Label: FOAMING HAND SANITIZER- benzalkonium chloride lotion

  • NDC Code(s): 71897-118-45
  • Packager: VERITIV OPERATING 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 February 3, 2023

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Use

    to decrease bacteria on the skin

  • Warnings

    for external use only: hands only

  • When using this product

    • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.
    • avoid contact with broken skin
  • Stop use and ask a doctor if

    • if irritation and redness develop
    • condition persists for more than 72 hours
  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Inactive ingredients

    cetrimonium chloride, diglycerin, disodium cocoamphodiacetate, fragrance, glycerin, hydrochloric acid, methoxy PEG/PPG-7/3 aminopropyl dimethicone, sodium benzoate, tetrasodium EDTA, water

  • Rear label text

    Distributed by

    Veritiv Operating Company

    Atlanta, GA 30328

    reliablebrand.com

  • PRINCIPAL DISPLAY PANEL

    ALCOHOL FREE FOAM HAND SANITIZER

    Manual push style

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71897-118
    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
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DIGLYCERIN (UNII: 3YC120743U)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    METHOXY PEG/PPG-7/3 AMINOPROPYL DIMETHICONE (UNII: 4M7P1JZ2V2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71897-118-451000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/05/2020
    Labeler - VERITIV OPERATING COMPANY (006989982)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(71897-118)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(71897-118)
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