Label: SALINE- saline solution injection, solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL

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 April 15, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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.

  • VETERINARY INDICATIONS

    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.


  • STORAGE AND HANDLING

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

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • PRINCIPAL DISPLAY PANEL

    Container LabelContainer Label

  • INGREDIENTS AND APPEARANCE
    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