Label: GP PBU ANTIMICROBIAL FOAM- benzalkonium chloride solution

  • NDC Code(s): 54622-313-01
  • Packager: Georgia Pacific Consumer Products
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 2, 2024

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride, 0.13%

  • Purpose

    Antiseptic

  • Use

    Handwash to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only

    When using this product

    Avoid contact with the eyes. In case of eye contact, flush with water.

    Stop use

    if irritation or redness developes. 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, apply soap, rub hands togetehr vigorously for at least 20 seconds.

    Rinse and dry hands thoroughly.

  • Inactive ingredients

    Water (Aqua), Lauramine Oxide, Lauryl Betaine, Glycerin, Laurtrimonium Chloride, Sodium PCA, Tocopheryl Acetate, Oleth-10, Tetrasodium EDTA, Citric Acid, Red 40, Yellow 6, Fragrance

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    GP PBU ANTIMICROBIAL FOAM 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54622-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    LAURYL BETAINE (UNII: Y4P927Q133)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    OLETH-10 (UNII: JD797EF70J)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54622-313-011200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/05/2021
    Labeler - Georgia Pacific Consumer Products (806142217)
    Registrant - Cyan Labs S.A. de C.V. (812754130)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cyan Labs S.A. de C.V.812754130manufacture(54622-313) , analysis(54622-313) , label(54622-313) , pack(54622-313)
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