Label: FIRST DEPHENSE ALCOHOL-FREE ANTISEPTIC FOAM HAND SANITIZER- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 28, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

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

    Warnings

    • For external use only.

    • Do not use in eyes. If contact occurs, flush eyes with water.

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

    • 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 palm of hand.
    • Wet hands thoroughly with product and allow to dry without wiping.
    • Rub hands together briskly until dry.
  • INACTIVE INGREDIENT

    Inactive Ingredients

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

  • SPL UNCLASSIFIED SECTION

    Distributed by first depHense, LLC
    519 S. Main St., Sycamore, IL 60178

    Made in USA.

  • PRINCIPAL DISPLAY PANEL

    • NO RINSE
    • MOISTURIZES
    • LEAVES SKIN SOFT

    Up To 3 Times MORE APPLICATIONS
    THAN ALCOHOL-BASED GELS



    first depHense
    Protecting your health and environment

    ALCOHOL-FREE
    Antiseptic Foam Hand Sanitizer

    Eliminates 99.999%
    OF MOST COMMON GERMS THAT MAY CAUSE ILLNESS


    Environmentally  Friendly
    1.7 floz (50ml)

    HandSanitizer

  • INGREDIENTS AND APPEARANCE
    FIRST DEPHENSE ALCOHOL-FREE ANTISEPTIC FOAM HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76116-100
    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)  
    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:76116-100-0150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E01/13/2011
    Labeler - First Dephense, LLC (028165717)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Blending and Filling809226710manufacture
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