Label: HEALTH CARE PERSONNEL HANDWASH- 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

    Triclosan (1%)

  • Purpose

    Antimicrobial

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • 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

    • Wet hands with water, then dispense an adequate amount of handwash onto the skin.
    • Wash vigorously all parts of the hand, fingers and nails for at least15 seconds.
    • Rinse and dry thoroughly.
  • Inactive Ingredients

    Water, Propylene Glycol, Citric Acid, Sodium Laureth Sulfate, Sodium cumenesulfonate, Ethanolamine, PEG-75 Lanolin, Hydroxyethyl Cellulose, Fragrance, Disodium EDTA, Yellow 6

  • Principal Display Panel

    NDC 64064-007-01

    DIN 02244159

    Health Care Personnel

    Handwash

    With 1% Triclosan

    Nettoyant Pour Les Mains

    Pour Le Personnel Soignant

    Contient 1% de Triclosan

    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/Importe par:

    Trans Canada Distribution Inc.

    Mississauga, ON L5L 5Y7

    Net Contents 54.04 Fl Oz (1600ml)

    Contenu Net 1,6 L

    Stock No. 64106

    No. De Stock 64106


  • PRINCIPAL DISPLAY PANEL

    007-01 1600 mL CliniShield HCP

  • INGREDIENTS AND APPEARANCE
    HEALTH CARE PERSONNEL HANDWASH 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64064-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Sodium Cumenesulfonate (UNII: 5798KA13PG)  
    Monoethanolamine (UNII: 5KV86114PT)  
    PEG-75 Lanolin (UNII: 09179OX7TB)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64064-007-011600 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/09/2011
    Labeler - Evonik Stockhausen, LLC (089906614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Evonik Stockhausen, LLC089906614manufacture
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