Label: PENTOSOL- euthanasia injection, solution
- NDC Code(s): 54925-030-25
- Packager: Med-Pharmex, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
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Drug Label Information
Updated January 12, 2023
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- 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 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 91767Rev.: 01/2023
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PENTOSOL
euthanasia injection, solutionProduct 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 (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:54925-030-25 100 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/03/2000 Labeler - Med-Pharmex, Inc. (025353699) 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