Purpose
Miconazole nitrate 4% (200 mg in each applicator) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Monistat 3 Combination Pack (NDC 63736-010). 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 purpose, uses, warnings, do not use, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Miconazole nitrate 4% (200 mg in each applicator) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal
For vaginal use only
if you have never had a vaginal yeast infection diagnosed by a doctor.
Ask a doctor before use if you have
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, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
If you have any questions or comments, please call 1-877-666-4782
- Kit Carton
MONISTAT® 3
COMBINATION PACK
Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)
(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)
VAGINAL ANTIFUNGAL
3 PREFILLED APPLICATORS Net Wt. 0.18 oz. (5g) each applicator
plus External Cream for Itch Relief +0.32 oz. (9g) tube
* Please review the disclaimer below.