WHISKCARE 365 (CHLOROXYLENOL) SOAP [WHISK PRODUCTS, INC.]

WHISKCARE 365 (CHLOROXYLENOL) SOAP [WHISK PRODUCTS, INC.]
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NDC 65585-365-01, 65585-365-02, 65585-365-03, 65585-365-04, 65585-365-05, 65585-365-06, 65585-365-07, 65585-365-08, 65585-365-09, 65585-365-10
Set ID 420f941d-8ed0-42f4-901a-b04b29b51da6
Category HUMAN OTC DRUG LABEL
Packager Whisk Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • ​Active Ingredient

    Chloroxylenol 1% 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 6 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 thoroughly for at least 15 seconds.
    • Rinse completely and dry.
  • ​Inactive Ingedients

    Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Case Label - 8 x 1000 mL CleanShot Bags

  • INGREDIENTS AND APPEARANCE
    WHISKCARE 365 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-365
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Colorwhite (white, opaque liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-365-013500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/200010/03/2005
    2NDC:65585-365-023785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2000
    3NDC:65585-365-0324 in 1 BOX03/31/200009/20/2007
    3354.9 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:65585-365-0459 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2000
    5NDC:65585-365-0512 in 1 BOX03/31/2000
    5800 mL in 1 BAG; Type 0: Not a Combination Product
    6NDC:65585-365-06208198 mL in 1 DRUM; Type 0: Not a Combination Product03/31/2000
    7NDC:65585-365-07113562 mL in 1 DRUM; Type 0: Not a Combination Product10/13/2005
    8NDC:65585-365-086 in 1 BOX10/13/2005
    81750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    9NDC:65585-365-094 in 1 BOX10/13/2005
    94000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    10NDC:65585-365-1012 in 1 BOX10/03/2006
    10236.6 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    11NDC:65585-365-118 in 1 BOX06/16/2006
    111000 mL in 1 BAG; Type 0: Not a Combination Product
    12NDC:65585-365-121 in 1 CARTON03/31/2000
    12800 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 finalpart333E03/31/2000
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-365)

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