MICONAZOLE 3 WALGREEN COMPANY- miconazole nitrate 
WALGREEN COMPANY

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Miconazole 3 Combination Pack

Drug Facts

Active ingredients

Miconazole nitrate (200 mg in each vaginal insert)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

Vaginal antifungal

Uses

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 (1-800-222-1222) right away.

Directions

Other Information

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

- Kit Carton

Miconazole 3

Miconazole Nitrate Vaginal Inserts (200 mg)

Miconazole Nitrate Cream (2%) 

Vaginal Antifungal | 3-Day Treatment

Net Wt. 0.32 oz (9 g) Tube & 3 Ovule Inserts

PRINCIPAL DISPLAY PANEL
- Kit Carton

Miconazole 3
Miconazole Nitrate Vaginal Inserts (200 mg) 
Miconazole Nitrate Cream (2%) 

Vaginal Antifungal | 3-Day Treatment


Net Wt. 0.32 oz (9 g) Tube & 3 Ovule Inserts

MICONAZOLE 3  WALGREEN COMPANY
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5203
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-5203-011 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package04/18/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 APPLICATOR
Part 21 TUBE 9 g
Part 1 of 2
MICONAZOLE NITRATE 
miconazole nitrate suppository
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
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 PACKAGE
11 in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/18/2016
Part 2 of 2
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 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
NDANDA02067004/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/18/2016
Labeler - WALGREEN COMPANY (008965063)
Registrant - Insight Pharmaceuticals (055665422)

Revised: 11/2021
Document Id: 0aac96ec-3f46-484d-9714-99b5f67d332b
Set id: 32b373be-9c8e-49b0-a796-8d87f6a20cef
Version: 1
Effective Time: 20211108
 
WALGREEN COMPANY