Label: DEFENDER ANTISEPTIC FOAM HAND - benzalkonium chloride soap 

  • Label RSS
  • NDC Code(s): 42953-000-00, 42953-000-01
  • Packager: Scientific Molecular Technologies
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

If you are a consumer or patient please visit this version.

  • Drug Facts
  • Active Ingredients

    Benzalkonium Chloride 0.13%

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  • Purpose

    Antimicrobial

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  • Uses

    • For hand washing to decrease bacteria on the skin.
    • Recommended for repeated use.
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  • 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

    irritation or redness develops.  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.

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  • Directions

    • Pump a small amount of foam into palm of hand.
    • Run thoroughly over all surfaces of both hands for 15 seconds
    • Rinse with potable water.
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  • Inactive Ingredients

    Water, (aqua), butylene glycol,  Dihydroxypropyl PEG-5 linoleammonium chloride, Dihydroxyethyl cocamine oxide, glycereth-2 cocoate, Hydroxypropyl methylcellulose.

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  • PRINCIPAL DISPLAY PANEL

    DE Fender  SCIENTIFIC MOLECULAR TECHNOLOGIES    ANTISEPTIC FOAM  Hand Soap    ELIMINATES 99.999% OF MOST COMMON GERMS THAT CAUSES ILLNESS   NO RINSE MOISTURIZES LEAVES SKIN SOFT  8.4 fl oz (250 ml)

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  • Product Label
  • INGREDIENTS AND APPEARANCE
    DEFENDER ANTISEPTIC FOAM HAND 
    benzalkonium chloride soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42953-000
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    BUTYLENE GLYCOL  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE  
    DIHYDROXYETHYL COCAMINE OXIDE  
    GLYCERETH-2 COCOATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42953-000-00 250 mL in 1 BOTTLE, PUMP
    2 NDC:42953-000-01 1000 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333E 10/11/2012
    Labeler - Scientific Molecular Technologies (028159474)
    Establishment
    Name Address ID/FEI Business Operations
    Artemis Bio-Solutions Inc. 963442541 manufacture(42953-000)
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