Label: MICONAZOLE 3 COMBINATION PACK- miconazole nitrate kit

  • NDC Code(s): 70000-0025-1, 70000-0025-2
  • Packager: Cardinal Health (Leader) 70000
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 7, 2022

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  • Drug Facts

  • Active ingredients

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

  • Purpose

    Vaginal antifungal

    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 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

    • 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. Wash applicator after each use.
      • external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. 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 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).
  • Inactive ingredients

    • suppository: hydrogenated vegetable oil
    • external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
  • Questions?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

    COMPARE TO MONISTAT® 3 active ingredient*

    Miconazole 3

    Combination ack

    Miconazole Nitrate Vaginal Suppositories, SP 200 mg

    and Miconazole Nitrate Vaginal Cream, USP 2%

    Vaginal Antifungal

    Cure Most Vaginal Yeast Infections

    Relieves Associated External Itching and Irritation

    3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg with 3 Disposable Applicators Plus

    1 Tube of Miconazole Nitrate Vaginal cream, USP 2%

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

    DISTRIBUTED BY

    CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

  • Package label

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

    LEADER Miconazole 3 Cream and Miconazole Nitrate Vaginal Suppositories

  • Package label

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

    LEADER Miconazole 3 Combination Pack

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 3 COMBINATION PACK 
    miconazole nitrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0025
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0025-11 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product07/01/2019
    2NDC:70000-0025-21 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product07/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 3 
    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
    ANDAANDA07492607/01/2019
    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
    ANDAANDA07492607/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07492607/01/2019
    Labeler - Cardinal Health (Leader) 70000 (063997360)
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