Label: WHISKCARE 387- benzalkonium chloride soap

  • NDC Code(s): 65585-513-01, 65585-513-02, 65585-513-03, 65585-513-04, view more
    65585-513-05, 65585-513-06, 65585-513-07, 65585-513-08
  • Packager: Whisk Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 22, 2021

If you are a consumer or patient please visit this version.

  • ​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 irritation 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

  • PRINCIPAL DISPLAY PANEL

    ShortNeck Label - 1 Gallon

  • INGREDIENTS AND APPEARANCE
    WHISKCARE 387 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-513
    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
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    Product Characteristics
    Colorwhite (colorless, water-white (dispensed as a white foam)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-513-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/15/2020
    2NDC:65585-513-026 in 1 BOX04/15/2020
    21000 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:65585-513-038 in 1 BOX04/15/2020
    31000 mL in 1 BAG; Type 0: Not a Combination Product
    4NDC:65585-513-046 in 1 BOX04/15/2020
    4500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    5NDC:65585-513-056 in 1 BOX04/15/2020
    51750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    6NDC:65585-513-063785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2020
    7NDC:65585-513-074 in 1 BOX03/04/2021
    71000 mL in 1 BAG; Type 0: Not a Combination Product
    8NDC:65585-513-084 in 1 BOX03/17/2021
    81000 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 finalpart333E04/15/2020
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-513)