Label: CVS FOAMING HAND SANITIZER ANTIBACTERIAL- benzalkonium chloride liquid

  • 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 January 25, 2022

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  • Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.13

  • Purpose

    Antibacterial

  • Uses

    ♦
    hand sanitizer to help reduce bacteria on the skin that could cause disease
    ♦
    Recommended for repeated use
  • Warnings

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts

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

  • Directions

    ♦
    place enough product in your palm to thoroughly cover your hands
    ♦
    rub hands together briskly until dry
    ♦
    children under 6 years of age should be supervised when using this product
  • Other information

    ♦
    To prevent discoloration, avoid contact with clothing.
  • Inactive ingredients

    Cetrimonium Chloride, Citric Acid, Cocamidopropylamine Oxide, Cocamidopropyl Betaine, Glycerin, Propylene Glycol, Water.

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 222 mL Bottle Label

    ♥CVS
    Health™

    Foaming
    Hand
    Sanitizer

    INSTANT

    • Antibacterial
    • Alcohol free

    KILLS
    99.99%
    OF GERMS*

    Unscented

    7.5 FL OZ (222 mL)

    *Effective at eliminating more than 99.99%
    or many common harmful germs and
    bacteria in as little as 15 seconds.

    05-3201
    L0015035FB

    PRINCIPAL DISPLAY PANEL - 222 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CVS FOAMING HAND SANITIZER   ANTIBACTERIAL
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-584
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Cocamidopropylamine Oxide (UNII: M4SL82J7HK)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-584-01222 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E01/01/2015
    Labeler - CVS Health (062312574)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(69842-584)
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