Miconazole 3

Miconazole 3
SPL v3
SPL
SPL Set ID 12a2e441-4fdf-4c5e-b033-ba05ef12fc2f
Route
VAGINAL
Published
Effective Date 2020-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (40 mg)
Inactive Ingredients
Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Polysorbate 80 Potassium Hydroxide Propylene Glycol Water Sorbitan Monostearate Stearyl Alcohol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2005-03-02

Description

Drug Facts

Purpose

Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Description

Drug Facts

Use
  • treats vaginal yeast infections
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

Section 50570-1

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

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:
    • insert 1 applicatorful into the vagina at bedtime for 3 nights in a row.

      Throw applicator away after use.
  • children under 12 years of age: ask a doctor
Questions?

call 1-866-923-4914

Active Ingredient

Miconazole nitrate USP 4%

Other Information
  • do not use if seal over tube opening has been punctured
  • do not purchase if carton is open
  • store at 20° to 25°C (68° to 77°F)
  • see end flaps of carton and end of tube for lot number and expiration date
Inactive Ingredients

cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and 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 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
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
Principal Display Panel 25 G Tube Carton

NDC 11673-391-06

Compare to the active ingredient in Monistat ®3*

up&up

3-day treatment

miconazole 3

miconazole nitrate vaginal cream USP (4%)

vaginal antifungal

cures most vaginal yeast infections

ONE 0.9 OZ (25 g) TUBE OF 3 DAY VAGINAL CREAM AND THREE DISPOSABLE APPLICATORS


Structured Label Content

Use
  • treats vaginal yeast infections
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

Section 50570-1 (50570-1)

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

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:
    • insert 1 applicatorful into the vagina at bedtime for 3 nights in a row.

      Throw applicator away after use.
  • children under 12 years of age: ask a doctor
Questions?

call 1-866-923-4914

Active Ingredient (Active ingredient)

Miconazole nitrate USP 4%

Other Information (Other information)
  • do not use if seal over tube opening has been punctured
  • do not purchase if carton is open
  • store at 20° to 25°C (68° to 77°F)
  • see end flaps of carton and end of tube for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and 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 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
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
Principal Display Panel 25 G Tube Carton (PRINCIPAL DISPLAY PANEL - 25 g Tube Carton)

NDC 11673-391-06

Compare to the active ingredient in Monistat ®3*

up&up

3-day treatment

miconazole 3

miconazole nitrate vaginal cream USP (4%)

vaginal antifungal

cures most vaginal yeast infections

ONE 0.9 OZ (25 g) TUBE OF 3 DAY VAGINAL CREAM AND THREE DISPOSABLE APPLICATORS


Advanced Ingredient Data


Raw Label Data

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