Label: TOLNAFTATE- antifungal liquid spray aerosol, spray

  • NDC Code(s): 63868-798-53
  • Packager: Chain Drug Marketing Association
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 2, 2024

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • prevents the recurrence of most athlete's foot with daily use
    • for effective relief of itching, cracking and burning
  • 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 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    When using this product

    • avoid contact with the eyes or mouth
    • use only as directed

    Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 4 weeks

    Do not use

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

    Keep out of reach of children.

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

  • 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 the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
    • use daily for 4 weeks
    • if condition persists, consult a doctor
    • to prevent athlete's foot, apply once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails
  • Other information

    store between 20° and 30°C (68° and 86°F)

  • Inactive ingredients

    BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B (36% w/w)

  • Questions?

    Call 1-248-449-9300

  • Principal Display Panel

    Quality Choice

    Athlete's

    Foot Relief

    Antifungal Liquid Spray

    Tolnaftate 1%

    Cures most athlete's foot & prevents recurrences

    Relieves itching, cracking & burning

    NET WT

    5.3 OZ (150 g)

    antifungal tolnaftate liquid spray

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    antifungal liquid spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-798
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.5 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTANE (UNII: BXR49TP611)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-798-53150 g in 1 CAN; Type 0: Not a Combination Product12/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00512/01/2014
    Labeler - Chain Drug Marketing Association (011920774)
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