STERILE SALINE SOLUTION- sodium chloride injection, solution 
Nova-Tech, Inc.
Reference Label Set Id: 40ee323f-8a84-4713-a9a5-b39e82f2ea35

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

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.

terile 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.

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.

FOR ANIMAL USE ONLY

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.

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.

Store between 15°C and 30°C (59°F and 86°F). Keep from freezing.

TAKE TIME OBSERVE LABEL DIRECTIONS

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

RMS# 92-2117

NDC: 65207-807-61

365207807613

1000 mL label500 mL label250 mL label1000 mL label bag

STERILE SALINE SOLUTION 
sodium chloride injection, solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:65207-807
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride0.9 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65207-807-601000 mL in 1 BOTTLE, PLASTIC
2NDC:65207-807-50500 mL in 1 BOTTLE, PLASTIC
3NDC:65207-807-25250 mL in 1 BOTTLE, PLASTIC
4NDC:65207-807-611000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/21/2019
Labeler - Nova-Tech, Inc. (196078976)
Registrant - Nova-Tech, Inc. (196078976)
Establishment
NameAddressID/FEIBusiness Operations
Nova-Tech, Inc.196078976manufacture

Revised: 1/2024
Document Id: 56d73d29-7b19-480c-bab0-55b4f1c8cd70
Set id: bdfce707-28cd-49ce-a9ea-4f342137e18e
Version: 3
Effective Time: 20240104
 
Nova-Tech, Inc.