Label: PURE SOLUTIONS FOAMING HAND SANITIZING- benzalkonium chloride solution

  • 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 June 7, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium chloride 0.1%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • to decrease bacteria on the skin
    • recommended for repeated use
  • WARNINGS

    Warnings
    For external use only.

    When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

    Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply a small amount of product to palm of hand
    • rub thoroughly over all sufaces of both hands and allow to dry
  • STORAGE AND HANDLING

    Other information

    store between 15-30°C (59-86°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    cocamidopropyl betaine, glycerin, methylchloroisothiazolinone, methylisothiazonlinone, PEG-40 hydrogenated castor oi, tetrasodium EDTA, water

  • SPL UNCLASSIFIED SECTION

    Pure Solutions is a registered trademark of Urban Attitudes Holdings Ltd.

    Distributed by: Urban Attititudes Holdings Ltd.

    Great Neck, NY 11023 (516) 206-3672

    MADE IN PERU

  • PRINCIPAL DISPLAY PANEL

    puresolutions

    Foaming Hand Sanitizing Solution

    1.057 GALLONS (4 LITERS)

    Pure Solutions Foaming BZK Final

  • INGREDIENTS AND APPEARANCE
    PURE SOLUTIONS FOAMING HAND SANITIZING 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77185-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 0.1 L
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77185-003-044 L in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/08/2020
    Labeler - Urban Attitudes Holdings Ltd (117502692)
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