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Drug Facts
Distributed by: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals for the product Monistat 1 Combination Pack (NDC 63736-014). 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: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053
| Active ingredients | Purpose |
|---|---|
| Miconazole nitrate 1200 mg (in 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.
call toll-free 877-666-4782
1 DAY TREATMENT • OVULE® INSERT
MONISTAT® 1
Miconazole Nitrate Vaginal Insert (1200mg) 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
# 1 DOCTOR
RECOMMENDED BRAND†
Net Wt. 1 OVULE® Insert • 0.32oz (9g) tube
* Please review the disclaimer below.