Label: MEIJER  MICONAZOLE 3- miconazole nitrate cream 

  • NDC Code(s): 41250-491-09
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each applicator)

    Miconazole Nitrate USP 4% (200 mg in each applicator)

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  • Purpose

    Vaginal antifungal

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  • Use

    • treats vaginal yeast infections
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  • 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 right away.

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  • Directions

    • before using this product read the consumer information leaflet for complete directions and information
    • adults and children 12 years of age and over:
      • insert 1 applicatorful into the vagina at bedtime for 3 nights in a row.
      • Throw applicator away after use.
    • children under 12 years of age: ask a doctor
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  • Other information

    • store at 20°-25°C (68°-77°F)
    • do not purchase if carton is open
    • see end flaps of carton and end of tube for lot number and expiration date
    • the tube opening should be sealed. If seal has been broken, do not use product.
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  • Inactive ingredients

    cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    2929 WALKER AVE NW
    GRAND RAPIDS, MI 49544

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  • PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

    meijer

    COMPARE TO MONISTAT® 3
    active ingredient*

    3 Day
    Treatment

    Miconazole 3
    Miconazole Nitrate Vaginal Cream USP (4%)
    Vaginal Antifungal (Miconazole Nitrate 200 mg per applicator)

    One 25 g (0.9 oz) Tube
    Of 3 Day Vaginal Cream
    & 3 Disposable Applicators

    Cures most vaginal yeast infections

    Consumer Information Leaflet Enclosed

    Principal Display Panel - 25 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    MEIJER   MICONAZOLE 3
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41250-491
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Miconazole Nitrate (Miconazole) Miconazole Nitrate 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    cetyl alcohol  
    isopropyl myristate  
    polysorbate 60  
    polysorbate 80  
    potassium hydroxide  
    propylene glycol  
    water  
    sorbitan monostearate  
    stearyl alcohol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-491-09 1 in 1 CARTON
    1 25 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076773 03/02/2005
    Labeler - Meijer Distribution Inc (006959555)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(41250-491)
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