Label: PENTOSOL- euthanasia injection, solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 12, 2023

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  • DESCRIPTION

    DESCRIPTION:

    Pentosol (euthanasia) Injection

    NDC 549245-030-10

    FOR VETERINARY EUTHANASIA ONLY.  Keep Out of Reach of Children. 

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    6 grains of pentobarbital sodium

    Net contents:  100 mL

  • DOSAGE AND ADMINISTRATION:

    Mulitple Dose Vial

    Dosage:  For intravenous (preferred), intracardial, intrapleural, or intraperitoneal injection.

    Small Animals:  Inject rapidly 1 mL per 10 lbs. of bady weight.  Minimum dose 1 mL.

    Horses and other Large Animals:  Inject rapidly 1 mL per 10 lbs. of obdy weight, to a maximum of 100 mL.

    Each mL contains:

    Pentobarbital sodium ..... 6 gr.

    Isopropyl alcohol .......... 10%

    Propylene glycol ........... 18%

    Benzyl alcohol .............. 2.0%

    Purified water ............... qs

    Green dye to establish a distinctive color.

    TAKE TIME - OBSERVE LABEL DIRECTIONS

  • WARNING:

    This is a highly toxic parenteral solution specifically designed for rapid, painless, and humane euthanasia of animals.

  • ENVIRONMENTAL HAZARD:

    This product is toxic to wildlife.  Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with state and local laws to prevent consumption of carcass material by scavenging wildlife.

  • ADVERSE REACTIONS

    To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Med-Pharmex at (909) 593-7875.  For additional information about adverse drug experience reporting for animals, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae.

    Manufactured by:

    Med-Pharmex, Inc.
    2727 Thompson Creek Road
    Pomona, CA 91767

    Rev.: 01/2023

  • PRINCIPAL DISPLAY PANEL

    Pentosol Container Label

  • INGREDIENTS AND APPEARANCE
    PENTOSOL 
    euthanasia injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54925-030
    Route of AdministrationINTRAVENOUS, INTRACARDIAC, INTRAPLEURAL, INTRAPERITONEALDEA ScheduleCII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PENTOBARBITAL SODIUM (UNII: NJJ0475N0S) (PENTOBARBITAL - UNII:I4744080IR) PENTOBARBITAL SODIUM390 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 0.10 mL  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.180 mL  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.02 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.01 mL  in 1 mL
    Product Characteristics
    Colorgreen (Green dye to establish a distinctive color.) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54925-030-25100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/03/2000
    Labeler - Med-Pharmex, Inc. (025353699)
    Registrant - Med-Pharmex, Inc. (025353699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Med-Pharmex, Inc.025353699manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Siegfried USA, LLC001213784api manufacture