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gynazole 1

Generic: butoconazole nitrate

Verified·Apr 23, 2026
Manufacturer
Sebela
NDC
45802-396
RxCUI
890785
Route
VAGINAL
ICD-10 indication
B37.3

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About gynazole 1

What is this medication?

Gynazole-1 is a prescription antifungal medication primarily used to treat vaginal yeast infections, which are medically known as vulvovaginal candidiasis. The active ingredient in this medication is butoconazole nitrate, a compound that works by interfering with the cell membranes of the fungi responsible for the infection. It is specifically formulated as a thick vaginal cream and is designed for a single-dose application, providing a convenient treatment option for individuals experiencing symptoms such as vaginal itching, burning, and abnormal discharge.

As a member of the azole class of antifungals, this medication remains in the vaginal tissues for several days after a single application to ensure the infection is thoroughly cleared. Because the cream contains mineral oil, it can weaken latex or rubber products, such as condoms and diaphragms, for up to three days following use. Patients are generally advised to complete the full treatment process and avoid other vaginal products during the recovery period to allow the medication to work effectively and restore the natural balance of the vaginal environment.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for gynazole 1. Official source: DailyMed (NLM) · Label effective Jun 1, 2023

Indications and usage
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 and 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.
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.
Warnings
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.
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.
Use in pregnancy
Pregnancy:

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How gynazole 1 appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

0%

8 of 5,509 plans

Most common tier

Tier 4

On 100% of covering formularies

Prior authorization required

0%

of covering formularies

TierFormularies on this tierShare
Tier 4 (non-preferred brand)1
100%

Step therapy: 0% of formularies

Quantity limits: 0% of formularies

Coverage breadth: 1 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

Related drugs

How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.