STERILE SALINE- sodium chloride injection, solution

Sterile saline by

Drug Labeling and Warnings

Sterile saline by is a Animal medication manufactured, distributed, or labeled by Covetrus, Nova-Tech, 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 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 at controlled room temperature 15°C - 30°C (59°F - 86°F).

PRECAUTIONS

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS

Questions? (855) 724-3461

Reorder #069169

18-807

RMS 92-1179

AH-069169-01

REV: 0719

NDC: 11695-6415-2

Sterilie - Preservative Free

Volume: 8.454 fl oz (250 mL)

Manufactured by:

Nova-Tech, Inc.

Grand Island, NE 68801

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

Lot No.

Exp. Date

Assembled in USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STERILE SALINE 
sodium chloride injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-6415
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Chloride	0.9 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6415-2	250 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-6415-5	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/22/2019

Labeler - Covetrus (603750329)

Registrant - Nova-Tech, Inc. (196078976)

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