Label: STERILE SALINE - sodium chloride injection, solution

  • NDC Code(s): 46066-807-25, 46066-807-50, 46066-807-60
  • Packager: Aspen Veterinary
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 02/13

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  • 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.

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  • CAUTION:

    This product contains no preservatives. Use entire contents when first opened. Discard any unused solution. Do not use if solution is not clear.

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  • 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.
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  • 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.


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  • STORAGE AND HANDLING

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

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  • CAUTION:

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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  • VETERINARY INDICATIONS

    FOR ANIMAL USE ONLY

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  • WARNINGS

    KEEP OUT OF REACH OF CHILDREN


    TAKE TIME OBSERVE LABEL DIRECTIONS

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  • INGREDIENTS AND APPEARANCE
    STERILE SALINE 
    sodium chloride injection, solution
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:46066-807
    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 Marketing Start Date Marketing End Date
    1 NDC:46066-807-25 250 mL in 1 BOTTLE, PLASTIC
    2 NDC:46066-807-50 500 mL in 1 BOTTLE, PLASTIC
    3 NDC:46066-807-60 1000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/14/2013
    Labeler - Aspen Veterinary (627265361)
    Registrant - Aspen Veterinary (627265361)
    Establishment
    Name Address ID/FEI Business Operations
    Nova-Tech, Inc. 196078976 manufacture
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