Label: PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE POWDER- tolnaftate powder spray aerosol, spray

  • NDC Code(s): 56104-248-01
  • 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 most athelete's foot (tinea pedis) and ringworm (tinea corporis)
    • prevents the recurrence of most athelete's foot with daily use
    • for effective relief of itching, cracking and burning
  • Warnings

    For external use only.

    Flammable:

    Contents under pressure. Avoid Spraying 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

    • if irritation occurs
    • no improvement within 4 weeks for athlete's foot and ringworm

    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) 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 conditions persist, consult a doctor
    • to prevent athlete's foot: wash the feet and dry throughly; spray a thing 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, clean with a pin
  • Other information

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

  • Inactive ingredients

    BHT, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B, Zea Mays (Corn) Starch

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    Meijer

    Antifungal

    Athlete's Foot

    Powder Spray

    Tolnaftate 1%

    • Cures most athlete's foot
    • Relieves itching & burning
    • Talc free

    NET WT 4.6 OZ (130g)

    image 1

  • INGREDIENTS AND APPEARANCE
    PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE POWDER 
    tolnaftate powder spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-248
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.3 g  in 130 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOBUTANE (UNII: BXR49TP611)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    ALCOHOL (UNII: 3K9958V90M)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-248-01130 g in 1 CAN; Type 0: Not a Combination Product03/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/11/2022
    Labeler - Premier Brands of America Inc. (117557458)
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