WHISKCARE 367 (CHLOROXYLENOL) SOAP [WHISK PRODUCTS, INC.]

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WHISKCARE 367 (CHLOROXYLENOL) SOAP [WHISK PRODUCTS, INC.]
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NDC 65585-568-01, 65585-568-02, 65585-568-03, 65585-568-04, 65585-568-05, 65585-568-06, 65585-568-07
Set ID ec8f74f1-fe58-4e89-bbb1-59f057278293
Category HUMAN OTC DRUG LABEL
Packager Whisk Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART333
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  • ​Active Ingredient

    Chloroxylenol 0.75% w/w

  • ​Purpose

    Skin Antimicrobial

  • ​Use

    reduces amount of bacteria on hands

  • ​Warnings

    For external use only.  Do not use in eyes.
    Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours, consult a physician.

    Not for use on children under six months of age.
    For institutional and professional use only.

  • ​Directions

    • Wet hands and forearms.
    • Apply a small amount (5 mL) or palmful to hands and forearms.
    • Scrub throughly for at least fifteen seconds.
    • Rinse completely and dry.
  • ​Inactive Ingredients

    Water, Propylene Glycol, TEA-Lauryl Sulfate, Lauramide DEA, Fragrance, DMDM Hydantoin, Yellow 5, Blue 1

  • PRINCIPAL DISPLAY PANEL

    Case Label for 8 x 1000 mL CleanShot Bags

  • INGREDIENTS AND APPEARANCE
    WHISKCARE 367 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-568
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorgreen (green, dispensed as white foam) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-568-0159 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/06/2007
    2NDC:65585-568-026 in 1 BOX12/06/2007
    21750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:65585-568-033785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2007
    4NDC:65585-568-044 in 1 BOX12/06/200710/09/2014
    44000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    5NDC:65585-568-056 in 1 BOX12/06/2007
    5500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    6NDC:65585-568-068 in 1 BOX12/06/2007
    61000 mL in 1 BAG; Type 0: Not a Combination Product
    7NDC:65585-568-073 in 1 BOX01/08/201001/03/2017
    71200 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 finalpart333E12/06/2007
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-568)
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