Label: PENTOBARSOL- euthanasia injection, solution
- NDC Code(s): 17033-085-25
- Packager: Dechra Veterinary Products, LLC
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: CII
- Marketing Status: unapproved drug other
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 11, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DESCRIPTION
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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:
- ENVIRONMENTAL HAZARD:
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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 66211Rev.: 01/2023
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INGREDIENTS AND APPEARANCE
PENTOBARSOL
euthanasia injection, solutionProduct 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
