WHISKCARE 377 FREE (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]

WHISKCARE 377 FREE (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]
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NDC 65585-578-01, 65585-578-02
Set ID f857f09e-9ad5-4ec5-88cf-f774025fbedb
Category HUMAN OTC DRUG LABEL
Packager Whisk Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

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

  • 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.
  • Inactive Ingredients

    Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    8 x 1000 mL Bags

  • INGREDIENTS AND APPEARANCE
    WHISKCARE 377 FREE 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-578
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.00 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Colorwhite (water white - colorless, dispensed as a white foam) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-578-018 in 1 BOX04/06/2016
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:65585-578-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/06/2016
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-578) , pack(65585-578) , label(65585-578)

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