Label: DERMAN ANTIFUNGAL POWDER TOLNAFTATE- tolnaftate aerosol, powder

  • NDC Code(s): 81929-001-01
  • Packager: Taisho Pharmaceutical California Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

    Purpose

    Antifungal

  • Uses

    Proven clinically effective in the treatment of most:

    Clinically proven to prevent most athlete's foot with daily use Relieves

    • Athlete's foot (tinea pedis) 
    • Jock itch (tine cruris)
    • Ringworm (tinea corporis)
    • itching 
    • cracking
    • burning
    • scaling
  • Warnings

    For external use only

     Contents under pressure. Do not puncture or incinetare or store at a temperature above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or white smoking. Flammable:

    Do not use 

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

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor 

    if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

    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
    • apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
    • supervise children in the use of this product
    • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch
    • to prevent most athlete's foot apply once or twice daily (morning and/or night)
    • if condition persists longer, consult a doctor 
    • this product is not effective on the scalp or nails
    • 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
  • Other information

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

  • Inactive ingredients

    BHT, Corn Starch, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    DERMAN ANTIFUNGAL POWDER TOLNAFTATE 
    tolnaftate aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81929-001
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ISOBUTANE (UNII: BXR49TP611)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81929-001-011 in 1 BOX05/01/2022
    1130 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00505/01/2022
    Labeler - Taisho Pharmaceutical California Inc. (603827635)