Sterile Saline: Product Information

STERILE SALINE- sodium chloride injection, solution
MWI (VetOne)

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.

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.

Keep out of reach of children.

For animal use only.

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.

CAUTION:

This product contains no preservatives. Use entire contents when first opened. Discard any unused solution.

STORAGE:

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

TAKE TIME OBSERVE LABEL DIRECTIONS

STERILE SALINE sodium chloride injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:13985-807 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:13985-807-25 250 mL in 1 BOTTLE, PLASTIC None 2 NDC:13985-807-50 500 mL in 1 BOTTLE, PLASTIC None 3 NDC:13985-807-60 1000 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/17/2011

Labeler — MWI (VetOne) (019926120)

Registrant — MWI (VetOne) (019926120)

Establishment
Name	Address	ID/FEI	Operations
Nova-Tech, Inc.		196078976	manufacture

Establishment
Name	Address	ID/FEI	Operations
Morton Salt		137658043	api manufacture

Revised: 10/2015 MWI (VetOne)