MICONAZOLE 3 COMBINATION PACK- miconazole nitrate 
Major Pharmaceuticals

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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

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 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

Other information

Inactive ingredients

Questions?

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

Principal Display Panel

MAJOR®

NDC 0904-5415-01

MICONAZOLE 3
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP (200 MG)
& MICONAZOLE NITRATE VAGINAL CREAM, USP 2% VAGINAL ANTIFUNGAL

COMBINATION PACK

CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING & IRRITATION

COMPARE TO the active ingredient in MONISTAT® 3*

3 MICONAZOLE NITRATE
VAGINAL SUPPOSITORIES,
USP 200 mg PLUS 1 TUBE OF
MICONAZOLE NITRATE VAGINAL
CREAM, USP 2%

NET WT. 0.32 OZ (9g) TUBE

image
MICONAZOLE 3 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5415
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5415-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product12/02/2002
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 3   in 0 
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
ANDAANDA07492612/02/2002
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
ANDAANDA07492612/02/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07492612/02/2002
Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2019
Document Id: de71a78b-ce17-4947-9646-9dc463e01ab4
Set id: 56ca3b01-2907-4ef6-b7f3-cdcdedbd40c3
Version: 9
Effective Time: 20191118
 
Major Pharmaceuticals