Label: NATIVE GREEN FOAMING HAND SANITIZER- benzalkonium chloride solution

  • 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 April 2, 2010

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  • Active Ingredient:

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

    • For hand sanitizing to decrease bacteria on the skin
  • Warning

    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

    • 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 Water, dihydroxpropyl PEG-5
    linoleammonium chloride, glycereth-2 cocoate, behentrimonium
    chloride, dihydroxyethyl cocamine oxide, fragrance

  • Principal Display Panel – Bottle Label

    NATIVE GREEN
    FOAMING HAND SANITIZER
    ALCOHOL-FREE – WITH MOISTURIZERS

    Cleaner, Greener

    SEE SIDE PANEL FOR ADDITIONAL INFORMATION.

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    NATIVE GREEN FOAMING HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50409-514
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    dihydroxypropyl peg-5 linoleammonium chloride (UNII: 0Y0NQR2GH1)  
    glycereth-2 cocoate (UNII: JWM00VS7HC)  
    behentrimonium chloride (UNII: X7GNG3S47T)  
    dihydroxyethyl cocamine oxide (UNII: 8AR51R3BL5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50409-514-82550 mL in 1 BOTTLE
    2NDC:50409-514-4250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33304/21/2010
    Labeler - Native Green (791610038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canberra Corporation068080621MANUFACTURE
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