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NDC 37205-0589-03 Miconazole 3 Combination Pack Details

Miconazole 3 Combination Pack

Miconazole 3 Combination Pack is a VAGINAL KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 37205. The primary component is .

MedlinePlus Drug Summary

Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Related Packages: 37205-0589-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miconazole Vaginal

Product Information

NDC	37205-0589
Product ID	37205-589_e4de4653-3527-47f5-b049-b49271d5cee9
Associated GPIs	55104050106410
GCN Sequence Number	007006
GCN Sequence Number Description	miconazole nitrate KIT 200 MG-2 % VAGINAL
HIC3	Q4F
HIC3 Description	VAGINAL ANTIFUNGALS
GCN	69380
HICL Sequence Number	003031
HICL Sequence Number Description	MICONAZOLE NITRATE
Brand/Generic	Generic
Proprietary Name	Miconazole 3 Combination Pack
Proprietary Name Suffix	n/a
Non-Proprietary Name	miconazole nitrate
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	VAGINAL
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Cardinal Health (Leader) 37205
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA074926
Listing Certified Through	2024-12-31

Package

Package Images

NDC 37205-0589-03 (37205058903)

Pricing Information	N/A
NDC Package Code	37205-589-03
Billing NDC	37205058903
Package	1 KIT in 1 PACKAGE, COMBINATION (37205-589-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE
Marketing Start Date	2001-02-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b70b6091-1aff-4d93-99aa-5c309221ec5d Details

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 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 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. Gently 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 room temperature 15°-30°C (59°-86°F). Avoid heat (over 30°C - 86°F)

Inactive ingredients

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

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Principal Display Panel

NDC 37205-589-03

LEADER®

3 DAY TREATMENT

Reusable Applicator

VAGINAL SUPPOSITORIES plus CREAM for EXTERNAL RELIEF

Compare to

Monistat® 3

active ingredient*

Miconazole 3

Combination Pack

Miconazole Nitrate Vaginal Suppositories, USP 200 mg and

Miconazole Nitrate External Vulvar Cream, 2%

VAGINAL ANTIFUNGAL

Cures most vaginal yeast infections

Relieves associated external itching and irritation

3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg plus

1 tube of Miconazole Nitrate External Vulvar Cream - NET WT 0.32 oz (9 g)

INGREDIENTS AND APPEARANCE

MICONAZOLE 3 COMBINATION PACK

miconazole nitrate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-589

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-589-03	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	02/02/2001

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074926	02/02/2001

Part 2 of 2
MICONAZOLE 3 miconazole nitrate cream

Product Information
Route of Administration	VAGINAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074926	02/02/2001

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074926	02/02/2001

Labeler - Cardinal Health (Leader) 37205 (097537435)

Revised: 11/2022

Document Id: e4de4653-3527-47f5-b049-b49271d5cee9

Set id: b70b6091-1aff-4d93-99aa-5c309221ec5d

Version: 8

Effective Time: 20221118