Label: ANTIBACTERIAL HAND MOUSSE- benzalkonium chloride liquid

  • 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 13, 2011

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    For handwashing to decrease bacteria on skin.

    Recommended for repeated use.

  • WARNINGS

    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 conditions 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Pump a small amount of foam into the palm of hand

    Rub thoroughly over all surfaces of both hands for 15 seconds

    Rinse with potable water.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide.

  • PRINCIPAL DISPLAY PANEL

    ANTIBACTERIAL

    HAND SOAP

    MOUSSE

    CLEANS IN SECONDS

    KILLS 99.9% of BACTERIA

    FREE from ALCOHOL

    CHLORINE, FRAGRANCE and DYES

    8.45fl oz

    (250ml)

    container label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND MOUSSE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76268-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76268-002-03250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/28/2011
    Labeler - ORGANICA (UK) LTD (235330151)
    Establishment
    NameAddressID/FEIBusiness Operations
    ORGANICA (UK) LTD235330151manufacture
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