Sterile Saline Solution

Sterile Saline Solution

Drug Labeling and Warnings

Drug Details

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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

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.

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.

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

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

1000 mL Label

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
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
Establishment
NameAddressID/FEIBusiness Operations
Morton Salt137658043api manufacture

Revised: 8/2019
 
Nova-Tech, Inc.


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