monistat 7 cure itch relief - reuseableapps-cream

monistat 7 cure itch relief - reuseableapps-cream
SPL v5
SPL
SPL Set ID 2aad40f2-4eea-441d-8b34-5613f1955405
Route
vaginal
Published
Effective Date 2025-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (20 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 1993-04-26

Purpose

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

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:

    applicator: Insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.

    ○ use the same tube of cream if you have itching and irritation on the skin outside the vagina. 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.
Inactive Ingredients

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

Description

Drug Facts

Questions?

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

P

MONISTAT® 7

Miconazole Nitrate Vaginal Cream (2%)

Vaginal Antifungal

1 Reusable Applicator

Net Wt. 1.59 oz. (45g) Tube

Section 42229-5

Drug Facts

Other I
  • 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.
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

Active Ingredients

Miconazole nitrate 2%

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, committing, 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

Warnings

For vaginal use only

Uses
  • treats vaginal yeast infections

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

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:

    applicator: Insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.

    ○ use the same tube of cream if you have itching and irritation on the skin outside the vagina. 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.
Inactive Ingredients (Inactive ingredients)

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

Questions?

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

P

MONISTAT® 7

Miconazole Nitrate Vaginal Cream (2%)

Vaginal Antifungal

1 Reusable Applicator

Net Wt. 1.59 oz. (45g) Tube

Section 42229-5 (42229-5)

Drug Facts

Other I (Other i)
  • 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.
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

Active Ingredients (Active ingredients)

Miconazole nitrate 2%

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, committing, 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

All Sections (JSON)