Label: FOAMY BLUE- benzalkonium chloride solution

  • NDC Code(s): 65585-526-01, 65585-526-02
  • Packager: Whisk Products, 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 February 10, 2023

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Skin Antimicrobial

  • Use

    reduces amount of bacteria on hands

  • Warnings

    For external use only.

    When using this product avoid contact with eyes.  In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply a palmful to hands and forearms.
    • Scrub thoroughly for at least fifteen seconds.
    • Rinse completely and dry.
  • Inactive Ingredients

    Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Fragrance, Blue 1

  • PRINCIPAL DISPLAY PANEL

    1000 mL Bag Label

  • INGREDIENTS AND APPEARANCE
    FOAMY BLUE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-526
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (dispensed as a light blue foam) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-526-01800 mL in 1 BAG; Type 0: Not a Combination Product01/18/202301/18/2023
    2NDC:65585-526-021000 mL in 1 BAG; Type 0: Not a Combination Product01/18/202301/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/18/202301/31/2025
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-526)
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