Sterile Saline Solution by Nova-Tech, Inc. Sterile Saline Solution

Drug Details [pdf]

STERILE SALINE SOLUTION- sodium chloride injection, solution
Nova-Tech, Inc.

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.

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Sterile Saline Solution

Active Ingredient:

Each 100 mL contains Sodium Chloride 0.9 g, in Water for Injection.

mEq/L: Sodium 154.

Osmolarity: 308 mOsmol/liter.

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.

Caution:

This product contains no preservatives. Use entire contents when first opened. Discard any unused solution. Sterile nonpyrogenic solution. Use only if solution is clear and container is undamaged. 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 pharamceuticals and biologicals where compatible, and for washing mucous membranes and other tissue surfaces. Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found or if the solution contains visible solid particles.

KEEP OUT OF REACH OF CHILDREN

RX only.

CAUTION:

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

For Animal Use Only

Storage:

Store between 15°C - 30°C. Keep from freezing.

Assembled in the U.S.A.

18-807

RMS# 92-2117

NDC: 65207-807-61

365207807613

1000 mL (33.81 fl. oz.)

Nova-Tech™

Animal Health

1000 mL label

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 65207-807-61	1000 mL in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/21/2023	01/04/2024

Labeler - Nova-Tech, Inc. (196078976)

Revised: 1/2024

Document Id: a47310b9-6f85-4ae3-8578-b290904561a8

Set id: 40ee323f-8a84-4713-a9a5-b39e82f2ea35

Version: 2

Effective Time: 20240104