Label: E2 ANTIBACTERIAL FOAMING SKIN CLEANSER- benzalkonium chloride soap

  • NDC Code(s): 65601-817-03, 65601-817-04, 65601-817-29
  • 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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  • E2 Antibacterial Foaming Skin Cleanser

    ​Active Ingredient

    Benzalkonium Chloride 0.13%

  • E2 Antibacterial Foaming Skin Cleanser

    Uses

    • For handwashing to decrease the bacteria on the skin.
    • Recommended for repeated use.
  • E2 Antibacterial Foaming Skin Cleanser

    Warnings

    • For external use only.
    • When using this product avoid contact with eyes. In case of contact flush with water
    • Discontinue use is irritation or redness develops.
    • Stop use and ask a doctor If irritation persists for more than 72 hours, or if condition persists for more than 72 hours.
    • KEEP OUT OF REACH OF CHILDREN.
    • If swallowed, get medical help or contact Poison Control Center right away.
  • E2 Antibacterial Foaming Skin Cleanser

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 2 pumps of product in hands and scrub thoroughly over all surfaces of both hands for 15 seconds. Rinse with clean water.
  • E2 Antibacterial Foaming Skin Cleanser

    Inactive Ingredients

    ​Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid.

  • E2 Antibacterial Foaming Skin Cleanser

    Purpose

    Antimicrobial

  • E2 Antibacterial Foaming Skin Cleanser

    KEEP OUT OF REACH OF CHILDREN

  • E2 Antibacterial Foaming Skin Cleanser

    0429

  • INGREDIENTS AND APPEARANCE
    E2 ANTIBACTERIAL FOAMING SKIN CLEANSER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-817
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-817-043780 mL in 1 JUG; Type 0: Not a Combination Product01/17/2014
    2NDC:65601-817-291000 mL in 1 BAG; Type 0: Not a Combination Product01/17/2014
    3NDC:65601-817-03750 mL in 1 BOTTLE; Type 0: Not a Combination Product01/17/201409/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/17/2014
    Labeler - Betco Corporation, Ltd. (024492831)
    Registrant - Betco corporation, Ltd. (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.005050158manufacture(65601-817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corportation, Ltd.024492831label(65601-817) , pack(65601-817) , manufacture(65601-817)
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