Active Ingredient
Miconazole nitrate 2% (100 mg in each applicatorful)
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Monistat 7 (NDC 63736-026). 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, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Miconazole nitrate 2% (100 mg in each applicatorful)
Vaginal antifungal
For vaginal use only
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
do not use if seal over tube opening has been punctured
call toll-free 877-666-4782
Distributed by: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053
7 DAY TREATMENT • CREAM
MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%)
(Miconazole Nitrate 100 mg per application)
VAGINAL ANTIFUNGAL
CURES MOST VAGINAL YEAST INFECTIONS
and relieves associated external itching and irritation
CLINICALLY PROVEN
7 DAY TREATMENT
CLASSIC
#1 DOCTOR
RECOMMENDED BRAND†
Net Wt. 1.59 oz. (45g) tube
* Please review the disclaimer below.