Label: ENMOTION FOAM- benzalkonium chloride solution

  • NDC Code(s): 54622-146-01
  • Packager: Georgia Pacific Consumer 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 February 25, 2022

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  • Active ingredient

    Benzalkonium Chloride 0.1%w/w

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on skin that could cause disease

    Recommended for repeated use

  • Warnings

    For external use only

  • When using this product

    do not use in or near eyes.

  • Discontinue use

    if irritation or redness develops.  If condition persists for more than 72 hours consult a doctor.

  • Keep out of reach of children.

    If swallowed, seek immediate medical attention or call a poison control center.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Inactive ingredients

    Water, Decyl Glycoside, PEG-12 Dimethicone, Glycerin, Dipotassium Phosphate, Potassium Phosphate

  • SPL UNCLASSIFIED SECTION

    PACIFIC BLUE ULTRA

    Foam Hand Sanitizer

    Alcohol Free

    Fragrance Free SKU 43338

    Manufactured for

    Georgia-Pacific Consumer Products LP.  Atlanta, GA 30303

    Questions? Call 1-866 HELLOGP (435-5647

    or visit us on line at www.gppro.com

    2017 Georgia-pacific Consumer Products LP. All rights reserved

    43338-V1PRDRevA

    146.000/146AA

  • principal display panel

    Foam Hand Sanitizer

    Alcohol Free

    1000 mL (33.8 FL OZ)

    4338V2PRDRevA17

    image description

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  • INGREDIENTS AND APPEARANCE
    ENMOTION FOAM 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54622-146
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.998 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54622-146-011000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2016
    Labeler - Georgia Pacific Consumer Products (806142217)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(54622-146)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(54622-146)
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