Label: KOSETTE CARE HAND SANITIZER ALCOHOL-FREE- benzalkonium chloride 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 July 1, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.11%

  • Purpose

    Antimicrobial

  • Uses

    • To decrease bacteria on skin when soap and water is not available.
    • Recommended for repeated use.
  • Warnings

    • For external use only.

    • When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water.

    • Stop use and ask a doctor if skin irritation or redness develops and lasts.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Place enough product in your palm to thoroughly cover your hands. Rub hands together until dry.
    • Children under 6 years should be supervised when using this product.
  • Other information

    • Read the directions and warnings before use.
    • Store in a cool, dry and well-ventilated place.
  • Inactive ingredients

    water(aqua), butylene glycol, propanediol, acrylates/c10-30 alkyl acrylate crosspolymer, caprylhydroxamic acid, caprylyl glyceryl ether, polyglyceryl-4 caprate, polyglyceryl-6 caprylate, potassium hydroxide, maltodextrin, moringa oleifera seed extract, frangrance(parfum)

  • Package Label - Principal Display Panel

    Kosette

    CARE

    HAND SANITIZER

    KILLS 99.9% OF GERMS

    ALCOHOL-FREE

    Safe for all, our gentle formula

    effectively disinfects hands while

    retaining skin's natural moisture

    leaving it soft and smooth.

    2.2 fl.oz / 65 ml

    Kosette Care Hand Sanitizer 65ml

  • INGREDIENTS AND APPEARANCE
    KOSETTE CARE HAND SANITIZER ALCOHOL-FREE 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73284-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0011 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ)  
    POLYGLYCERIN-6 (UNII: M51422LRAM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73284-420-5765 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - Innovation Labs, Inc. (117109069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Innovation Labs, Inc.117109069manufacture(73284-420)
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