WHISKCARE 357 (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]

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WHISKCARE 357 (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]
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NDC 65585-509-01, 65585-509-02, 65585-509-03, 65585-509-04, 65585-509-05, 65585-509-06, 65585-509-07, 65585-509-08
Set ID 96c9549d-1e57-4b44-aea3-87c08417b7fc
Category HUMAN OTC DRUG LABEL
Packager Whisk Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

    • For hand washing 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 devleops, 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.

  • Directions

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

    Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Package Label - ShortNeck - 1 Gallon

  • INGREDIENTS AND APPEARANCE
    WHISKCARE 357 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-509
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Colorwhite (water-white, dispensed as a white foam) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-509-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/29/201203/31/2022
    2NDC:65585-509-02208198 mL in 1 DRUM; Type 0: Not a Combination Product10/29/201203/31/2022
    3NDC:65585-509-038 in 1 BOX10/29/201203/31/2022
    31000 mL in 1 BAG; Type 0: Not a Combination Product
    4NDC:65585-509-046 in 1 BOX10/29/201203/31/2022
    4500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    5NDC:65585-509-056 in 1 BOX10/29/201203/31/2022
    51750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    6NDC:65585-509-064 in 1 BOX10/29/201203/31/2022
    64000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    7NDC:65585-509-073785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/29/201203/31/2022
    8NDC:65585-509-083 in 1 BOX10/29/201203/31/2022
    81200 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/29/201203/31/2022
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-509)
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