Label: PACIFIC BLUE ULTRA ANTIMICROBIAL FOAM FRAGRANCE FREE- benzalkonium chloride solution

  • NDC Code(s): 54622-316-01, 54622-316-02
  • Packager: Georgia-Pacific Consumer Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 2, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium chloride, 0.13% w/w

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

    Stop use

    if irritation or redness develops. 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 together vigorously for at least 20 seconds.

    Rinse and dry hands thoroughly with a disposable paper towel.

  • Inactive ingredients


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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PACIFIC BLUE ULTRA ANTIMICROBIAL FOAM FRAGRANCE FREE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54622-316
    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
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    OLETH-10 (UNII: JD797EF70J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL BETAINE (UNII: Y4P927Q133)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SODIUM PIDOLATE (UNII: 1V74VH163T)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54622-316-014 in 1 BOX06/14/2023
    11200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:54622-316-023 in 1 BOX06/14/2023
    21200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/14/2023
    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(54622-316) , analysis(54622-316) , label(54622-316) , pack(54622-316)
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