7 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH]

7 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH]
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NDC 37205-590-29
Set ID 1b95ccd9-ce8d-50cb-2db1-05ad9924811a
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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 Item Code (Source) NDC:37205-590
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Butylated Hydroxyanisole (UNII: REK4960K2U)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Peg-5 Oleate (UNII: 0240V77G50)  
    Pegoxol 7 Stearate (UNII: 3EW5AXE5X5)  
    Water (UNII: 059QF0KO0R)  
    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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