Label: FOAMING SANITIZING HAND- benzalkonium chloride soap

  • NDC Code(s): 50865-683-03, 50865-683-04, 50865-683-09, 50865-683-17, view more
    50865-683-41, 50865-683-44, 50865-683-78
  • Packager: Kutol Products Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.13% w/w

  • PURPOSE

    Purpose

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact a physician or poison control center. 

  • INDICATIONS & USAGE

    Uses For handwashing to decrease bacteria on skin

  • DOSAGE & ADMINISTRATION

    Directions Apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

  • WARNINGS

    Warnings

    For external use only. Do not use in the eyes. If eye contact occurs, flush eyes with water.

    Stop use and ask a doctor if redness and irritation occur and last for more than 72 hours.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water,  cocamidopropyl PG-dimonium chloride phosphate,cocamidopropyl betaine, PEG-6 cocamide, laurtrimonium chloride, iodopropynyl butylcarbamate,methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FOAMING SANITIZING HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-683
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.003 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50865-683-034000 mL in 1 DRUM; Type 0: Not a Combination Product10/01/201506/10/2017
    2NDC:50865-683-411000 mL in 1 BAG; Type 0: Not a Combination Product10/01/2015
    3NDC:50865-683-78950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/201506/10/2017
    4NDC:50865-683-441000 mL in 1 BAG; Type 0: Not a Combination Product06/12/2016
    5NDC:50865-683-1750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/12/2016
    6NDC:50865-683-041000 mL in 1 BAG; Type 0: Not a Combination Product06/12/2017
    7NDC:50865-683-091000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/201506/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/01/2015
    Labeler - Kutol Products Company (004236139)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(50865-683)
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