Label: CLEANHANDS- benzalkonium chloride soap

  • NDC Code(s): 73788-103-01
  • Packager: Hangzhou Huiji Biotechnology Co., Ltd.
  • 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 February 24, 2022

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Use

    For hand sanitizing to reduce bacteria
    on the skin.

  • WARNINGS

    For external use only
    When using this product avoid contact with eyes.
    In case of eye contact, flush with water.
    Stop use and ask a doctor if irritation or 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.

  • Directions

    ●Pump into hands, wet as needed.
    ●Lather vigorously for at least 15 seconds.
    ●Wash skin, rinse thoroughly and dry.

  • Inactive ingredients

    water, cetrimonium
    chloride, glycerin, lauramidopropylamine oxide, cocamide
    MEA, sodium chloride, PEG-120 methyl glucose dioleate,
    citric acid, tetrasodium EDTA, methylchloroisothiazolinone,
    methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    CLEANHANDS 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73788-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73788-103-0120 in 1 CARTON07/15/2020
    1500 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/15/2020
    Labeler - Hangzhou Huiji Biotechnology Co., Ltd. (526893497)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Huiji Biotechnology Co., Ltd.526893497manufacture(73788-103)
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