Animal NDC 65207-807-50 Sterile Saline Solution

Sodium Chloride

Animal Product Information

Field Name Field Value
Animal NDC Code 65207-807-50
Proprietary Name Sterile Saline Solution What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sodium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Nova-tech, Inc.
Product Type Prescription Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Sodium Chloride
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Sterile Saline Solution Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Veterinary Indications



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.


Storage And Handling



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


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

RMS# 92-2117

NDC: 65207-807-61

365207807613


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.