Label: PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE LIQUID- tolnaftate aerosol, spray

  • NDC Code(s): 56104-247-01
  • 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

    • 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:

    Contents under pressure. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate.

    Do not store at temperature above 120ºF. Keep out of reach of children. Use only as directed. 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 for athlete's foot and ringworm

    ​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) or as directed by a doctor
    • 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
    • for athlete's foot and ringworm, use daily for 4 weeks
    • if condition persists, consult a doctor
    • to prevent athlete's foot, wash the feet and dry thoroughly; spray a thin layer of the product to the feet once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails
    • if nozzle clogs, clear with a pin
  • ​Other information

    store between 20º and 30ºC (68º and 86ºF)

  • ​Inactive ingredients

    BHT, isobutane, PPG-12-buteth-16, SD alcohol 40-B

  • ​ ​Questions?

    Call 1-866-964-0939

  • ​Principal Display Panel

    ​Premier Solutions​

    Antifungal

    Athlete's Foot

    Liquid Spray

    Tolnaftate 1%

    Cures most athlete's foot and prevents recurrences

    Relieves itching, cracking and burning

    Net WT 5.3 OZ (150g)

    Image 1

  • INGREDIENTS AND APPEARANCE
    PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE LIQUID 
    tolnaftate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-247
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.15 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:56104-247-01150 g in 1 CAN; Type 0: Not a Combination Product06/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/16/2022
    Labeler - Premier Brands of America, Inc. (117557458)
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