Label: E3 ALCOHOL FREE FOAMING SANITIZER- benzalkonium chloride soap

  • NDC Code(s): 65601-779-03, 65601-779-04, 65601-779-05, 65601-779-29, view more
    65601-779-55
  • Packager: Betco Corporation, 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 September 11, 2020

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  • ACTIVE INGREDIENT

  • INDICATIONS & USAGE

  • WARNINGS

  • DOSAGE & ADMINISTRATION

  • INACTIVE INGREDIENT

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    045529

  • INGREDIENTS AND APPEARANCE
    E3 ALCOHOL FREE FOAMING SANITIZER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-779
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-779-043780 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    2NDC:65601-779-051200 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201607/15/2020
    3NDC:65601-779-03750 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201607/15/2020
    4NDC:65601-779-291000 mL in 1 BAG; Type 0: Not a Combination Product01/01/2016
    5NDC:65601-779-5520818 mL in 1 DRUM; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2016
    Labeler - Betco Corporation, Ltd. (024492831)
    Registrant - Betco Corporation, Ltd. (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.024492831manufacture(65601-779) , pack(65601-779) , label(65601-779) , analysis(65601-779)
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