Sterile Saline Solution: Product Information

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.

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
(click image for full-size original)
500 mL label
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250 mL label
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Chloride (SODIUM CATION) Sodium Chloride 0.9 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65207-807-60 1000 mL in 1 BOTTLE, PLASTIC None
2 NDC:65207-807-50 500 mL in 1 BOTTLE, PLASTIC None
3 NDC:65207-807-25 250 mL in 1 BOTTLE, PLASTIC None
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 Operations
Nova-Tech, Inc. 196078976 manufacture

Revised: 03/2020 Nova-Tech, Inc.

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