MICONAZOLE 3 COMBINATION PACK- miconazole nitrate kit

Miconazole 3 Combination Pack by

Drug Labeling and Warnings

Miconazole 3 Combination Pack by is a Otc medication manufactured, distributed, or labeled by Cardinal Health (Leader) 70000. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Miconazole nitrate, USP 200 mg (in each suppository)
Miconazole nitrate, USP 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 the prescription blood thinning medicine, warfarin, because bleeding and 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 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 - 1 Applicator Carton

• before using this product read the enclosed consumer information leaflet for complete directions 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. Wash applicator after each use.
  • external cream: Use cap to puncture seal. 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

Directions - 3 Applicator Carton

• before using this product read the enclosed consumer information leaflet for complete directions 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: Use cap to puncture seal. 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 suppository wrapper is missing or damaged (each suppository is individually wrapped)
• do not use if seal over tube opening has been punctured or is not visible
• do not purchase if carton is open
• store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).

Inactive ingredients

• suppository: hydrogenated vegetable oil
• external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.

Principal Display Panel

LEADER™

NDC: 70000-0025-1

Miconazole 3
Combination Pack
Miconazole Nitrate Vaginal Suppositories, USP 200 MG
and Miconazole Nitrate Vaginal Cream, USP 2%
Vaginal Antifungal

Cures Most Vaginal Yeast Infections
Relieves Associated External Itching and Irritation

COMPARE TO MONISTAT® 3 active ingredient*
100% Money Back Guarantee

3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg Plus
1 Tube of Miconazole Nitrate Vaginal Cream, USP 2% - NET WT 0.32 OZ (9 g)

3 Day Treatment

3 Vaginal Suppositories with Reusable Applicator
Plus External Cream for Itch Relief

Principal Display Panel

LEADER™

NDC: 70000-0025-2

Miconazole 3
Combination Pack
Miconazole Nitrate Vaginal Suppositories, USP 200 MG
and Miconazole Nitrate Vaginal Cream, USP 2%
Vaginal Antifungal

Cures Most Vaginal Yeast Infections
Relieves Associated External Itching and Irritation

COMPARE TO MONISTAT® 3 active ingredient*
100% Money Back Guarantee

3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg Plus
1 Tube of Miconazole Nitrate Vaginal Cream, USP 2% - NET WT 0.32 OZ (9 g)

3 Day Treatment

3 Vaginal Suppositories with Disposable Applicators
Plus External Cream for Itch Relief

INGREDIENTS AND APPEARANCE

MICONAZOLE 3 COMBINATION PACK 
miconazole nitrate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0025

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0025-1	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	07/01/2019
2	NDC: 70000-0025-2	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	07/01/2019

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 3 
miconazole nitrate suppository

Product Information
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	200 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074926	07/01/2019

Part 2 of 2

MICONAZOLE 3 
miconazole nitrate cream

Product Information
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	10 mg  in 0.5 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
MINERAL OIL (UNII: T5L8T28FGP)
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074926	07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074926	07/01/2019

Labeler - Cardinal Health (Leader) 70000 (097537435)