Label: STERILE SALINE- sodium chloride injection, solution

  • NDC Code(s): 13985-807-25, 13985-807-50, 13985-807-60
  • Packager: MWI (VetOne)
  • 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 October 19, 2015

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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.

  • 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

    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).

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    STERILE SALINE 
    sodium chloride injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-807
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride0.9 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-807-25250 mL in 1 BOTTLE, PLASTIC
    2NDC:13985-807-50500 mL in 1 BOTTLE, PLASTIC
    3NDC:13985-807-601000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/17/2011
    Labeler - MWI (VetOne) (019926120)
    Registrant - MWI (VetOne) (019926120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Morton Salt137658043api manufacture