Label: E2 SANITIZING HAND soap

  • NDC Code(s): 50865-017-03, 50865-017-07, 50865-017-09, 50865-017-41, view more
    50865-017-65, 50865-017-67
  • 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 24, 2023

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  • Active Ingredient

    Benzalkonium Chloride 0.13% w/w

  • Purpose

    Antibacterial Agent

  • Uses

    For handwashing to help reduce bacteria on the skin that could cause disease.

  • 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. If swallowed, contact a physician or poison control center.

  • Directions

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

  • Inactive Ingredients

    Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Hydroxyethyl Cellulose, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

  • QUESTIONS

    Kutol Product Co.
    Cincinnati, OH 45241
    www.Kutol.com

  • 1703 label

    1703 label

  • 1707 label

    1707 label

  • 1709 label

    1709 label

  • 1765 label

    1765 label

  • 1767 label

    1767 label

  • INGREDIENTS AND APPEARANCE
    E2 SANITIZING HAND 
    e2 sanitizing hand soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-017
    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)  
    HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50865-017-03209000 mL in 1 DRUM; Type 0: Not a Combination Product09/15/2015
    2NDC:50865-017-074000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2015
    3NDC:50865-017-094000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2015
    4NDC:50865-017-65800 mL in 1 BAG; Type 0: Not a Combination Product09/15/2015
    5NDC:50865-017-672000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2015
    6NDC:50865-017-411000 mL in 1 BAG; Type 0: Not a Combination Product09/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2015
    Labeler - KUTOL PRODUCTS COMPANY (004236139)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture(50865-017)
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