Label: INDUSTRIAL FOAMING HAND SANITIZER- benzalkonium chloride aerosol, foam

  • 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 December 4, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

    • For hand sanitizing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only

    When using this product avoid contact with eyes. If contact with eyes, flush 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

    • Pump a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together briskly until dry.
  • Inactive Ingredients

    DI Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

  • Questions or Comments

    Call (480) 443-9255

  • PRINCIPAL DISPLAY PANEL - 591 ML Bottle Label

    STRENGTH

    INDUSTRIAL
    FOAMING SANITIZER

    KILLS GERMS

    20 FL. OZ. (591ML) e

    Principal Display Panel - 591 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    INDUSTRIAL FOAMING HAND SANITIZER 
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-402
    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)  
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Laurtrimonium Chloride (UNII: A81MSI0FIC)  
    Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5)  
    Glycereth-17 Cocoate (UNII: 3057VPT0KC)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-402-12591 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59555-402-113785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:59555-402-1350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A12/21/2015
    Labeler - R & R Lotion, Inc (062979000)
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