Other
Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream
(2%)
Vaginal Antifungal
DRUG FACTS
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals for the product Monistat 3 Combination Pack (NDC 63736-018). 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, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream
(2%)
Vaginal Antifungal
DRUG FACTS
| Active ingredients | Purpose |
|---|---|
| Miconazole nitrate (200 mg in each suppository) | Vaginal antifungal |
| Miconazole nitrate 2% (external cream) | 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.
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
Visit our website @ www.monistat.com
PRINCIPAL DISPLAY PANEL - Kit Carton
3 DAY TREATMENT • CREAM
MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)
(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)
VAGINAL ANTIFUNGAL
CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF
CURES MOST VAGINAL YEAST INFECTIONS
and relieves associated external itching and irritation
COMBINATION PACK
Net Wt. 0.18 oz. (5g) each applicator • 0.32 oz. (9g) tube
* Please review the disclaimer below.