Label: ANTIFUNGAL LIQUID- tolnaftate aerosol, spray

  • NDC Code(s): 63941-564-01
  • Packager: VALU MERCHANDISERS, CO
  • 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 14, 2023

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • prevents 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 4 weeks for athlete's foot and ringworm

    Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 4 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 a 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 20º and 30ºC (68º and 86ºF)

  • Inactive ingredients

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

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    soothing

    antifungal

    liquid spray

    tolnaftate 1%

    cures and prevents most

    athlete's foot

    relieves itching, cracking

    and burning

    NET WT 5.3 OZ (150 g)

    Image 1

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL LIQUID 
    tolnaftate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-564
    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)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    ISOBUTANE (UNII: BXR49TP611)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-564-01150 g in 1 CANISTER; Type 0: Not a Combination Product03/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/20/2021
    Labeler - VALU MERCHANDISERS, CO (868703513)
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