Purpose
Miconazole nitrate 1200 mg (in each vaginal insert) 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 1 Combination Pack (NDC 63736-013). 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 before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Miconazole nitrate 1200 mg (in each vaginal insert) 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.
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.
vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum
external cream: 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.
1-DAY
TREATMENT
Day or Night Stays in Place
MONISTAT® 1
COMBINATION PACK
Miconazole Nitrate Vaginal Insert (1200 mg) and
Miconazole Nitrate Cream (2%) – Vaginal Antifungal
1-DAY
TREATMENT
MAXIMUM STRENGTH
1 OVULE® Insert Net Wt. 2.6 g +0.32oz (9g) Tube
* Please review the disclaimer below.