Molecule
Butoconazole is an azole antifungal indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida ), among other approved uses. It is available as vaginal cream. MedsAcross supplies Butoconazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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. 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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is contraindicated in patients with a history of hypersensitivity to any of the components of the product.
Source: US FDA prescribing information
This cream contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms, therefore, use of such products within 72 hours following treatment with GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is not recommended. Recurrent vaginal yeast infections, especially those that are difficult to eradicate, can be an early sign of infection with the human immunodeficiency virus (HIV) in women who are considered at risk for HIV infection.
Source: US FDA prescribing information
Of the 314 patients treated with GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% for 1 day in controlled clinical trials, 18 patients (5.7%) reported complaints such as vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. In 3 patients (1%) these complaints were considered treatment-related. Five of the 18 patients reporting adverse events discontinued the study because of them.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). Avoid heat above 30°C (86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Butoconazole, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| gynazole 1 2% vaginal creamVaginal | Padagis Israel Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 21 December 1995 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Butoconazole in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Butoconazole and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Butoconazole, including gynazole 1.
Yes. The US FDA first approved Butoconazole on 21 December 1995, according to Drugs@FDA.
No listed presentation of Butoconazole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Butoconazole is classified under ATC code G01AF15 (Butoconazole).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.