Label: 7 DAY VAGINAL - miconazole nitrate cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 01/11

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

  • Active Ingredient

    Miconazole nitrate 2% (100 mg in each applicator)
    Miconazole nitrate 2% (as external cream)

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  • Purpose

    Vaginal antifungal

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  • Uses

    • treats repeat vaginal yeast infections

    • relieves external itching and irritation due to a repeat vaginal yeast infection

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  • Warnings

    For vaginal use only

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  • Do not use

    if you have never had a vaginal yeast infection diagnosed by a doctor

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  • 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.
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  • Ask a doctor or pharmacist before use if you are

    taking the prescription blood thinning medication warfarin, because bleeding or bruising may occur.

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  • When using this product

    • do not use tampons, douches, spermicides, or other vaginal products

    • do not have vaginal intercourse

    • condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)

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  • 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

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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • 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 enclosed consumer information leaflet for complete instructions

    • adults and children 12 years of age and over:

      • applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
      • external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use daily for up to 7 days as needed
    • children under 12 years of age: ask a doctor

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  • Other information

    • do not use if seal over tube opening has been punctured or cannot be seen

    • store at room temperature 15°-30°C (59-86°F). Avoid heat over 30°C or 86°F.

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  • Inactive ingredients

    benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

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  • Questions?

    1-800-200-6313

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  • PRINCIPAL DISPLAY PANEL

    NDC 37205-590-29

    LEADER®

    7 DAY VAGINAL CREAM
    Miconazole NitrateVAGINAL CREAM 2% • VAGINAL ANTIFUNGAL

    Cures most vaginal yeast infections.
    Relieves external vulvar itching and irritation associated with a yeast infection


    Compare to Monistat® 7 active ingredient*

    NET WT 1.59 OZ (45 g)

    SATISFACTION GUARANTEED

    DISTRIBUTED BY
    CARDINAL HEALTH
    DUBLIN, OH 43017
    CIN 1362490

    www.myleader.com
    1-800-200-6313

    All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

    *This product is not manufactured or distributed by Johnson & Johnson, distributor or manufacturer of MONISTAT® 7. MONISTAT® 7 is a registered trademark of Johnson & Johnson.

    10-25237LR2

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  • INGREDIENTS AND APPEARANCE
    7 DAY VAGINAL  
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-590
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Miconazole Nitrate (Miconazole) Miconazole Nitrate 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Benzoic Acid  
    Butylated Hydroxyanisole  
    Mineral Oil  
    Peg-5 Oleate  
    Pegoxol 7 Stearate  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-590-29 45 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 03/16/2009
    Labeler - Cardinal Health (097537435)
    Registrant - G & W Laboratories, Inc. (001271188)
    Establishment
    Name Address ID/FEI Business Operations
    G & W Laboratories, Inc. 001271188 MANUFACTURE(37205-590)
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