Label: STERILE SALINE SOLUTION- sodium chloride injection, solution
- NDC Code(s): 65207-807-25, 65207-807-50, 65207-807-60, 65207-807-61
- Packager: Nova-Tech, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 4, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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
- CAUTION:
-
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
- PRECAUTIONS
- INFORMATION FOR OWNERS/CAREGIVERS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
STERILE SALINE SOLUTION
sodium chloride injection, solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:65207-807 Route of Administration INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 0.9 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65207-807-60 1000 mL in 1 BOTTLE, PLASTIC 2 NDC:65207-807-50 500 mL in 1 BOTTLE, PLASTIC 3 NDC:65207-807-25 250 mL in 1 BOTTLE, PLASTIC 4 NDC:65207-807-61 1000 mL in 1 BAG 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 Business Operations Nova-Tech, Inc. 196078976 manufacture