Label: INSTANT HAND SANITIZER- alcohol 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 September 8, 2011

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  • Active Ingredient

    Ethanol (62%)

  • Purpose

    Hand Antiseptic

  • Uses

    Hand antiseptic to decrease bacteria on the skin.

  • Warnings

    Flammable, For external use only.

    Avoid contact with eyes. In case of accidental eye contact, flush eyes thoroughly with water.

    Discontinue use if irritation and redness develops.

  • Stop use and ask doctor if

    Skin or eye irritation persists 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

    • Dispense an adequate amount (approx. 5 mL), rubbing all surfaces of both hands for at least 15 seconds.
    • Allow to dry without wiping.
  • Inactive Ingredients

    Deionized Water, Isopropanol, Hydrogenated Starch Hydrolysate, Carbomer, THP Ethylendiamine, Fragrance

  • Principal Display Panel

    NDC 64064-002-02

    NPN 80023556

    Instant Hand

    Sanitizer

    No Rinsing

    Desinfectant

    Instantane Pour Les Mains

    Sans Rincage

    Clinishield

    Manufactured in U.S.A.

    Fabrique Aux E.-U.

    Evonik Stockhausen, Inc.

    Greensboro, NC 27406

    1-800-334-0242 www.CliniShield.com

    Imported by

    Trans Canada Distribution Inc.

    Mississauga, ON L5L 5Y7

    Net Contents 4 Fl Oz

    (118.5 mL)

    Contenu Net 118.5 mL

    Stock No. 87012

    No. De Stock 87012

  • PRINCIPAL DISPLAY PANEL

    00002-2 4oz CliniShield

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64064-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
    Edetol (UNII: Q4R969U9FR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64064-002-02118.5 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/06/2011
    Labeler - Evonik Stockhausen, LLC (089906614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Evonik Stockhausen, LLC089906614manufacture
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