Label: TOLNAFTATE- tolnaftate athletes foot powder spray spray

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 30, 2023

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most
    • athlete’s foot (tinea pedis)
    • ringworm (tinea corporis)
    • effectively soothes and relieves
    • itching
    • burning
    • cracking
    • helps prevent most athlete’s foot from coming back with daily use
  • Warnings

    For external use only

    Flammable: Do not use near flame or spark or while smoking.

    Do not use

    on children under 2 years of age unless directed by a doctor

    When using this product

    • avoid contact with the eyes
    • contents under pressure. Do not puncture or incinerate or store at temperatures above 120°F (49°C).
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    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

    • clean the affected area and dry thoroughly
    • shake can well before use
    • hold can about 6 inches from the area to be treated
    • spray a thin layer over the 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 lasts longer, ask a doctor.
    • to prevent athlete’s foot, apply to the feet 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 a pin
  • Inactive ingredients

    alcohol SD 40-B, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propane, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Athlete’s Foot

    Antifungal

    Powder Spray

    Tolnaftate 1%

    Cures & prevents most athlete’s foot

    Relieves itching & burning

    NET WT 4.6 OZ (130g)

    Artwork

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    tolnaftate athletes foot powder spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1746
    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)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    ALCOHOL (UNII: 3K9958V90M)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1746-00130 g in 1 CAN; Type 0: Not a Combination Product10/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/20/2021
    Labeler - Walgreens Company (008965063)
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