MICONAZOLE 3 COMBINATION PACK- miconazole nitrate 
EQUATE (Wal-Mart Stores, Inc.)

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Miconazole 3 Combination Pack

Drug Facts

Active ingredients

Miconazole nitrate, USP 200 mg (in each suppository)
Miconazole nitrate, USP 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

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

Other information

Inactive ingredients

Questions?

1-888-287-1915

Principal Display Panel

Compare to Monistat® 3 active ingredient*

3 Day Treatment

Miconazole

Combination Pack

Vaginal antifungal

Miconazole nitrate vaginal suppositories, USP 200 mg

and Miconazole nitrate vaginal cream, USP 2%

Vaginal Antifungal

3 miconazole nitrate vaginal suppositories, USP 200 mg with 1 reusable applicator plus

1 tube of miconazole nitrate vaginal cream, USP 2%

Net wt. oz (g)

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® 3.

Distributed by:

Wal-Mart Inc

Bentonville AR 72716

Package Label

Miconazole Nitrate, USP 200 mg (in each suppository) Miconazole Nitrate, USP 2% (external cream)

EQUATE Miconazole 3 Day Combination Pack Treatment

MICONAZOLE 3 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-345
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-345-031 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product05/01/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 TUBE 9 g
Part 1 of 2
MICONAZOLE 3 
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
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07492605/01/2020
Part 2 of 2
MICONAZOLE 3 
miconazole nitrate cream
Product Information
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE10 mg  in 0.5 g
Inactive Ingredients
Ingredient NameStrength
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 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
ANDAANDA07492605/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07492605/01/2020
Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Revised: 7/2021
Document Id: 89d12d5b-2075-49a4-b8a4-b2ba85de8860
Set id: 50f2a26c-8203-4a10-8d0d-ad0f9fadb6bc
Version: 2
Effective Time: 20210721
 
EQUATE (Wal-Mart Stores, Inc.)