Active Ingredient
Miconazole nitrate, USP 2% (100 mg in each applicator)
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Miconazole 7 (NDC 0904-7734). 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
For vaginal use only
if you have never had a vaginal yeast infection diagnosed by a doctor
taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
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.
MAJOR®
NDC 0904-7734-45
MICONAZOLE 7
MICONAZOLE NITRATE VAGINAL CREAM, USP 2%
(MICONAZOLE NITRATE 100 mg PER APPLICATOR)
VAGINAL ANTIFUNGAL
CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING & IRRITATION
7 DAY VAGINAL CREAM (1 Tube) with 1 Reusable Applicator
COMPARE TO the active ingredient of MONISTAT®7 Vaginal Cream*
NET WT. 1.59 oz. (45 g) TUBE
* Please review the disclaimer below.