E3 ALCOHOL FREE FOAMING SANITIZER (BENZALKONIUM CHLORIDE) SOAP [BETCO CORPORATION, LTD.]

E3 ALCOHOL FREE FOAMING SANITIZER (BENZALKONIUM CHLORIDE) SOAP [BETCO CORPORATION, LTD.]
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NDC 65601-779-03, 65601-779-04, 65601-779-05, 65601-779-29
Set ID 4c26cb1e-7032-423a-a669-f33c42f2dc86
Category HUMAN OTC DRUG LABEL
Packager Betco Corporation, Ltd.
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

  • INDICATIONS & USAGE

  • WARNINGS

  • DOSAGE & ADMINISTRATION

  • INACTIVE INGREDIENT

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    779.jpg

  • 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)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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 Product01/01/201603/26/2019
    2NDC:65601-779-051200 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    3NDC:65601-779-03750 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    4NDC:65601-779-291000 mL in 1 BAG; 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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