Label: ASSURED FOAMING HAND SANITIZER- 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 March 9, 2015

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    ■ for washing hands to decrease bacteria on the skin ■ recommended for repeated use.

  • Warnings

    For external use only

  • When using this product

    avoid contact with the eyes. If contact occurs, flush eyes with water.

  • Stop use and ask a doctor if 

    irritation or rash develops and continues 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

    ■ wet hands thoroughly with product and rub into skin until dry ■ for children under 6, use only under adult supervision ■ not recommended for infants ■ no rinsing required.

  • Inactive ingredients

    water, cetrimonium chloride, disodium cocoamphodiacetate, dimethicone copolyol, fragrance, tocopherol acetate

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    ASSURED  FOAMING HAND SANITIZER
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0315-7221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2015
    Labeler - Greenbrier International Inc (610322518)
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