Topcare Miconazole 3

Dosage Form: vaginal suppositories, external cream
Topco Miconazole 3 Drug Facts

Active ingredient

Miconazole nitrate (200 mg in each suppository)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

Uses

• treats vaginal yeast infections


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

Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

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 a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

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

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.

Directions

• before using this product read the enclosed consumer information leaflet for complete instructions and information


• adults and children 12 years of age and over:


• suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.


• external cream: 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

Other information

• do not use if printed suppository wrapper is missing or damaged (each suppository is individually wrapped)


• do not use if seal over tube opening has been punctured or cannot be seen


• do not purchase if carton is open


• store at 20°-25°C (68°-77°F)

Inactive ingredients

suppository: hydrogenated vegetable oil

external cream: benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions or comments?

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Vaginal Suppositories

Miconazole 3

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Cream (2%)

Vaginal Antifungal

Combination Pack

(Miconazole Nitrate 200 mg per Suppository Plus 2% External Vulvar Cream)

Cures Most Vaginal Yeast Infections

Relieves Associated External Itching and Irritation

3 Vaginal Suppositories with 3 Disposable Applicators plus External Vulvar Cream

Compare to Monistat® 3 active ingredients

Miconazole 3 Carton

Topcare Miconazole 3  COMBINATION PACK miconazole nitrate  kit

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-081

Packaging # NDC Package Description Multilevel Packaging 1 36800-081-00 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK   3  Part 2 1 TUBE   9 g

Part 1 of 2 MICONAZOLE  miconazole nitrate  suppository

Product Information       Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 200 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE (to off white, opaque) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 1 BLISTER PACK In 1 KIT contains a BLISTER PACK 1 3 SUPPOSITORY In 1 BLISTER PACK This package is contained within the KIT

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075329 05/10/2000

Part 2 of 2 MICONAZOLE  miconazole nitrate  cream

Product Information       Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 2 g  in 100 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 1 TUBE In 1 KIT contains a TUBE 1 9 g In 1 TUBE This package is contained within the KIT

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075329 05/10/2000

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075329	05/10/2000

Labeler - Topco Associates LLC (006935977)

Revised: 09/2009Topco Associates LLC

More Topcare Miconazole 3 resources

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