Purpose
Miconazole nitrate (200 mg in each suppository)……………….…………...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 (NDC 63736-017). 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 (200 mg in each suppository)……………….…………...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
Drug Facts (continued)
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
suppository: hydrogenated vegetable oil base
external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.
Questions? If you have any questions or comments, please call 1-877-666-4782
MONISTAT® 3
COMBINATION PACK
Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%)
VAGINAL ANTIFUNGAL
3 Vaginal Suppositories With Net Wt. 3 Suppositories +
3 Applicators plus External Cream 0.32oz (9g) tube
Principal Display Panelmonistat® 3 Combination Packmiconazole Nitrate Vaginal Suppositories (200 mg) And Miconazole Nitrate Vaginal Cream (2%) Vaginal Antifungal3 Vaginal Suppositories With Net Wt. 3 Suppositories +3 Applicators Plus External Cream 0.32oz (9g) Tube (Monistat 3 Cure Itch Relief Suppository Cream 01)
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