Gynazole Indications, Dosage, Storage, Stability - Butoconazole

Gynazole Indications, Dosage, Storage, Stability - Butoconazole INDICATIONS AND USES

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.

Note: GYNAZOLE·1^TM 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. )

The recommended dose of GYNAZOLE·1^TM 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^TM (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 63144