Label: KLENLII HAND SANII ALCOHOL SANITIZER- ethyl alcohol gel

  • 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 January 17, 2022

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

  • PURPOSE

    ANTISEPTIC

  • USES

    • DECREASE BACTERIA ON SKIN THAT COULD CAUSE DISEASE
    • RECOMMENDED FOR REPEATED USE
  • WARNINGS

    FOR EXTERNAL USE ONLY: HANDS

    FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

    WHEN USING THIS PRODUCT

    • KEEP OUT OF EYES
    • IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER
    • AVOID CONTACT WITH BROKEN SKIN
    • DO NOT INHALE OR DIGEST

    STOP USE AND ASK DOCTOR IF

    • IRRITATION OR REDNESS DEVELOPS
    • CONDITION PERSISTS MORE THAN 72 HOURS
  • 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 THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING
    • NOT FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION
    • NOT RECOMMENDED FOR INFANTS

  • INACTIVE INGREDIENTS

    DEIONIZED WATER, CARBOPOL, GLYCERIN, FRAGRANCE

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Klenlii Hand Sanii Gel_8oz

  • INGREDIENTS AND APPEARANCE
    KLENLII HAND SANII ALCOHOL SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78016-102
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78016-102-18237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    2NDC:78016-102-14118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package05/27/2020
    3NDC:78016-102-16476 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    4NDC:78016-102-113785 mL in 1 JUG; Type 0: Not a Combination Product05/27/2020
    5NDC:78016-102-1259 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2020
    Labeler - Klenlii Company (117278596)
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