Label: LEADER MEDICATED- miconazole nitrate powder

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 31, 2012

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  • Active ingredient

    Miconozole nitrate2%

  • Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses

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

  • 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.

  • Keep out of reach of children

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

  • 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
  • Other infomation

    Product settles during shipment. Package contains full net weight.

  • Inactive ingredients

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

  • Questions

    Call 1-866-964-0939

  • Box Label

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

  • INGREDIENTS AND APPEARANCE
    LEADER MEDICATED 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-653
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE1.42 g  in 71 g
    Inactive Ingredients
    Ingredient NameStrength
    ALDIOXA (UNII: 8T66I31YNK)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-653-1871 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/31/2010
    Labeler - Cardinal Health Inc. (097537435)
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