SALINE- saline solution injection, solution

Saline by

Drug Labeling and Warnings

Saline by is a Animal medication manufactured, distributed, or labeled by Clipper, Nova-Tech, Inc., Morton Salt, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS:

For use in replacement therapy of sodium, chloride and water which may become depleted in many diseases.  Because this solution is isotonic with body fluids, it may also be used as a solvent or diluent, for antibiotics and other pharmaceuticals and biologicals where compatible, and for washing mucous membranes and other tissue surfaces.

CAUTION:

This product contains no preservatives.  Use entire contents when first opened.  Discard any unused solution.

DOSAGE AND ADMINISTRATION:

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.  When used as a solvent or diluent for pharmaceuticals and biologicals, follow manufacturer's directions.

VETERINARY INDICATIONS

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION:

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

COMPOSITION:

Each 100 mL of sterile aqueous solution contains:

Sodium Chloride ....................................... 0.9 g

            Milliequivalents per liter

Cations

    Sodium ....................................... 154 mEq/L

Anions

    Chloride  ..................................... 154 mEq/L

Total osmolarity is 308 milliosmoles per liter.

STORAGE AND HANDLING

Store between 15 degrees C and 30 degrees C (59 degrees F and 86 degrees F).

PRECAUTIONS

TAKE TIME OBSERVE LABEL DIRECTIONS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALINE 
saline solution injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 57319-555
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	0.9 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57319-555-08	1000 mL in 1 BOTTLE, PLASTIC
2	NDC: 57319-555-06	250 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/05/2014

Labeler - Clipper (150711039)

Registrant - Clipper (150711039)

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

Establishment
Name	Address	ID/FEI	Business Operations
Morton Salt, Inc		137658043	api manufacture