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Drug Facts
Distributed by: McNEIL-PPC, Inc., Skillman, NJ 08558
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Monistat 3 Combination Pack (NDC 63736-019). 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, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by: McNEIL-PPC, Inc., Skillman, NJ 08558
| Active ingredient | Purpose |
|---|---|
| Miconazole nitrate (200 mg in each vaginal insert) | 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 or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
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.
do not use if seal over tube opening has been punctured or embossed design is not visible
If you have any questions or comments, please call 1-877-666-4782
3 DAY TREATMENT • OVULE® INSERTS
MONISTAT® 3
Miconzole Nitrate Vaginal Inserts (200mg) and Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGAL
CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF
CURES MOST VAGINAL YEAST INFECTIONS
and relieves associated external itching and irritation
COMBINATION PACK
Net Wt. 3 OVULE® Inserts • 0.32oz (9g) tube
* Please review the disclaimer below.