Label: TOLNAFTATE- antifungal liquid spray aerosol, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 February 19, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • prevents recurrence of athlete's foot with daily use
    • for effective relief of itching, cracking and burning
  • ​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. Intentional misuse by deliberately concentrating and inhaling contents cans 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 4 weeks

    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 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 conditions persist, consult 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
  • ​Other information

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

  • ​Inactive ingredients

    BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B(36%w/w)

  • Questions?

    call 1-888-423-0139

  • ​Principal Display Panel

    TopCare

    health
    MEDICATED
    Athlete's

    Foot
    Liquid Spray

    TOLNAFTATE 1% • ANTIFUNGAL

    • Cures Most Athlete's Foot

    & Prevents Recurrences

    • Relieves Itching, Cracking & Burning

    NET WT 5.3 OZ (150 g)

    tolnaftate liquid spray

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    antifungal liquid spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.5 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOBUTANE (UNII: BXR49TP611)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-006-53150 g in 1 CAN; Type 0: Not a Combination Product01/03/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/03/2012
    Labeler - Topco Associates LLC (006935977)