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GYNAZOLE•1® (butoconazole nitrate) vaginal cream, 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) 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 (butoconazole) •1® 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, 2% is available in cartons containing one single-dose prefilled disposable applicator (NDC 64011-001-08).
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 for Ther-Rx Corporation by KV Pharmaceutical Co. St. Louis, MO 63044. 08/03. FDA Rev date: 7/24/2003
Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.
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