Label: ALCOHOL FREE HAND SANITIZER- benzalkonium chloride aerosol, foam

  • NDC Code(s): 51053-500-10
  • Packager: Sanihealth Products Corporation
  • 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 May 24, 2010

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  • DOSAGE & ADMINISTRATION


    Directions

    Place a palmful (5 grams) in one hand. Spread onto both hands to wrist and rub into the skin until dry.

  • INACTIVE INGREDIENT


    Water (Aqua), Decyl Glucoside, Glycerin, Fragrance, DMDM Hydantoin
  • BOXED WARNING (What is this?)



    Warnings:

    For external use only.

    Keep out of reach of children.

    Avoid eye contact. Should contact occur, rinse thoroughly with water.

    If swallowed or irritation develops, discontinue use and consult a health care practitioner.

  • INDICATIONS & USAGE



    Use

    Use as part of your daily cleansing routine when soap and water are not available, or to supplement hand washing.

  • ACTIVE INGREDIENT



    Active Ingredient                     Purpose

    Benzalkonium Chloride 0.12%   Antiseptic

  • PRINCIPAL DISPLAY PANEL


    label

    Mission Linen supply

    Mission linen and uniform service

    Alcohol free hand sanitizer

    benzalkonium chloride 0.12%

    High performance alcohol free foam hand sanitizer

    1 L (33.8 U.S. OZ)

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51053-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51053-500-101000 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/24/2010
    Labeler - Sanihealth Products Corporation (244200478)