Label: HONGO KILLER- tolnaftate cream

  • NDC Code(s): 58593-286-01, 58593-286-05, 58593-286-10, 58593-286-22
  • Packager: Efficient Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    proven clinically effective in the treatment of most:

    • athlete's foot (tinea pedis)
    • ringworm (tinea corporis)
    • effectively soothes are relieves:
    • itching
    • burning
    • cracking
    • helps prevent most athlete's foot with daily use
  • Warnings

    For external use only.

    Do not use on children under 2 years of age unless directed by a doctor

    For Diaper Rash

    When using this product

    When using this product avoid contact with eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    Keep out of reach of children. If swallowed, get medical help or, contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • clean the affected area and dry thoroughly
    • 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
    • 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; for jock itch, use daily for 2 weeks. If condition persists, consult a doctor
    • to prevent athlete's foot, wash the feet, and dry thoroughly. Apply a thin layer over the affected area twice daily (morning and/or night)
    • this product is not effective on scalp or nails
  • Other information

    • store at 15°to 30°C (59°to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
  • Inactive ingredients

    ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

  • Questions or comments?

    Please call 305-805-3456
    (M-F 9:00 am-5:00 pm EST www.efficientlabs.com

  • SPL UNCLASSIFIED SECTION

    Distributed by Efficient Laboratories, Inc.,
    Miami, FL 33166 USA

  • PRINCIPAL DISPLAY PANEL -

    labellabellabel

  • INGREDIENTS AND APPEARANCE
    HONGO KILLER 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-286
    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
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    CETETH-20 (UNII: I835H2IHHX)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-286-051 in 1 CARTON01/01/2000
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58593-286-101 g in 1 PACKET; Type 0: Not a Combination Product01/01/2000
    3NDC:58593-286-011 in 1 CARTON01/01/2000
    328 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:58593-286-2228 g in 1 TUBE; Type 1: Convenience Kit of Co-Package01/01/201008/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/01/2000
    Labeler - Efficient Laboratories Inc (969044932)
    Registrant - Efficient Laboratories Inc (969044932)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex, LLC062808196manufacture(58593-286)
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