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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).
DOSAGE AND ADMINISTRATION
The recommended dose of GYNAZOLE•1® Butoconazole Nitrate Vaginal Cream USP, 2% is one applicatorful of cream (approximately 5 grams of the cream) intravaginally. This amount of cream contains approximately 100 mg of butoconazole nitrate.
GYNAZOLE•1® Butoconazole Nitrate Vaginal Cream USP, 2% is available in cartons containing one single-dose prefilled disposable applicator (NDC 45802-396-01).
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature], Avoid heat above 30°C (86°F).
Manufactured By Perrigo, Yeruham 80500, Israel. Revised: Nov 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/12/2016
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