Miconazole 3 Complete Pack Kit

Miconazole 3 Complete Pack Kit
SPL v3
SPL
SPL Set ID 6e027927-1532-46ba-8839-6ee4416d0b60
Routes
VAGINAL TOPICAL
Published
Effective Date 2017-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (200 mg)
Inactive Ingredients
Gelatin Glycerin Corn Oil Titanium Dioxide Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Active Since 1996-04-16

Description

Miconazole nitrate (200 mg in each vaginal insert)

Purpose

Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Description

Miconazole nitrate (200 mg in each vaginal insert)

Uses

• treats vaginal yeast infections

• relieves external itching and irritation due to a vaginal yeast infection

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:

•vaginal insert : with a disposable applicator place the insert into the vagina at bedtime. 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 (vulva). Use 2 times daily for up to 7 days, as needed.

children under 12 years of age: ask a doctor

Other Information

•do not use if printed sealed pouches containing vaginal inserts are torn, open, or incompletely sealed

•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)

Active Ingredients

Miconazole nitrate (200 mg in each vaginal insert)

Inactive Ingredients

vaginal insert : gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

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

Principal Display Panel

Compare to the active ingredients of Monistat® 3

3-Day Treatment; 3-Step System

Yeast Infection Relief

Miconazole 3

MICONAZOLE NITRATE VAGINAL INSERTS (200 mg)

MICONAZOLE NITRATE CREAM (2%)

Vaginal Antifungal

Combination Pack

  • Cures most vaginal yeast infections

  • Relieves associated external itching & irritation

3 VAGINAL SOFTGEL INSERTS, 3 APPLICATORS, 1 EXTERNAL CREAM, 4 FEMININE WIPES

NET WT 3 VAGINAL SOFTGEL INSERTS + 0.32 OZ (9 g) TUBE

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 You Are

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

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:

•vaginal insert : with a disposable applicator place the insert into the vagina at bedtime. 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 (vulva). Use 2 times daily for up to 7 days, as needed.

children under 12 years of age: ask a doctor

Other Information

•do not use if printed sealed pouches containing vaginal inserts are torn, open, or incompletely sealed

•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)

Active Ingredients (Active ingredients)

Miconazole nitrate (200 mg in each vaginal insert)

Inactive Ingredients (Inactive ingredients)

vaginal insert : gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredients of Monistat® 3

3-Day Treatment; 3-Step System

Yeast Infection Relief

Miconazole 3

MICONAZOLE NITRATE VAGINAL INSERTS (200 mg)

MICONAZOLE NITRATE CREAM (2%)

Vaginal Antifungal

Combination Pack

  • Cures most vaginal yeast infections

  • Relieves associated external itching & irritation

3 VAGINAL SOFTGEL INSERTS, 3 APPLICATORS, 1 EXTERNAL CREAM, 4 FEMININE WIPES

NET WT 3 VAGINAL SOFTGEL INSERTS + 0.32 OZ (9 g) TUBE

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 You Are (Ask a doctor or pharmacist before use if you are)

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


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