Label: TINACTIN- tolnaftate aerosol, powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use
    • for effective relief of itching, burning and cracking
  • Warnings

    For external use only

    Flammable: Do not use while smoking or near heat or flame

    Do not use on children under 2 years of age unless directed by a doctor.

    When using this product

    • avoid contact with the eyes
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
    • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    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 longer, ask 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
    • in case of clogging, clean nozzle with pin
  • Other information

    store between 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    alcohol denat. (11% v/v), butylated hydroxytoluene, isobutane, PPG-12-buteth-16, talc

  • Questions?

    1-866-360-3266

  • PRINCIPAL DISPLAY PANEL - 133g Can Label

    TOUGH ACTIN' ®

    Tinactin®

    tolnaftate ANTIFUNGAL

    Cures and prevents

    most athlete's foot

    Relieves itching

    & burning

    POWDER SPRAY

    goes on dry

    NET WT 133g (4.6 oz)

    Tinactin AF Powder Spray

  • INGREDIENTS AND APPEARANCE
    TINACTIN 
    tolnaftate aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (White to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0777-2133 g in 1 CAN; Type 0: Not a Combination Product09/23/1993
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/23/1993
    Labeler - Bayer HealthCare LLC. (112117283)
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