Pentosol: Product Information

PENTOSOL- pentobarbital sodium injection, solution
Med-Pharmex, Inc.

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.

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.

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

Pentosol Container Label
(click image for full-size original)

PENTOSOL
euthanasia injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54925-030
Route of Administration INTRAVENOUS, INTRACARDIAC, INTRAPLEURAL, INTRAPERITONEAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENTOBARBITAL SODIUM (PENTOBARBITAL) PENTOBARBITAL SODIUM 390 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL 0.10 mL in 1 mL
PROPYLENE GLYCOL 0.180 mL in 1 mL
BENZYL ALCOHOL 0.02 mL in 1 mL
WATER 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 Multilevel Packaging
1 NDC:54925-030-25 100 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/03/2000
Labeler — Med-Pharmex, Inc. (025353699)
Registrant — Med-Pharmex, Inc. (025353699)
Establishment
Name Address ID/FEI Operations
Med-Pharmex, Inc. 025353699 manufacture
Establishment
Name Address ID/FEI Operations
Siegfried USA, LLC 001213784 api manufacture

Revised: 01/2023 Med-Pharmex, Inc.

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