Active Ingredients
Miconazole nitrate, USP 200 mg (in each suppository)
Miconazole nitrate, USP 2% (external cream)
The following Structured Product Label (SPL) was submitted to the FDA by P & L Development, Llc for the product Miconazole 3 Combination Pack (NDC 59726-989). 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 ingredients, 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 200 mg (in each suppository)
Miconazole nitrate, USP 2% (external cream)
Vaginal antifungal
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 (1-800-222-1222) right away.
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to the active ingredient in Monistat® 3*
miconazole nitrate
Miconazole nitrate vaginal antifungal cream, USP 2%
and Miconazole nitrate vaginal suppositories, USP 200 mg
vaginal antifungal
combination pack
3 day treatment
net wt. oz (g) tube
+ 3 suppositories with 3 disposable applicators
*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® 3.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
* Please review the disclaimer below.