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

Description

DRUG FACTS

Purpose

Vaginal antifungal Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Vaginal antifungal

Description

DRUG FACTS

Uses
  • treats vaginal yeast infections

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

  • 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
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
Questions?

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

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.
Active Ingredients

Miconazole nitrate 4%

Miconazole nitrate 2% (external cream)

Inactive Ingredients

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

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 

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

Uses
  • treats vaginal yeast infections

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

DRUG FACTS

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:

  • 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
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
Questions?

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

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.
Active Ingredients (Active ingredients)

Miconazole nitrate 4%

Miconazole nitrate 2% (external cream)

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 

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

All Sections (JSON)