Purpose
Miconazole nitrate 4% (200 mg in each applicator) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal
The following Structured Product Label (SPL) was submitted to the FDA by Apex International Mfg., Inc. for the product Monistat 3 Combination Pack (NDC 57501-006). 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, otc - do not use, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Miconazole nitrate 4% (200 mg in each applicator) 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.
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
If you have any questions or comments, please call 1-877-666-4782
Monistat®
C O M B I N A T I O N P A C K
Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)
(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)
VAGINAL ANTIFUNGAL
• CURES most vaginal YEAST INFECTIONS
• Relieves associated external itching and irritation
3 PREFILLED APPLICATORS
plus External Cream for Itch Relief
Net Wt. 0.18 oz (5g) each applicator
+ 0.32 oz (9g) Tube
3-DAY
TREATMENT
COMBINATION PACK
Prefilled Cream
3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief
TAMPER-EVIDENT UNIT DO NOT
USE IF PRINTED APPLICATOR
WRAPPER IS TORN, OPEN OR
INCOMPLETELY SEALED.
If you have any
questions or
comments, please call
1-877-MONISTAT
(1-877-666-4782)
Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
A Prestige Consumer Healthcare company
©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
All rights reserved. MNUS013106
Monistat®
C O M B I N A T I O N P A C K
Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)
(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)
VAGINAL ANTIFUNGAL
• CURES most vaginal YEAST INFECTIONS
• Relieves associated external itching and irritation
3 PREFILLED APPLICATORS
plus External Cream for Itch Relief
Net Wt. 0.18 oz (5g) each applicator
+ 0.32 oz (9g) Tube
3-DAY
TREATMENT
COMBINATION PACK
Prefilled Cream
3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief
TAMPER-EVIDENT UNIT DO NOT
USE IF PRINTED APPLICATOR
WRAPPER IS TORN, OPEN OR
INCOMPLETELY SEALED.
If you have any
questions or
comments, please call
1-877-MONISTAT
(1-877-666-4782)
Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
A Prestige Consumer Healthcare company
©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
All rights reserved. MNUS001107
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