Label: 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 March 24, 2022

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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • 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

    • irritation or redness develops
    • condition persists for more than 72 hours
  • Keep out of reach of children.

    If swallowed, get medical help 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, diglycerol, disodium cocoamphodiacetate, fragrance, glycerin, hydrochloric acid, methoxy PEG/PPG-7/3 aminopropyl dimethicone, methylchloroisothiazolinone, methylisothiazolinone, tetrasodium EDTA, water

  • SPL UNCLASSIFIED SECTION

    Distributed by:  S.P. Richards Company, Smyrna, GA 30082

    www.genuinejoe.com

  • principal display panel

    Genuine Joe

    FOAMING HAND SANITIZER

    Alcohol free

    14467

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62832-118
    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)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62832-118-05207 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/03/2017
    Labeler - S.P. Richards Company (007976384)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(62832-118)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(62832-118)
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