Label: E2 HAND SANITIZER solution

  • NDC Code(s): 64542-017-03, 64542-017-09, 64542-017-41, 64542-017-46, view more
    64542-017-94
  • Packager: State Industrial Products
  • 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 24, 2023

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  • DOSAGE & ADMINISTRATION

    Directions To decrease bacteria on skin, apply a small amount covering hands with product for 30 seconds. Add water, lather and rinse.

  • ACTIVE INGREDIENT

    Active Ingredient 0.13% Benzalkonium Chloride

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocammidopropyl Betaine, PEG-6 Cocamide, Hydroxyethylcellulose, Laurtrimonium Chloride, Iodopropynl Butylcarbamate, Methylisothiazolinone

  • PURPOSE

    Purpose Antibacterial Agent

  • WARNINGS

    Warnings For external use only. Avoid contact with eyes. If contact occurs, flush with water. Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    State Label

  • INGREDIENTS AND APPEARANCE
    E2 HAND SANITIZER 
    e2 hand sanitizer solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64542-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64542-017-411000 mL in 1 BAG; Type 0: Not a Combination Product02/07/2018
    2NDC:64542-017-093785 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2018
    3NDC:64542-017-943000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2018
    4NDC:64542-017-46675 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/07/2018
    5NDC:64542-017-03208197 mL in 1 DRUM; Type 0: Not a Combination Product02/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/07/2018
    Labeler - State Industrial Products (004520987)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(64542-017)
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