Recommended Topic Related To:

Gynazole

"Investigators from the Women's Health Initiative (WHI) Hormone Trials are reaffirming conclusions that hormone therapy is not recommended for the prevention of chronic disease, but may remain a reasonable option for the short-term management "...

Gynazole

INDICATIONS

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.

HOW SUPPLIED

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.

A A A

Gynazole - User Reviews

Gynazole User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Gynazole sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.