Label: HONGO KILLER NAIL AND FUNGUS- undecylenic acid kit

  • 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 February 15, 2020

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

  • Active Ingredients

    Undecylenic Acid 25%

  • Purpose

    Antifungal

  • 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 or flame.

    When using this product: avoid contact with eyes or mucous membranes.

    Stop use and ask doctor if:

    • irritation occurs
    • there is no improvement within 4 weeks

    Do not use on children under 2 years of age

  • Pregnancy or Breast Feeding

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

  • 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.

  • 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 scalp or nails.
  • Questions

    Questions or comments?

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

  • Inactive ingredients

    aloe vera, fragrance, hydroxypropyl methylcellulose, isopropyl alcohol (70% v/v), water, Vitamin E

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HONGO KILLER  NAIL AND FUNGUS
    undecylenic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-301
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-301-601 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package07/01/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, WITH APPLICATOR 30 mL
    Part 21 PACKAGE 30 mL
    Part 1 of 2
    HONGO KILLER 
    undecylenic acid liquid
    Product Information
    Item Code (Source)NDC:58593-300
    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)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-300-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C
    Part 2 of 2
    HONGO KILLER NAIL 
    nail creams and lotions
    Product Information
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 PACKAGE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333c07/01/2016
    Labeler - EFFICIENT LABORATORIES INC (969044932)