Label: ALPHA FOAMING E-2- benzalkonium chloride soap

  • NDC Code(s): 65585-510-01, 65585-510-02
  • Packager: Whisk Products, Inc.
  • 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

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

  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Close
  • Purpose

    Antimicrobial

    Close
  • Uses

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

    Close
  • Directions

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

    Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid, fragrance

    Close
  • INGREDIENTS AND APPEARANCE
    ALPHA FOAMING E-2 
    benzalkonium chloride soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65585-510
    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  
    COCO GLUCOSIDE  
    LAURTRIMONIUM CHLORIDE  
    COCAMIDOPROPYLAMINE OXIDE  
    CITRIC ACID MONOHYDRATE  
    Product Characteristics
    Color white (water-white, 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:65585-510-01 4 in 1 BOX
    1 1000 mL in 1 BAG
    2 NDC:65585-510-02 8 in 1 BOX
    2 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 10/22/2012
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    Name Address ID/FEI Business Operations
    Whisk Products, Inc. 834270639 manufacture(65585-510)
    Close