Monistat 3 3 Day 63736-015

Monistat 3 3 Day 63736-015
SPL v7
SPL
SPL Set ID f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5
Route
VAGINAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (40 mg)
Inactive Ingredients
Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Active Since 1998-03-30

Description

Drug Facts

Purpose

Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Description

Drug Facts

Use
  • treats vaginal yeast infections
Section 42229-5

Drug Facts

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:

    ▪ insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.

  • children under 12 years of age: ask a doctor
Questions?

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

Do Not Use If

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

Active Ingredient

Miconazole nitrate 4%

Other Information
  • do not use if printed applicator wrapper is torn, open or incompletely sealed

  • 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

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 disease (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 after 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 human immunodeficiency virus (HIV) that causes AIDS
Principal Display Panel 5 G Tube Carton

3-DAY TREATMENT

Prefilled Cream Applicator

MONISTAT ® 3

Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal

3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each

Ask A Doctor Or Pharmacist Before Use If You Are

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


Structured Label Content

Use
  • treats vaginal yeast infections
Section 42229-5 (42229-5)

Drug Facts

Purpose

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:

    ▪ insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.

  • children under 12 years of age: ask a doctor
Questions?

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

Do Not Use If (Do not use if)

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

Active Ingredient (Active ingredient)

Miconazole nitrate 4%

Other Information (Other information)
  • do not use if printed applicator wrapper is torn, open or incompletely sealed

  • 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)

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 disease (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 after 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 human immunodeficiency virus (HIV) that causes AIDS
Principal Display Panel 5 G Tube Carton (PRINCIPAL DISPLAY PANEL - 5 g Tube Carton)

3-DAY TREATMENT

Prefilled Cream Applicator

MONISTAT ® 3

Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal

3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

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


Advanced Ingredient Data


Raw Label Data

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