HYPERTONIC SALINE 7.2 % injection, solution

Hypertonic Saline 7.2 % by

Drug Labeling and Warnings

Hypertonic Saline 7.2 % by is a Animal medication manufactured, distributed, or labeled by Vedco, Laboratorios Biogalenic, K+S Minerals and Agriculture GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

HYPERTONIC SALINE 7.2 %- hypertonic saline 7.2 % injection, solution

Vedco

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

Hypertonic Saline Solution 7.2%

Sterile - Preservative Free

KEEP OUT OF REACH OF CHILDREN

ACTIVE INGREDIENT

Each 100 mL of sterile aqueous solution contains:

Sodium Chloride.................................................7.2 g

Milliequivalents per liter:

Cations Sodium.......................................1232 mEq/L
Anions Chloride......................................1232 mEq/L

Total osmolarity is 2464 milliosmoles per litter.

INDICATION

For use in replacement therapy of sodium, chloride and water which may become depleted in many diseases.

DOSAGE AND AND ADMINISTRATION

50 to 100 mL per lb bodyweight. Warm to body temperature and administer slowly by intravenous or subcutaneous injection. The amount and rate of administration must be judged by the veterinarian in relation to the condition being treated and the clinical response of the animal, being careful to avoid overhydration.

CAUTION

This product contains no preservatives. Do not use if solution is not clear. Use entire contents when first opened. Discard any unused solution.

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

STORAGE

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

INFORMATION FOR OWNERS/CAREGIVERS

Distributed By

VEDCO, INC.

St. Joseph, MO 64507

Made in El Salvador

Net Contents: 1000 mL

TABLE

CONTENTS	NDC	VINV #
1000 mL	50989-884-17	VINV-EQUI-7HSS

PRINCIPAL DISPLAY PANEL

NDC: 50989-884-17

ULTIGIENE

TERMINALLY STERILIZED

HYPERTONIC SALINE SOLUTION 7.2%

NET CONTENTS: 1000 mL

VEDCO

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION: Federal Law (U.S.A) restricts this drug to use by or on the order of a licensed veterinarian

INGREDIENTS AND APPEARANCE

HYPERTONIC SALINE 7.2 % 
hypertonic saline 7.2 % injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50989-884
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	7.2 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50989-884-17	1000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/09/2019

Labeler - Vedco (021634266)

Registrant - Vedco (021634266)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Biogalenic		851259507	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
K+S Minerals and Agriculture GmbH		507531213	api manufacture