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Important Safety Information for Gynazole•1® Butoconazole Nitrate Vaginal Cream USP, 2%

Butoconazole Nitrate Vaginal Cream USP, 2%. For the treatment of vulvovaginal candidiasis (VVC) in non-pregnant women.

Gynazole•1 Butoconazole Nitrate Vaginal Cream USP, 2% is contraindicated in patients with a history of hypersensitivity to any components of the product.

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 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.

If clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.

5.7% of patients (18/314) receiving Gynazole•1 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.

2% of patients discontinued treatment due to adverse events
1% of patients were evaluated to have treatment-related complaints

Please see full Prescribing Information

For more information about Gynazole•1, contact Customer Service at 1-866-634-9120, Monday-Friday, 8:00 am-5:00 pm (EST).

Healthcare professionals and patients with inquiries or adverse event reports, please call 1-866-634-9120.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The information on this Web site should not take the place of talking with your doctor or healthcare professional. If you have any questions about your condition, or if you would like more information about Gynazole•1, talk to your doctor or pharmacist. Only you and your healthcare professional can decide if Gynazole•1 is right for you.

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