Monistat 3 Combination Pack_ovule Inserts-tube_63736-019-03

Monistat 3 Combination Pack_ovule Inserts-tube_63736-019-03
SPL v4
SPL
SPL Set ID 910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd
Route
VAGINAL
Published
Effective Date 2025-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (200 mg)
Inactive Ingredients
Gelatin Glycerin Titanium Dioxide Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol

Identifiers & Packaging

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

A

Miconazole nitrate (200 mg in each vaginal insert)

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

Other I
  • do not use if printed sealed pouches containing vaginal inserts 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

vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

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

Warnings

For vaginal use only

Questions

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

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 a disposable applicator, place the insert 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

Ask A Doctor Or P

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

Keep Out of Reach Of

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

Principal Display Panel

MONISTAT ® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Inserts (200 mg) and

Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal

3 OVULE® Inserts Net Wt. 2.5 g each

  + 0.32 oz (9 g) Tube

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
If Pregnant Or Breast Feeding

ask a health professional before use.

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, v omiting, or foul-smelling vaginal discharge                                            
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

A

Miconazole nitrate (200 mg in each vaginal insert)

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

Other I (Other i)
  • do not use if printed sealed pouches containing vaginal inserts 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.
Purpose

Vaginal antifungal

Vaginal antifungal

Inactive

vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

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

Warnings

For vaginal use only

Questions

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

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 a disposable applicator, place the insert 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

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

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

Keep Out of Reach Of (Keep out of reach of)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MONISTAT ® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Inserts (200 mg) and

Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal

3 OVULE® Inserts Net Wt. 2.5 g each

  + 0.32 oz (9 g) Tube

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
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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, v omiting, or foul-smelling vaginal discharge                                            
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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