JADE ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [WHISK PRODUCTS, INC.]

JADE ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [WHISK PRODUCTS, INC.]
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NDC 65585-582-01, 65585-582-02
Set ID f609d39f-ed42-4bce-baa4-febe9bf5e2e1
Category HUMAN OTC DRUG LABEL
Packager Whisk Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • ​Active Ingredient

    Chloroxylenol 0.75%

  • ​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 or palmful to hands and forearms.
    • Scrub thoroughly 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

  • INGREDIENTS AND APPEARANCE
    JADE ANTIBACTERIAL HAND 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-582
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.75 g  in 100 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 a white foam) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-582-018 in 1 BOX05/31/201709/30/2020
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:65585-582-028 in 1 BOX03/15/2019
    2900 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 finalpart333E05/31/2017
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-582)

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