PENTOBARSOL- euthanasia injection, solution

Pentobarsol by

Drug Labeling and Warnings

Pentobarsol by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products, LLC, Med-Pharmex, Inc., Siegfried USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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.

ADVERSE REACTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PENTOBARSOL 
euthanasia injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-085
Route of Administration	INTRAVENOUS, INTRACARDIAC, INTRAPLEURAL, INTRAPERITONEAL	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PENTOBARBITAL SODIUM (UNII: NJJ0475N0S) (PENTOBARBITAL - UNII:I4744080IR)	PENTOBARBITAL SODIUM	390 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	green (Green dye to establish a distinctive color.)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-085-25	250 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/11/2023

Labeler - Dechra Veterinary Products, LLC (362142734)

Registrant - Med-Pharmex, Inc. (025353699)

Establishment
Name	Address	ID/FEI	Business Operations
Med-Pharmex, Inc.		025353699	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Siegfried USA, LLC		001213784	api manufacture