Gynazole 1

Product manufactured by Perrigo New York Inc

Application Nr Approved Date Route Status External Links
ANDA200923 None Vaginal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Gynazole • 1® Butoconazole Nitrate Vaginal Cream Usp, 2% Is Indicated For The Local Treatment Of Vulvovaginal Candidiasis (Infections Caused By Candida ). The Diagnosis Should Be Confirmed By Koh Smears And/or Cultures (See Clinical Studies ). Note: Gynazole • 1® Butoconazole Nitrate Vaginal Cream Usp, 2% Is Safe And Effective In Non-Pregnant Women; However, The Safety And Effectiveness Of This Product In Pregnant Women Has Not Been Established (See Precautions - Pregnancy ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Butoconazole Nitrate BUTOCONAZOLE NITRATE ZINC1530973

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