Mannitol 20%: Product Information

MANNITOL 20%- mannitol injection
Clipper

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.

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.

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

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

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%

Mannitol 20%
(click image for full-size original)

MANNITOL 20%
mannitol injection
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57319-521
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MANNITOL (MANNITOL) MANNITOL 20 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57319-521-05 100 mL in 1 VIAL, SINGLE-USE None
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 Operations
Nova-Tech, Inc 196078976 manufacture

Revised: 11/2019 Clipper

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