MICONAZOLE 3- miconazole nitrate 
CVS Pharmacy

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Miconazole 3 Complete Pack Kit

Active ingredients

Miconazole nitrate (200 mg in each vaginal insert)

Purpose

Vaginal antifungal

Active ingredients

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 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

• 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.

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)

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

Questions? call toll-free 1-855-590-5695

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

3 VAGINAL SOFTGEL INSERTS, 3 APPLICATORS, 1 EXTERNAL CREAM, 4 FEMININE WIPES
NET WT 3 VAGINAL SOFTGEL INSERTS + 0.32 OZ (9 g) TUBE

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 SUPPOSITORIES (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 (9g) TUBE

MICONAZOLE 3 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-950
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-950-011 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package04/16/1996
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 APPLICATOR
Part 21 TUBE 9 g
Part 1 of 2
MICONAZOLE NITRATE 
miconazole nitrate insert
Product Information
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE200 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
CORN OIL (UNII: 8470G57WFM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/16/1996
Part 2 of 2
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
19 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/16/1996
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/16/1996
Labeler - CVS Pharmacy (062312574)
Registrant - Insight Pharmaceuticals (078774214)

Revised: 1/2017
Document Id: 02e48e12-a4e5-4d00-802f-96225b2c80cb
Set id: 6e027927-1532-46ba-8839-6ee4416d0b60
Version: 3
Effective Time: 20170106
 
CVS Pharmacy