Label: ALPHA E-2- benzalkonium chloride soap 

  • Label RSS
  • 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 01/13

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  • Active Ingredient

    Benzalkonium Chloride 2.5%

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  • Purpose

    Skin Sanitizer

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  • Use

    reduces amount of bacteria on hands

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  • Warnings

    Avoid contact with eyes. If contents come in contact with eyes, flush with water for at least 15 minutes and get medical attention.

    For external use only.

    If irritation develops, use of this product should be discontinued. If irritation persists for more than 72 hours, consult a physician.

    Do not allow concentrate to come in contact with food.

    For institutional and professional use only.

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  • Directions

    • Hands need not be washed prior to using.
    • Dispense a small amount into palm of hand.
    • Wash for at least 15 seconds.
    • Rinse with potable water.
    • Repeat as needed.
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  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, PEG-6 Cocamide, Hydroxypropyl Methylcellulose, Quaternium-15, Citric Acid, Sodium Hydroxide

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  • INGREDIENTS AND APPEARANCE
    ALPHA E-2 
    benzalkonium chloride soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65585-495
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    COCAMIDOPROPYL BETAINE  
    COCAMIDOPROPYLAMINE OXIDE  
    PEG-6 COCAMIDE  
    HYPROMELLOSES  
    QUATERNIUM-15  
    CITRIC ACID MONOHYDRATE  
    SODIUM HYDROXIDE  
    Product Characteristics
    Color yellow (very pale yellow - very pale gold) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65585-495-01 3785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 01/21/2008
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    Name Address ID/FEI Business Operations
    Whisk Products, Inc. 834270639 manufacture(65585-495)
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