PENTOBARSOL- euthanasia injection, solution 
Dechra Veterinary Products, LLC

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.

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Pentobarsol Injection

DESCRIPTION:

Pentobarsol (euthanasia) Injection

NDC 17033-085-25

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:  250 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.

To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Dechra at (866) 933-2472.  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.

PENTOBARSOL is a trademark of Dechra Vetrinary Products, LLC.

Manufactured for:

Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211

Rev.: 01/2023

Pentobarsol Container Label

PENTOBARSOL 
euthanasia injection, solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:17033-085
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:17033-085-25250 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/11/2023
Labeler - Dechra Veterinary Products, LLC (362142734)
Registrant - Med-Pharmex, Inc. (025353699)
Establishment
NameAddressID/FEIBusiness Operations
Med-Pharmex, Inc.025353699manufacture
Establishment
NameAddressID/FEIBusiness Operations
Siegfried USA, LLC001213784api manufacture

Revised: 1/2023
Document Id: 257a9904-e41a-486f-be05-8f46929071e7
Set id: 1303b8ff-9bff-487b-b953-55b3b5080ad6
Version: 1
Effective Time: 20230111
 
Dechra Veterinary Products, LLC