Label: TOLNAFTATE- antifungal powder spray aerosol, powder

  • 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 December 19, 2017

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  • Active ingredient

    Tolnaftate 1%

  • ​ ​Purpose

    Antifungal

  • Uses

    • Cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
    • If used daily, can prevent recurrence of athlete's foot
    • Relieves symptoms of athlete's foot, including itching, burning, and cracking
  • ​Warnings

    For external use only.

    Flammable:

    Do not use near heat or flame, or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

    ​When using this product

    • Do not get into eyes or mouth
    • Use only as directed
    • Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    ​Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

    ​Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

  • ​Directions

    • Wash affected area and dry thoroughly
    • Shake can well and 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • Use daily for 4 weeks for athletes foot, ringworm; use daily for 2 weeks for jock itch
    • If conditions persist, consult a doctor
    • To prevent athlete's foot, apply daily (morning and night)
    • This product is not effective on the scalps or nails
    • In case of clogging, clear nozzle under running water
  • ​Other information

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

  • Inactive ingredient

    BHT, isobutane (propellent), PPG-12-buteth-16, SD alcohol 40-B (14%w/w), talc

  • Questions or Suggestions?

    1.855.763.8733 or www.thepodiatreecompany.com. Our commitment to you is 100%

    satisfaction. If you are not completely satisf ied, please contact us directly for a full refund.

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    antifungal powder spray aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-913
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 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:54633-913-04130 g in 1 CANISTER; Type 0: Not a Combination Product07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/01/2013
    Labeler - The Podiatree Company (078656000)
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