Label: ANTIBACTERIAL- benzalkonium chloride soap

  • NDC Code(s): 65321-031-01, 65321-031-02
  • Packager: Rubbermaid Commercial Products LLC
  • 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 October 25, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    0.13% Benzalkonium Chloride

  • Purpose

    Antibacterial Hand Wash

  • Use

    For hand washing to decrease bacteria on skin. Repeat as needed.

  • Warnings

    • For external use only.

    • When using this product avoid contact with eyes. In case of eye contact, flush with water.

    • Stop use and ask a doctor, if irritation or redness persist.

    • Do not ingest.

    • Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    Wet hands, place hands under the dispenser to allow 0.8ml of hand wash to squirt into hands, wash thoroughly for at least 30 seconds, rinse hands thoroughly with potable water after washing.

  • Inactive Ingredients

    Water, Cetrimonium Chloride, Glycerin, Sodium Chloride, Lauramidopropylamine Oxide, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazilinone, Methylisothiazilinone.

  • Questions?

    1-800-347-9800 Mon – Fri, 8 AM – 5 PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by Rubbermaid Commercial Products LLC
    3124 Valley Avenue, Winchester, VA U.S.A. 22601-2694

  • PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label

    Rubbermaid®
    Commercial Products

    TECHNICAL CONCEPTS

    Antibacterial Lotion Soap

    To be used with OneShot® liquid dispensers
    800mL
    (27 FL. OZ.)

    PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65321-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65321-031-01800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/24/2017
    2NDC:65321-031-021600 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E07/24/2017
    Labeler - Rubbermaid Commercial Products LLC (049924368)
    Establishment
    NameAddressID/FEIBusiness Operations
    Abaco Partners LLC DBA Surefil964809417MANUFACTURE(65321-031)
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