Label: LEADER MEDICATED- miconazole nitrate powder

  • 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 10/12

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  • Active ingredient

    Miconozole nitrate2%

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  • Purpose

    Antifungal

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  • INDICATIONS & USAGE

    Uses

    for the cure of most athlete's foot, jock itch and ringworm

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  • Warnings

    For external use only.

    Do not use

    on children under 2 years of age unless directed by a doctor

    When using this product

    do not get into eyes.

    Stop use and ask a doctor if

    if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

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  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away. ‚Äč

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  • Directions

    • clean and dry affected area
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product
    • for athlete's foot, pay special attention to spaces between toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • for athlete's foot and ringworm, use daily for 4 weeks ; for jock itch, use daily for 2 weeks
    • if condition persists, consult a doctor
    • this product is not effective on scalp or nails
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  • Other infomation

    Product settles during shipment. Package contains full net weight.

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  • Inactive ingredients

    aldioxa, chloroxylenol, fragrance, imidurea, powdered cellulose, talc. Contains no starch

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  • Questions

    Call 1-866-964-0939

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  • Box Label

    Leader Medicated Miconazole Nitrate 2% PowderLeader Medicated Miconazole Nitrate 2% Powder Spray

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  • INGREDIENTS AND APPEARANCE
    LEADER MEDICATED 
    miconazole nitrate powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-653
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE 1.42 g  in 71 g
    Inactive Ingredients
    Ingredient Name Strength
    ALDIOXA  
    CHLOROXYLENOL  
    IMIDUREA  
    POWDERED CELLULOSE  
    TALC  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-653-18 71 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 10/31/2010
    Labeler - Cardinal Health Inc. (097537435)
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