SALINE- saline solution  injection, solution 
Clipper

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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Saline Solution 0.9%

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.

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 sterile 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 degrees C and 30 degrees C (59 degrees F and 86 degrees F).

TAKE TIME OBSERVE LABEL DIRECTIONS

Container LabelContainer Label

SALINE 
saline solution injection, solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57319-555
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57319-555-081000 mL in 1 BOTTLE, PLASTIC
2NDC:57319-555-06250 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/05/2014
Labeler - Clipper (150711039)
Registrant - Clipper (150711039)
Establishment
NameAddressID/FEIBusiness Operations
Nova-Tech, Inc.196078976manufacture
Establishment
NameAddressID/FEIBusiness Operations
Morton Salt, Inc137658043api manufacture

Revised: 4/2014
Document Id: 4387bb7c-2158-41b1-8180-7d079cdc004c
Set id: 570103c4-79e3-4c5d-a609-daf0aa0e2ac8
Version: 2
Effective Time: 20140415
 
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