Label: HONGO KILLER- undecylenic acid liquid

  • NDC Code(s): 58593-826-01
  • 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 2, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient                                   Purpose

    Undecylenic Acid 25% w/v ............................. Antifungal

  • PURPOSE

    Purpose

    Antifungal

  • WARNINGS

    Warnings

    For external use only

    Flammable: Keep away from fire or flame.

    When using this product:avoid with eyes or mucous membrane.

    Stop use and ask a doctor if:


    • irritation occurs
    • there is no improvement within 4 weeks
  • DO NOT USE

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

  • 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,consult a health care professional before using this product.

  • DOSAGE & ADMINISTRATION

    Directions
    Clean the affected area and dry thoroughly.

    • Apply a thin layer of Hongo Killer Antifungal Solution over 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 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. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
  • INDICATIONS & USAGE

    Uses
    For the cure of most:

    • athlete's foot (tinea pedis)
    • ringworm (tinea corporis)

    For the relief of:

    • itching
    • burning
    • scaling
    • cracking
    • soreness
    • irritation
  • QUESTIONS

    Questions or comments?
    305-805-3456 (M-F 9:00 am-5:00 pm EST) www.efficientlabs.com

  • INACTIVE INGREDIENT

    Inactive ingredients
    aloe, fragrance, hypromelloses, isopropyl alcohol, tocopherol acetate (Vitamin E), water

  • PRINCIPAL DISPLAY PANEL

    Solution

  • INGREDIENTS AND APPEARANCE
    HONGO KILLER 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-826
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-826-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product07/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/01/2012
    Labeler - Efficient Laboratories Inc (969044932)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc.007392322manufacture(58593-826)
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