Monistat 1 Combination Pack
Monistat 1 COMBINATION PACK_Suppository-tube_63736-013-30
97ff1c90-c250-4921-81af-6a56cc9cc7d2
HUMAN OTC DRUG LABEL
Aug 22, 2025
Insight Pharmaceuticals LLC
DUNS: 055665422
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Miconazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
1-DAY****
TREATMENT
NEW LOOK!****
MONISTAT®** 1**
COMBINATION PACK
Miconazole Nitrate Vaginal Insert (1200 mg) and
Miconazole Nitrate Cream (2%) – Vaginal Antifungal
1-DAY
TREATMENT
MAXIMUM STRENGTH
1 OVULE® Insert Net Wt. 2.6 g +0.32oz (9g) Tube

INDICATIONS & USAGE SECTION
Uses
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treats vaginal yeast infections
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relieves external itching and irritation due to a vaginal yeast infection
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
OTC - PURPOSE SECTION
Purpose
Miconazole nitrate 1200 mg (in vaginal insert) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal
WARNINGS SECTION
Warnings
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
*vaginal itching and discomfort for the first time
*lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
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vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
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been exposed to the human immunodeficiency virus (HIV) that causes AIDS
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
-
do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
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do not have vaginal intercourse
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mild increase in vaginal burning, itching or irritation may occur
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if you do not get complete relief ask a doctor before using another product
Stop use and ask a doctor if
*symptoms do not get better in 3 days
*symptoms last more than 7 days
*you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
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.
DOSAGE & ADMINISTRATION SECTION
Directions
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before using this product read the enclosed consumer information leaflet for complete directions and information
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adults and children 12 years of age and over: *vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away.
*external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
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children under 12 years of age: ask a****doctor
OTHER SAFETY INFORMATION
Other information
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do not use ifprinted sealed pouch is torn, open or incompletely sealed
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do not use if seal over tube opening has been punctured
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do not purchase if carton is open
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store at 20°-25°C (68°-77°F)
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this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.
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Keep this carton for future reference. It contains important information.
INACTIVE INGREDIENT SECTION
Inactive ingredients
vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum
external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
OTC - QUESTIONS SECTION
Questions?
If you have any questions or comments, please call 1-877-666-4782.