Label: TOLNAFTATE- tolnaftate jock itch powder spray - talc free aerosol, spray

  • NDC Code(s): 56104-037-46
  • 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 jock itch (tinea cruis)
    • relieves itching, burning and crafing associated with jock itch
  • 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

    • do not get into eyes or mouth, if products get into eyes, rinse eyes thoroughly with water
    • 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 2 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
    • use daily for 2 weeks; if conditions persist, consult a doctor
    • if nozzle clogs, clean with a pin
  • Other information

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

  • Inactive ingredients

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

  • Questions?

    call 1-866-964-0939

  • Prinicipal Display Panel

    Premier

    Jock Itch Powder Spray

    Tolnaftate Antifungal

    Cures most jock itch

    Relieves itching, chafing and burning

    TALC-FREE

    NET WT 4.6 OZ (130 g)

    JOCK ITCH

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    tolnaftate jock itch powder spray - talc free aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-037
    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:56104-037-46130 g in 1 CAN; Type 0: Not a Combination Product10/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/31/2017
    Labeler - Premier Brands of America Inc. (117557458)
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