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Drug Facts
Distributed by: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Monistat 7 (NDC 63736-025). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053
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.
benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
call toll-free 877-666-4782
7 DAY TREATMENT • CREAM
MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%)
(Miconazole Nitrate 100 mg per application)
VAGINAL ANTIFUNGAL
CLINICALLY PROVEN
7 DAY TREATMENT
CURES MOST VAGINAL YEAST INFECTIONS
and relieves associated external itching and irritation
CLASSIC
Net Wt. 1.59 oz. (45g) tube
#1 DOCTOR
RECOMMENDED BRAND†
* Please review the disclaimer below.