MedPath

Monistat 1 Combination Pack

Monistat 1 COMBINATION PACK_Suppository-tube_63736-013-30

Approved
Approval ID

97ff1c90-c250-4921-81af-6a56cc9cc7d2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 22, 2025

Manufacturers
FDA

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
NDC Product Code63736-013
Application NumberNDA021308
Product Classification
M
Marketing Category
C73594
G
Generic Name
Miconazole Nitrate
Product Specifications
Effective DateAugust 22, 2025
FDA Product Classification

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/22/2025

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

![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 ](/dailymed/image.cfm?name=monistat-1-combination-pack_suppository- tube_63736-01.jpg&id=894048)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/22/2025

Uses

  • treats vaginal yeast infections

  • relieves external itching and irritation due to a vaginal yeast infection

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/22/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/22/2025

Active ingredients

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/22/2025

Purpose

Miconazole nitrate 1200 mg (in vaginal insert) Vaginal antifungal

Miconazole nitrate 2% (external cream) Vaginal antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 8/22/2025

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.

  • 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.

  • 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).

  • do not have vaginal intercourse

  • mild increase in vaginal burning, itching or irritation may occur

  • 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

LOINC: 34068-7Updated: 8/22/2025

Directions

  • before using this product read the enclosed consumer information leaflet for complete directions and information

  • 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.

  • children under 12 years of age: ask a****doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/22/2025

Other information

  • do not use ifprinted sealed pouch is torn, open or incompletely sealed

  • do not use if seal over tube opening has been punctured

  • do not purchase if carton is open

  • store at 20°-25°C (68°-77°F)

  • 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.

  • Keep this carton for future reference. It contains important information.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/22/2025

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

LOINC: 53413-1Updated: 8/22/2025

Questions?

If you have any questions or comments, please call 1-877-666-4782.

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