Miconazole Nitrate

Miconazole Nitrate
SPL v4
SPL
SPL Set ID 6b34d0be-4bcd-4dff-b732-7fbd46765019
Route
VAGINAL
Published
Effective Date 2020-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Butylated Hydroxytoluene Mineral Oil Water Benzoic Acid

Identifiers & Packaging

Marketing Status
ANDA Active Since 1997-01-13

Description

Drug Facts

Purpose

Vaginal antifungal


Medication Information

Purpose

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

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:
    • 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 to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.
  • children under 12 years of age: ask a doctor
Questions?

call 1-866-923-4914

Active Ingredient

Miconazole nitrate USP 2% (100 mg in each applicatorful)

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

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.

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 45 G Tube Carton

CURES most vaginal YEAST INFECTIONS

Relieves associated external itching and irritation

NDC 51672-2035-6

7 Day Treatment

7 Day Vaginal Cream

Miconazole Nitrate Vaginal Cream USP (2%)

(Miconazole Nitrate 100 mg per application)

Vaginal Antifungal

One 45 g (1.5 oz) tube of Miconazole Nitrate Vaginal Cream USP (2%)

& 1 Reusable Applicator

Consumer Information Leaflet Enclosed


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

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:
    • 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 to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.
  • children under 12 years of age: ask a doctor
Questions?

call 1-866-923-4914

Active Ingredient (Active ingredient)

Miconazole nitrate USP 2% (100 mg in each applicatorful)

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

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.

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 45 G Tube Carton (PRINCIPAL DISPLAY PANEL - 45 g Tube Carton)

CURES most vaginal YEAST INFECTIONS

Relieves associated external itching and irritation

NDC 51672-2035-6

7 Day Treatment

7 Day Vaginal Cream

Miconazole Nitrate Vaginal Cream USP (2%)

(Miconazole Nitrate 100 mg per application)

Vaginal Antifungal

One 45 g (1.5 oz) tube of Miconazole Nitrate Vaginal Cream USP (2%)

& 1 Reusable Applicator

Consumer Information Leaflet Enclosed


Advanced Ingredient Data


Raw Label Data

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