Label: LEADER MEDICATED- tolnaftate aerosol, 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

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

  • Active ingredient

    Tolnaftate 1%

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  • Purpose

    Antifungal

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  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor

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  • Uses

    Uses

    • cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
    • if used daily, can prvent recurrance of athlete's foot
    • relieves symptoms of athlete's foot, including itching, burning and cracking
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  • Warnings

    For external use only.

    Flammable:

    Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120o F

    When using this product

    • do not get into eyes or mouth
    • use only as directed; intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal

    ​Stop use and ask a doctor if

    • irritation occurs
    • no improvement after four weeks for athlete's foot,
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  • Directions

    • wash affected area and dry thoroughly
    • shake can well and spray a thin layer over affected area twice daily (morning and night)
    • 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
    • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if condition persists, consult a doctor
    • to prevent athlete's foot, apply daily (morning and night)
    • this product is not effective on scalp or nails
    • in case of clogging, clear nozzle under running water
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  • Other infomation

    Store between 20o and 30o C (68o and 86o F)

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  • Inactive ingredients

    SD alcohol 40-B (14% w/w), BHT, Isobutane (propellant), PPG-12-buteth-16, talc

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  • Questions

    Call 1-866-964-0939

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  • Box Label

    Leader Tolnaftate 1%  Medicated Powder SprayLeader Medicated Tolnaftate 1% Powder Spray

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  • INGREDIENTS AND APPEARANCE
    LEADER MEDICATED 
    tolnaftate aerosol, powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-344
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL 0.14 g  in 1 g
    ISOBUTANE  
    PPG-12-BUTETH-16  
    TALC  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-344-66 130 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 03/15/2008
    Labeler - Cardinal Health Inc. (097537435)
    Registrant - Premier Brands of America (063849780)
    Establishment
    Name Address ID/FEI Business Operations
    Premier Brands of America 063849780 repack(37205-344), relabel(37205-344)
    Establishment
    Name Address ID/FEI Business Operations
    American Spray Tech LLC 137135237 manufacture(37205-344)
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