Label: HONGO KILLER- tolnaftate aerosol, powder

  • NDC Code(s): 58593-285-04
  • Packager: Efficient Laboratories 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 December 1, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredients:             Purpose

    Tolnaftate 1% W/W........................ Antifungal


  • PURPOSE

    Purpose: Antifungal

  • INDICATIONS & USAGE

    Uses 

    Proven clinically effective in the treatment of most:

    • athlete's foot (tinea pedis)
    • jock itch (tinea cruris)
    • ringworm (tinea corporis)

    Clinically proven to prevent most athlete's foot with dauly use

    Relieves 

    • itching
    • cracking
    • burning
    • scaling
    • discomfort
  • WARNINGS


    Warnings

    For external use only

    Flammable:Contents under pressure. Do not puncture or incinerate or store at a temperature above 120 degrees F. Use only as directed. intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or while smoking.


  • DO NOT USE

    Do not use on children under 2 years of age


    When using this product avoid contact with eyes

    Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • clean the affected area and dry thoroughly
    • shake can well before use: Hold can about 6 inches from the area to be treated.
    • apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
    • supervise children in the use of this product

    Athlete's Foot and Ringworm - use daily for 4 weeks

    Jock Itch - use daily for 2 weeks

    • to prevent most athlete's foot, apply once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails

    For athlete's foot:

    • pay special attention to the spaces between the toes
    • wear well-fitting, ventilated shoes, and change shoes and socks at least once a day
  • QUESTIONS

    Questions or comments?


    Please Call 305-805-3456 (M-F 9:00-5:00 pm EST)

  • INACTIVE INGREDIENT

    Inactive ingredients Alcohol SD-40-B (14% w/w), BHT, PPG-12-Buteth-16, Kaolin, Zea Mays (Corn) Starch, Isobutane

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HONGO KILLER 
    tolnaftate aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-285
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.1 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOBUTANE (UNII: BXR49TP611)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-285-04130 g in 1 CANISTER; Type 0: Not a Combination Product03/01/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/01/2002
    Labeler - Efficient Laboratories Inc (969044932)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Spraytech, LLC137135237manufacture(58593-285)