Miconazole 7

Miconazole 7
SPL v5
SPL
SPL Set ID edaca770-bc76-4ac2-bad2-cf8e7de0c682
Route
VAGINAL
Published
Effective Date 2019-11-27
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

Use
  • 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 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:
    • applicators:insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after each 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 1-800-910-6874

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

To open:unscrew cap, use pointed end on cap to puncture seal

To close:screw cap back onto the tube

  • store at 20°-25°C (68°-77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

Apricot Kernel Oil/PEG-6, Butylated Hydroxytoluene, Mineral Oil, PEG-6-32 Stearate/Glycol Stearate, Purified Water and Benzoic Acid (0.20%) as a preservative

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

up&up

NDC 11673-049-06

7 DISPOSABLE APPLICATORS

7-DAY VAGINAL CREAM

Compare to active ingredient in Monistat ®7*

7-day treatment

miconazole 7

miconazole nitrate vaginal cream USP (2%)

(miconazole nitrate 100 mg per application)

vaginal antifungal

cures most vaginal yeast infections and relieves

associated external itching and irritation

7-day vaginal cream with disposable applicators

educational brochure enclosed

NET WT 1.5 OZ (45 g) TUBE + 7 DISPOSABLE APPLICATORS


Structured Label Content

Use
  • 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 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:
    • applicators:insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after each 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 1-800-910-6874

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

To open:unscrew cap, use pointed end on cap to puncture seal

To close:screw cap back onto the tube

  • store at 20°-25°C (68°-77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

Apricot Kernel Oil/PEG-6, Butylated Hydroxytoluene, Mineral Oil, PEG-6-32 Stearate/Glycol Stearate, Purified Water and Benzoic Acid (0.20%) as a preservative

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)

up&up

NDC 11673-049-06

7 DISPOSABLE APPLICATORS

7-DAY VAGINAL CREAM

Compare to active ingredient in Monistat ®7*

7-day treatment

miconazole 7

miconazole nitrate vaginal cream USP (2%)

(miconazole nitrate 100 mg per application)

vaginal antifungal

cures most vaginal yeast infections and relieves

associated external itching and irritation

7-day vaginal cream with disposable applicators

educational brochure enclosed

NET WT 1.5 OZ (45 g) TUBE + 7 DISPOSABLE APPLICATORS


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