intended to suggest that such listing is a prerequisite for marketing an OTC vaginal antifungal drug product," adding, many vaginal yeast infection treatments "are available as store brands and do not contain toll-free listings." Also, Perrigo urges the implementation date for the guidance be the same as OTC labeling reform to allow companies to combine labeling changes
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