Label: FOAMING HAND- benzalkonium chloride lotion

  • NDC Code(s): 75447-224-96
  • Packager: OptiSource International, Inc
  • 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 April 26, 2022

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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    • to decrease bacteria on the skin that could cause disease
  • Warnings

    for external use only: hands

  • When using this product

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

    • irritation or 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 immediately.

  • 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

    water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, citric acid, tetrasodium EDTA, sodium benzoate

  • Rear label text

    Distributed by:

    OptiSource International, Inc

    40 Sawgrass Drive, Bellport, NY 11713

  • principal display panel

    Optical

    Soap

    • Hypoallergenic
    • Antibacterial
    • Fragrance Free

    Sanitizing Foaming Hand Soap

    7.5 FL OZ (221 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75447-224
    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
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75447-224-96222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - OptiSource International, Inc (849200159)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(75447-224)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(75447-224)
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