Label: TOLNAFATE- tolnaftate jock itch powder spray - talc free aerosol, spray

  • NDC Code(s): 68016-653-46
  • Packager: Chain Drug Consortium, LLC
  • 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 January 25, 2023

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • cures most jock itch (tinea cruis)
    • relieves itching, burning and crafing associated with jock itch
  • 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

    When using this product

    • do not get into eyes or mouth, if products get into eyes, rinse eyes thoroughly with water
    • use only as directed

    Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

    Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 2 weeks

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. 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 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 86ºF)

  • 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

    Premier Value

    Antifungal

    Jock Itch Powder Spray

    Tolnaftate 1%

    Cures most jock itch

    Relieves itching, chafing and burning Premier Value Tolnaftate Jock Itch Powder Spray Talc Free

    Talc- Free

    NET WT 4.6 OZ (130 g)

  • INGREDIENTS AND APPEARANCE
    TOLNAFATE 
    tolnaftate jock itch powder spray - talc free aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-653
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.3 g  in 130 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:68016-653-46130 g in 1 CAN; Type 0: Not a Combination Product10/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/31/2017
    Labeler - Chain Drug Consortium, LLC (101668460)
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