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
  • 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 August 18, 2023

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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 not finalpart333E10/01/2015
    Labeler - Kutol Products Company (004236139)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(50865-683)
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