Label: LHS108- antibacterial hand wash liquid

  • 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 28, 2020

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  • active ingredient

    Benzalkonium Chloride

  • purpose

    Antibacterial

  • INDICATIONS & USAGE

    Avoid contact with the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

  • WARNINGS

    For external use only - Hands only.

  • WHEN USING

    Avoid contact with the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develops.

  • 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.

  • DOSAGE & ADMINISTRATION

    Wash hands and rinse.

  • INACTIVE INGREDIENT

    water, acrylates copolymer, glycerin, aminomethyl propanol, hydroxypropyl methylcellulose, fragrance

  • LHS108 Product Labels

    263.59 ml: NDC Code 77093-400-01 263.59 ml label

    473.18 ml: NDC Code 77093-400-02 473.18 ml label

    3785ml : NDC Code 77093-400-03 3785 ml label

  • INGREDIENTS AND APPEARANCE
    LHS108 
    antibacterial hand wash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77093-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77093-400-02473.18 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/28/2020
    2NDC:77093-400-01236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/28/2020
    3NDC:77093-400-033785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/28/2020
    Labeler - Vincit Zee Company (097763525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vincit Zee Company097763525manufacture(77093-400)
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