Label: SANISUDS FOAM HAND SANITIZER- benzalkonium chloride soap 

  • NDC Code(s): 48417-750-02
  • Packager: Palmer Fixture Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 03/14

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

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  • Purpose

    Antimicrobial

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  • Uses

    • For hand sanitizing 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 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.

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  • 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.
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  • Inactive Ingredients

    Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance

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  • INGREDIENTS AND APPEARANCE
    SANISUDS FOAM HAND SANITIZER 
    benzalkonium chloride soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:48417-750
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride 1.00 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CETRIMONIUM CHLORIDE  
    LAURTRIMONIUM CHLORIDE  
    DIHYDROXYETHYL COCAMINE OXIDE  
    CITRIC ACID MONOHYDRATE  
    GLYCERETH-17 COCOATE  
    Product Characteristics
    Color white (water white - colorless, dispensed as a white foam) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48417-750-02 3 in 1 BOX
    1 1200 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 04/07/2009
    Labeler - Palmer Fixture Company (185454241)
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