MANNITOL 20%- mannitol injection

Mannitol 20% by

Drug Labeling and Warnings

Mannitol 20% by is a Animal medication manufactured, distributed, or labeled by Clipper, Nova-Tech, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS:

Mannitol Injection 20% is indicated for use as an osmotic diuretic in canine species. Mannitol is essentially inert metabolically. When given parenterally, it is freely filtered at the glomerulus which produces osmotic diuresis as more than 90% of the mannitol injected escapes reabsorption.

Each 100 mL Contains:

Mannitol USP...................................20 g

Water for Injection...........................q.s.

This solution contains 1098 mOsmols/Liter

Dosage and Administration:

The usual canine dosage administered intravenously is 1.5 - 2.0 g per Kg body weight given over a 30 minute period. This is approximately 3.4-4.5 mL/lb of body weight.

Note:

Crystals of mannitol may form in a 20% saturated solution of mannitol. Dissolve the crystals by warming in hot water or autoclaving for 15 minutes. Cool to body temperature before administering. This is a single dose vial that contains no preservatives. Use entire contents when first opened or resterilize by autoclaving.

STORAGE AND HANDLING

Store at temperatures between 15°and 30°C (59°-86°F).

SPL UNCLASSIFIED SECTION

Manufactured by: Nova-Tech, Inc. Grand Island, NE 68801 for Neogen Corporation

Item No. 09061

1072-022114

Lot No.:

Exp. Date

NDC: 57319-521-05

Mannitol Injection 20%

Sterile Solution

Net Contentes: 100 mL

PhoenixTM

Manufactured for:

Clipper Distributing Company, LLC.

St. Joseph, MO 64507

Trademares are property of Clipper Distributing Company, LLC

WARNINGS AND PRECAUTIONS

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Take Time Observe Label Directions

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

MANNITOL 20%

INGREDIENTS AND APPEARANCE

MANNITOL 20% 
mannitol injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 57319-521
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)	MANNITOL	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57319-521-05	100 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/27/2011

Labeler - Clipper (150711039)

Registrant - Nova-Tech, Inc (196078976)

Establishment
Name	Address	ID/FEI	Business Operations
Nova-Tech, Inc		196078976	manufacture