STERILE SALINE SOLUTION- sodium chloride injection, solution

Sterile Saline Solution by

Drug Labeling and Warnings

Sterile Saline Solution by is a Animal medication manufactured, distributed, or labeled by Nova-Tech, Inc., Morton Salt. 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. Do not use if solution is not clear.

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 between 15°C and 30°C (59°F and 86°F).

PRECAUTIONS

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS

Manufactured by:

Nova-Tech, Inc.

Grand Island, NE 68801 USA

18-807

RMS# 92-346

NDC: 65207-807-60

Net Contents

1000 mL (33.81 fl oz)

Assembled in USA

Lot No.

Exp. Date

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STERILE SALINE SOLUTION 
sodium chloride injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 65207-807
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: 65207-807-60	1000 mL in 1 BOTTLE, PLASTIC
2	NDC: 65207-807-50	500 mL in 1 BOTTLE, PLASTIC
3	NDC: 65207-807-25	250 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/21/2019

Labeler - Nova-Tech, Inc. (196078976)

Registrant - Nova-Tech, Inc. (196078976)

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