Medicine
gynazole 1 2% vaginal cream
gynazole 1 2% vaginal cream is a prescription medicine containing Butoconazole for vaginal use, marketed by Padagis Israel Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). Avoid heat…
Key facts
- Active ingredient (INN)
- Butoconazole
- Brand
- gynazole 1
- Strength
- 2%
- Dosage form
- Vaginal cream
- Route
- Vaginal
- Packs
- 1 tube
- Marketing authorisation holder
- Padagis Israel Pharmaceuticals
- Manufacturer
- Padagis Israel Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). Avoid heat above 30°C (86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G01AF15 Butoconazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 April 2015
- Identifiers
- RxCUI 890785, 890786DailyMed set ID 125d8ede-db38-4eb9-a6be-19208687f36aNDC 45802-396Application ANDA200923
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tube, with applicator in 1 carton / 5.8 g in 1 tube, with applicator | 45802-396-01 | Padagis Israel Pharmaceuticals | 29 April 2015 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| 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 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
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
Read about ButoconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- gynazole 1 prescribing information (Padagis Israel Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need gynazole 1 2% vaginal cream for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.