Label: KLENLII HAND ANTIBACTERIAL- chloroxylenol soap

  • NDC Code(s): 78016-104-11, 78016-104-12, 78016-104-14, 78016-104-16, view more
    78016-104-18
  • Packager: Klenlii Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 14, 2020

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  • ACTIVE INGREDIENT

    CHLOROXYLENOL 0.3%

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • HANDWASH TO HELP DECREASE BACTERIA ON THE SKIN
    • RECOMMENDED FOR REPEATED USE
  • WARNINGS

    FOR EXTERNAL USE ONLY: HANDS

    WHEN USING THIS PRODUCT

    • KEEP OUT OF AND AWAY FROM EYES
    • IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER
    • DO NOT INHALE OR INGEST

    STOP USE AND ASK DOCTOR IF

    • IRRITATION OR REDNESS DEVELOPS
    • CONDITION PERSISTS
  • 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

    • WET HANDS
    • APPLY A SMALL AMOUNT OF PRODUCT AND WORK INTO A LATHER
    • RINSE WELL AND DRY HANDS COMPLETELY

  • INACTIVE INGREDIENTS

    DEIONIZED WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, AQUEOUS CATONIC COPOLYMER, CITRIC ACID

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Klenlii_Hand Sanii Soap_8oz

  • INGREDIENTS AND APPEARANCE
    KLENLII HAND  ANTIBACTERIAL
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78016-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78016-104-18238 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2020
    2NDC:78016-104-14118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/14/2020
    3NDC:78016-104-16476 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2020
    4NDC:78016-104-113785 mL in 1 JUG; Type 0: Not a Combination Product06/14/2020
    5NDC:78016-104-1259 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/14/2020
    Labeler - Klenlii Company (117278596)
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