NORTH WOODS GERM STUFF (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]

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NORTH WOODS GERM STUFF (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]
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NDC 65585-515-01
Set ID 357d64ec-227b-4847-8cf1-de1cec64d691
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 2.5%

  • Purpose

    Antibacterial

  • Use

    Reduces amount of bacteria on hands

  • Warnings

    For external use only.

    Avoid contact wih eyes.

    Harmful if swallowed.  If swallowed, call a physician.

    Discontinue use if irritation or redness develops.  If irritation persists for more than 72 hours, consult a physician.

    KEEP OUT OF REACH OF CHILDREN.

  • 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.

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Back Label with Drug Facts

    Front Label

  • INGREDIENTS AND APPEARANCE
    NORTH WOODS GERM STUFF 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Coloryellow (very pale yellow - very pale gold) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-515-016 in 1 BOX07/02/2014
    12500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/02/2014
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-515)
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