Label: HONGO KILLER- undecylenic acid spray

  • NDC Code(s): 58593-601-15
  • 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 August 3, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient                 Purpose

    Undecylenic Acid 20% w/v.......... Antifungal

  • PURPOSE

    Purpose: Antifungal

  • 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
  • WARNINGS

    For external use only.

    Flammable: Keep away from fire and flame

    When using this product

    • avoid contact with the eyes and mucous membrane.
  • DO NOT USE

    Stop use and consult a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    Do not use

    • on children under 2 years of age unless directed by a doctor.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the 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.
    • Apply a thin layer of Hongo Killer Antifungal Spray 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 and nails.

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or Comments?

    (305) 805-3456 Monday-Friday (9 am - 5 pm EST).

    www.efficientlabs.com

  • PRINCIPAL DISPLAY PANEL

    HKSpray1.5

  • INGREDIENTS AND APPEARANCE
    HONGO KILLER 
    undecylenic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID2 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-601-151 in 1 BOX07/01/2013
    144 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/01/2013
    Labeler - Efficient Laboratories Inc (969044932)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNV, LLC118917568manufacture(58593-601)
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