Label: TOLNAFTATE- antifungal liquid spray aerosol, spray

  • NDC Code(s): 56104-001-02, 56104-001-53
  • Packager: Premier Brands of America Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • if used daily, can prevent recurrence of athlete's foot
    • relieves sypmtoms of athlete's foot, including itching, burning and cracking
  • 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 120ºF

    When using this product

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

    Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

    ​Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 4 weeks

    ​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.

  • ​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 conditions persist, 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 20º and 30ºC (68ºF and 86º)

  • ​Inactive ingredients

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

  • Questions

    Call 1-866-964-0939

  • ​Principal Display Panel

    Premier

    Athlete's Foot

    Antifungal Liquid Spray

    Tolnaftate 1%

    • Cures and prevents most athlete's foot
    • Relieves itching & burning

    For Athlete's Foot

    NET WT 5.3oz(150g)

    PBA Antifungal Liquid Spray Tolnaftate.jpg

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    antifungal liquid spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-001
    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)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOBUTANE (UNII: BXR49TP611)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-001-53150 g in 1 CANISTER; Type 0: Not a Combination Product01/01/2013
    2NDC:56104-001-02150 g in 1 CANISTER; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/01/2013
    Labeler - Premier Brands of America Inc. (117557458)
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