WHISKCARE 387 (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]

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WHISKCARE 387 (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]
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NDC 65585-583-01, 65585-583-02, 65585-583-03, 65585-583-04, 65585-583-05, 65585-583-06, 65585-583-07
Set ID d1817d6b-5a15-4bc5-bbdd-080935adcddb
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 0.1%

  • ​Purpose

    ​Skin Antimicrobial

  • ​Use

    reduces amount of bacteria on hands

  • ​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 irritaiton or redness develops, 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

    • Apply a palmful to hands and forearms.
    • Scrub thoroughly for at least fifteen seconds.
    • Rinse completely and dry.
  • ​Inactive Ingredients

    Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Fragrance, Yellow 5, Blue 1

  • PRINCIPAL DISPLAY PANEL

    ShortNeck Label (1 gallon)

  • INGREDIENTS AND APPEARANCE
    WHISKCARE 387 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-583
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (apple green (dispensed as a white foam)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-583-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/31/201706/30/2022
    2NDC:65585-583-026 in 1 BOX08/31/201706/30/2022
    21000 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:65585-583-038 in 1 BOX08/31/201706/30/2022
    31000 mL in 1 BAG; Type 0: Not a Combination Product
    4NDC:65585-583-046 in 1 BOX08/31/201706/30/2022
    4500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    5NDC:65585-583-056 in 1 BOX08/31/201706/30/2022
    51750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    6NDC:65585-583-064 in 1 BOX08/31/201706/30/2022
    64000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    7NDC:65585-583-073785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/201706/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/31/201706/30/2022
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-583)
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