Monistat 7 Simply - 7 Dispos Apps-cream

Monistat 7 Simply - 7 Dispos Apps-cream
SPL v6
SPL
SPL Set ID c4b68aff-e95f-47ae-b190-6a671bef1877
Route
VAGINAL
Published
Effective Date 2024-11-12
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

Drug Facts

Purpose

Miconazole nitrate 2% ……………….………………………………….Vaginal antifungal


Medication Information

Purpose

Miconazole nitrate 2% ……………….………………………………….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

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)
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:

    applicator s : insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away 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.
Questions?

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

Inactive Ingredients

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

Principal Display Panel

MONISTAT® 7

Miconazole Nitrate Vaginal Cream (2%)

Vaginal Antifungal

Net Wt. 1.59 oz. (45g) Tube + 7 Disposable Applicators

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 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
Ask A Doctor Or Pharmacist Before Use If

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

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)
Purpose

Miconazole nitrate 2% ……………….………………………………….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:

    applicator s : insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away 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.
Questions?

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

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)

MONISTAT® 7

Miconazole Nitrate Vaginal Cream (2%)

Vaginal Antifungal

Net Wt. 1.59 oz. (45g) Tube + 7 Disposable Applicators

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 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
Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

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


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