Active Ingredient
Miconazole nitrate, USP 2% (100 mg in each applicator)
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Miconazole 7 (NDC 0363-0730). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Miconazole nitrate, USP 2% (100 mg in each applicator)
Vaginal antifungal
• treats vaginal yeast infections
• relieves external itching and irritation due to a vaginal yeast infection
For vaginal use only
if you have never had a vaginal yeast infection diagnosed by a doctor
• vaginal itching and discomfort for the first time
• lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
• vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
• been exposed to the human immunodeficiency virus (HIV) that causes AIDS
taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
• symptoms do not get better in 3 days
• symptoms last more than 7 days
• you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
• to open tube use cap to puncture seal
• do not use if seal over tube opening has been punctured or is not visible
• do not purchase if carton is open
• store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.
Well at Walgreens
WALGREENS PHARMACIST RECOMMENDED‡
NDC 0363-0730-41
Miconazole 7
Miconazole Nitrate Vaginal Cream, USP 2%
(Miconazole Nitrate 100 mg per applicator)
VAGINAL ANTIFUNGAL
7-Day Treatment
Cures most vaginal yeast infections & relieves associated external itching & irritation
Compare to Monistat®7 Vaginal Cream active ingredient‡‡
7 DAY VAGINAL CREAM (1 TUBE) WITH 7 DISPOSABLE APPLICATORS
NET WT 1.59 OZ (45 g) TUBE
* Please review the disclaimer below.