Label: DERMAN ANTIFUNGAL- tolnaftate aerosol

  • NDC Code(s): 81929-006-01
  • Packager: Taisho Pharmaceutical California Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 30, 2024

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

    Purpose

    Antifungal

  • Uses

    • Clinically proven to prevent most athlete’s foot. 
    • prevent the recurrence of 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 container. Do not store at temperature above 120ºF. Keep out of the reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the 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 four 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 of the product 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, clean with a pin
  • Other information

    store between 20° and 30°C (68° and 86°F)

  • Inactive ingredients

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

  • Package Labeling:

    bottle

  • INGREDIENTS AND APPEARANCE
    DERMAN ANTIFUNGAL 
    tolnaftate aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81929-006
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOBUTANE (UNII: BXR49TP611)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81929-006-01150 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/01/2024
    Labeler - Taisho Pharmaceutical California Inc. (603827635)