Label: TOLNAFATE- tolnaftate powder spray aerosol, spray

  • NDC Code(s): 79481-0623-1
  • Packager: Meijer Distribution Inc.
  • 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 August 30, 2023

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • cures most jock itch (tinea cruris)
    • relieves itching, burning, and chafing associated with jock itch
  • Warnings

    For external use only.

    Flammable:

    Do not use while smoking 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 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 2 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
    • use daily for 2 weeks; if conditions persist, consult a doctor
    • if nozzle clogs, clean with a pin
  • Other information

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

  • Inactive ingredients

    BHT, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B, Zea Mays (Corn) Starch

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    Meijer

    Antifungal

    Jock Itch

    Powder Spray

    Tolnaftate 1%/Antifungal

    • Cures most jock itch
    • Relieves itching & burning
    • Talc free

    NET WT. 4.6 OZ. (130g)

    image 1

  • INGREDIENTS AND APPEARANCE
    TOLNAFATE 
    tolnaftate powder spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0623
    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)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    ALCOHOL (UNII: 3K9958V90M)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0623-1130 g in 1 CAN; Type 0: Not a Combination Product08/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/18/2023
    Labeler - Meijer Distribution Inc. (006959555)
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