Label: ANTIMICROBIAL LIQUID CITRUS- benzalkonium chloride soap

  • NDC Code(s): 22431-145-01, 22431-145-02
  • Packager: Blue Cross Laboratories, LLC
  • 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 January 10, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Benzalkonium Chloride 0.3% Antimicrobial

  • PURPOSE

    Uses

    Antimicrobial hand soap

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental Ingestion, seek medical attention or contact a poison control center immediately.

  • INDICATIONS & USAGE

    When using this product

    • do not use in or near eyes
  • WARNINGS

    Warnings

    For external use only

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands
    • dispense a small amount of soap into the palm of the hand
    • Work up a lather, adding water as needed
    • Rinse and dry thoroughly
  • INACTIVE INGREDIENT

    Inactive ingredients: Dodecylbenzenesulfonic Acid, Ninol 40-CO, Caustic Soda 50%, Sodium Laureth Sulfate, Fragrance, FD&C Red#40, FD&C Yellow #5

  • PRINCIPAL DISPLAY PANEL

    First Street

    Antimicrobial Liquid Soap Citrus Scented

    67.5 FL Oz (2L)

    Citrus Hand soap

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL LIQUID CITRUS 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-145-012000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/2019
    2NDC:22431-145-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/21/2019
    Labeler - Blue Cross Laboratories, LLC (118887378)
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