Monistat 3 Cure Itch Relief_suppository-cream

Monistat 3 Cure Itch Relief_suppository-cream
SPL v3
SPL
SPL Set ID 674f2e66-e7e3-40ff-aa21-adaf5d55dcda
Route
VAGINAL
Published
Effective Date 2025-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (200 mg)
Inactive Ingredients
Hydrogenated Palm Kernel Oil Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: white
Marketing Status
NDA Active Since 1996-04-16

Description

Drug Fa c ts

Purpose

Vaginal antifungal Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Vaginal antifungal

Description

Drug Fa c ts

P

MONISTAT® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%) 

VAGINAL ANTIFUNGAL

3 Suppositories Net Wt. 2.5 g each _ 0.32 oz (9 g) Tube

Act

Miconazole nitrate (200 mg in each suppository)

Miconazole nitrate 2% (external cream)

Uses
  • treats vaginal yeast infections

  • relieves external itching and irritation due to a vaginal yeast infection
Section 42229-5

Drug Fa c ts

Warnings

For vaginal use only

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:

    suppositories: insert 1 suppository into the vagina at bedtime for three nights in a row. Throw applicator away after use.

    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.
Do Not Use

if you have never had a vaginal yeast infection diagnosed by a doctor

Questions?

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

Ask A Doctor Or P

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

Other Information
  • do not use if printed suppository blisters are 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)

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

suppository: hydrogenated vegetable oil base

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.

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.

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

Structured Label Content

P

MONISTAT® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%) 

VAGINAL ANTIFUNGAL

3 Suppositories Net Wt. 2.5 g each _ 0.32 oz (9 g) Tube

Act

Miconazole nitrate (200 mg in each suppository)

Miconazole nitrate 2% (external cream)

Uses
  • treats vaginal yeast infections

  • relieves external itching and irritation due to a vaginal yeast infection
Section 42229-5 (42229-5)

Drug Fa c ts

Purpose

Vaginal antifungal

Vaginal antifungal

Warnings

For vaginal use only

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:

    suppositories: insert 1 suppository into the vagina at bedtime for three nights in a row. Throw applicator away after use.

    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.
Do Not Use (Do not use)

if you have never had a vaginal yeast infection diagnosed by a doctor

Questions?

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

Ask A Doctor Or P (Ask a doctor or p)

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

Other Information
  • do not use if printed suppository blisters are 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)

  • Keep this carton for future reference. It contains important information.
Inactive Ingredients (Inactive ingredients)

suppository: hydrogenated vegetable oil base

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.

When Using This Product (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: (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

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