Label: BIOCENTRIS E2 HANDWASH- benzalkonium chloride liquid

  • 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 June 30, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium chloride 0.13% w/w

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • Handwash to help reduce bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.
  • WARNINGS

    Warnings

    For external use only.

    When using this product keep away from eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • DOSAGE & ADMINISTRATION

    Directions

    • Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds
    • Rinse with water and towel dry.
  • INACTIVE INGREDIENT

    Inactive ingredients Water, Ethanol, Cocamidopropyl PG-Dimonium Chloride Phosphate, Phenoxyethanol, Polyquatemium 11, Decyl Glucoside, Cetrimonium Chloride, Polyquatemium-10, Chlorhexidine Gluconate

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    biocentris PHARMACEUTICALS

    24 Executive Parkway, Ringwood, NJ 07456

    888-497-4375

    info@biocentris.com • www.biocentris.com

  • PRINCIPAL DISPLAY PANEL

    E2 FOAM HANDWASH FOR FOOD INDUSTRY PROFESSIONALS

    One Step Hand Wash & Sanitizer

    KILLS 99.99% of most germs

    NET CONTENTS: 33.8 FL. OZ. (1000 ML)

    81232-402 BioCentris E2-0622

  • INGREDIENTS AND APPEARANCE
    BIOCENTRIS E2 HANDWASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81232-402
    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
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81232-402-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    2NDC:81232-402-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    3NDC:81232-402-011000 mL in 1 POUCH; Type 0: Not a Combination Product04/20/2021
    4NDC:81232-402-17532 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2018
    Labeler - Biocentris Pharmaceuticals, LLC (015882747)
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