Monistat 7 Cure Itch Relief - Prefilledapps-cream

Monistat 7 Cure Itch Relief - Prefilledapps-cream
SPL v6
SPL
SPL Set ID 9b1ac735-9b18-48c2-86dc-93d07157d5e5
Route
VAGINAL
Published
Effective Date 2025-08-22
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

Description

MONISTAT 7 COMBINATION PACK  7-DAY PRE-FILLED APPLICATORS- miconazole nitrate   Insight Pharmaceuticals ---------- MONISTAT ®  7 Combination Pack Drug Facts

Purpose

Vaginal antifungal Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Vaginal antifungal

Description

MONISTAT 7 COMBINATION PACK  7-DAY PRE-FILLED APPLICATORS- miconazole nitrate   Insight Pharmaceuticals ---------- MONISTAT ®  7 Combination Pack Drug Facts

Uses
  • treats vaginal yeast infections

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

MONISTAT 7 COMBINATION PACK  7-DAY PRE-FILLED APPLICATORS- miconazole nitrate  

Insight Pharmaceuticals

----------

MONISTAT ®  7 Combination Pack

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 7 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 .

Questions?

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

Active Ingredient

Miconazole nitrate 2%

Miconazole nitrate 2% (external cream)

Other Information
  • do not use if not use if seal over tube opening has been punctured

  • do not purchase if carton is open

  • store at 20° - 25°C (68° to 77°F)

  • Keep this carton for future refeence. 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
Ask A Doctor Or Pharmacist

before use if you are

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

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 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 Kit Carton

7- DAY

TREATMENT




NEW LOOK! 

MONISTAT ®  7 

Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal

COMBINATION PACK

7- DAY

TREATMENT


____________

CREAM

Cream with 7 Disposable Applicators plus External Cream for Itch Relief    

Net Wt. 1.59 oz (45 g) Tube + 0.32 oz (9 g) Tube

+ 7 Disposable Applicators


Structured Label Content

Uses
  • treats vaginal yeast infections

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

MONISTAT 7 COMBINATION PACK  7-DAY PRE-FILLED APPLICATORS- miconazole nitrate  

Insight Pharmaceuticals

----------

MONISTAT ®  7 Combination Pack

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 7 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 .

Questions?

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

Active Ingredient (Active ingredient)

Miconazole nitrate 2%

Miconazole nitrate 2% (external cream)

Other Information (Other information)
  • do not use if not use if seal over tube opening has been punctured

  • do not purchase if carton is open

  • store at 20° - 25°C (68° to 77°F)

  • Keep this carton for future refeence. 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
Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

before use if you are

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

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 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 Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

7- DAY

TREATMENT




NEW LOOK! 

MONISTAT ®  7 

Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal

COMBINATION PACK

7- DAY

TREATMENT


____________

CREAM

Cream with 7 Disposable Applicators plus External Cream for Itch Relief    

Net Wt. 1.59 oz (45 g) Tube + 0.32 oz (9 g) Tube

+ 7 Disposable Applicators


Advanced Ingredient Data


Raw Label Data

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