MICONAZOLE 3 COMBINATION PACK- miconazole nitrate 
Wakefern Food Corporation

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Miconazole 3 Combination Pack

Drug Facts

Active ingredients

Miconazole nitrate (200 mg in each suppository)
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

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. Throw applicator away after 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, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions?

1-800-SHOPRITE

Principal Display Panel

Shop Rite®
Cures Most Vaginal Yeast Infections
And Relieves Associated External
Itching And Irritation
miconazole 3

MICONAZOLE NITRATE VAGINAL SUPPOSITORIES (200 mg) and MICONAZOLE NITRATE CREAM (2%)
•VAGINAL ANTIFUNGAL •COMBINATION PACK
(MICONAZOLE NITRATE 200 mg PER SUPPOSITORY PLUS 2% EXTERNAL VULVAR CREAM)

3 Miconazole Nitrate Vaginal
Suppositories USP, 200 mg
plus 1 tube of Miconazole Nitrate
External Vulvar Cream

3- Day
Treatment

3 Vaginal Suppositories +
NET WT 0.32 (9g) Tube

shoprite miconazole carton1
MICONAZOLE 3 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-731
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41190-731-431 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product05/29/200702/28/2018
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
ANDAANDA07492605/29/200702/28/2018
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
ANDAANDA07492605/29/200702/28/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07492605/29/200702/28/2018
Labeler - Wakefern Food Corporation (069722418)

Revised: 12/2017
 
Wakefern Food Corporation