Label: GEL- antibacterial hand soap gel

  • 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 August 22, 2022

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  • ACTIVE INGREDIENT

    Alkyl Dimethyl Benzyl Ammonium Chloride 0.5%

  • PURPOSE

    For hand-washing to decrease bacteria on the skin. Rocommended for repeated use.

  • WARNINGS

    • For external use only: hands
    • Do not use if you are allergic to any of the ingedients listed below

    When using this product:

    • avoid contact with eyes. In case of eye contact, flush thoroughly with water

    Stop use and ask a doctor if:

    • irritation and redness develop

  • INDICATIONS & USAGE

    Directions:

    • Wet hands
    • Rinse well and dry hands completely
  • INACTIVE INGREDIENT

    Water, Sodium Olefin Sulfonate, Lauramine Oxide, Dimethyletradecylamine Oxide, Sodium Sulfonate, Cocamide DEA, Glycerin, Diethanolamine, Citric Acid, Fragrance, Dye

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    If swallowed, get medical help, or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Apply small amount of product and work into a lather

  • PRINCIPAL DISPLAY PANEL

    8oz label gallon label

  • INGREDIENTS AND APPEARANCE
    GEL 
    antibacterial hand soap gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75594-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 kg  in 1000 kg
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75594-190-080.227 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/22/2022
    2NDC:75594-190-283.63 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/22/2022
    Labeler - Commercial Beverage Concepts LLC (080925174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Commercial Beverage Concepts LLC080925174manufacture(75594-190) , label(75594-190) , pack(75594-190)
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