monistat 3 combination pack - 63736-010

monistat 3 combination pack - 63736-010
SPL v9
SPL
SPL Set ID e1b8ad40-5adb-482a-b532-3f8e30d90128
Route
vaginal
Published
Effective Date 2025-10-27
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

Pill Appearance
Color: white
Marketing Status
nda active Since 2009-12-10

Purpose

Vaginal antifungal Vaginal antifungal

Description

DRUG FACTS


Medication Information

Warnings

For vaginal use only

Uses
  • treats vaginal yeast infections

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

Vaginal antifungal

Vaginal antifungal

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:

  • applicators : insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw away applicator 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
Other Information
  • do not use if printed applicator wrapper 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)

  • 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

Description

DRUG FACTS

Principal Display Panel

- Kit Carton

MONISTAT ® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%) - Vaginal Antifungal

3 PREFILLED APPLICATORS             Net Wt. 0.18 oz. (5g) +0.32 oz. (9g) tube 

Questions?

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

Section 42229-5

DRUG FACTS

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
Active Ingredients

Miconazole nitrate 4%

Miconazole nitrate 2% (external cream)

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 Or Pharmacist Before Use If You Are

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


Structured Label Content

Warnings

For vaginal use only

Uses
  • treats vaginal yeast infections

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

Vaginal antifungal

Vaginal antifungal

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:

  • applicators : insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw away applicator 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
Other Information (Other information)
  • do not use if printed applicator wrapper 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)

  • 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

- Kit Carton

MONISTAT ® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%) - Vaginal Antifungal

3 PREFILLED APPLICATORS             Net Wt. 0.18 oz. (5g) +0.32 oz. (9g) tube 

Questions?

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

Section 42229-5 (42229-5)

DRUG FACTS

Do Not Use (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
Active Ingredients (Active ingredients)

Miconazole nitrate 4%

Miconazole nitrate 2% (external cream)

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 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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