Draft Guidance for Industry on Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis); Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis).'' The guidance is intended to provide a general labeling format for all over-the-counter (OTC) drug products for the treatment of vaginal yeast infections. The draft guidance provides recommendations for both the carton and the educational brochure.