STERILE SALINE- sodium chloride solution

Sterile Saline by

Drug Labeling and Warnings

Sterile Saline by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., Bimeda-MTC, US Salt LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Sterile Saline Solution

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.

Net Contents: 1000 mL

INDICATIONS & USAGE

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.

PRECAUTIONS

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

DOSAGE & ADMINISTRATION

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.

DESCRIPTION

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.

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STERILE SALINE  
sodium chloride solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-2690
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	0.9 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-2690-9	1000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2006

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda-MTC		256232216	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
US Salt LLC		002246361	api manufacture