Label: CLINISHIELD INSTANT HAND SANITIZER FRAGRANCE FREE- ethanol gel

  • 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 20, 2011

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  • Active Ingredient

    Ethanol (70%)

  • 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 thorough with water.

    Stop use and ask doctor if

    Skin or eye irritation persists for more than 72 hours.

    Keep Out of Reach of Children

    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 over all surfaces of both hands for at least 15 seconds. Allow to dry without wiping.

  • Inactive Ingredients

    Deionized Water, Isopropanol, Hydrogenated Starch Hydrolysate, THP Ethylenediamine, Polyacrylic Acid

  • Principal Display Panel

    Instant Hand

    Sanitizer 70%

    Fragrance Free

    Desinfectant 80%

    Instantane Pour Les Mains

    Sans Fragrance

    CliniShield

    Manufactured in U.S.A.

    Fabrique Aux E.-U.

    Evonik Stockhausen, LLC

    Greensboro, NC 27406

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

    Imported by Trans Canada Distribution Inc.

    Mississauga, ON L5L 5Y7

    Net Contents 33.82 Fl Oz

    (1000 mL)

    Contenu Net 1 L

    Stock No. 34895

    No. De Stock 31795

    CliniShield Instant Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    CLINISHIELD INSTANT HAND SANITIZER FRAGRANCE FREE 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64064-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Edetol (UNII: Q4R969U9FR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64064-0002-71000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/15/2011
    Labeler - Evonik Stockhausen, LLC (089906614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Evonik Stockhausen, LLC089906614manufacture
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