Butoconazole
Also sold as: Gynazole-1
Related Medications
These drugs share a pharmacologic classification but are NOT interchangeable. Listing here does not imply clinical equivalence. A physician must evaluate each drug individually for the patient's specific condition.
Classification: Azoles (source: RxClass/NLM)
- voriconazoleAzole AntifungalSame Class
- luliconazoleAzole AntifungalSame Class
- efinaconazoleAzole AntifungalSame Class
- isavuconazoleAzole AntifungalSame Class
- oteseconazoleAzole AntifungalSame Class
- clotrimazoleAzole AntifungalSame Class
- itraconazoleAzole AntifungalSame Class
- posaconazoleAzole AntifungalSame Class
- oxiconazoleAzole AntifungalSame Class
- sertaconazoleAzole AntifungalSame Class
- sulconazoleAzole AntifungalSame Class
- econazoleAzole AntifungalSame Class
- terconazoleAzole AntifungalSame Class
- tioconazoleAzole AntifungalSame Class
- fluconazoleAzole AntifungalSame Class
Insurance Coverage User-Reported
No community coverage data yet for butoconazole.
Coverage data submission coming soon.
Drug Information
Indications & Uses
INDICATIONS AND USAGE 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 (see CLINICAL STUDIES ). 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 (see PRECAUTIONS - Pregnancy ).
Dosage & Administration
DOSAGE AND ADMINISTRATION 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.
Warnings & Precautions
WARNINGS 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.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS 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.
Contraindications
CONTRAINDICATIONS 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.
Verify with Primary Sources
Always verify clinical information with authoritative sources.
Medical Disclaimer: Information on this page is sourced from FDA-approved labeling data and is for educational reference only. It does not constitute medical advice. This information does not establish a provider-patient relationship. Always verify with current prescribing information and consult a licensed healthcare professional before any clinical decision. Read full disclaimer.
Data sourced from RxNorm (NLM/NIH), FDA Orange Book, OpenFDA, DailyMed. Last updated: 2026-03-02.