Label: HYPERTONIC SALINE- sodium chloride injection, solution

  • 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 December 11, 2018

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  • INDICATIONS & USAGE

    INDICATIONS:

    For use in replacement therapy of sodium, chloride and water which may become depleted in many diseases.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:

    Horses/Cattle:  50 to 100 mL per 100 lb bodyweight.  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.

  • DOSAGE FORMS & STRENGTHS

    COMPOSITION:  Each 100 mL of sterile aqueous solution contains:

    Sodium Chloride.............................7.2 g

    Milliequivalents per liter

    Cations:

    Sodium.........................................1232mEq/L

    Anions:

    Chloride........................................1232mEq/L

    Total osmolarity is 2464 milliomoles per liter.

  • PRECAUTIONS

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

  • STORAGE AND HANDLING

    Store at controlled room temperature between 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

  • PRINCIPAL DISPLAY PANEL

    1000 mL

    VETONE

    Hypertonic Saline 7.2%

    Solution

    Sterile - Preservative Free

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

    Keep out of reach of children.

    For animal use only.

    Net Contents:  1000 mL

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  • INGREDIENTS AND APPEARANCE
    HYPERTONIC SALINE 
    sodium chloride injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-031
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37, Chloride Ion - UNII:Q32ZN48698) Sodium Chloride7.2 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-031-491000 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2007
    Labeler - MWI/VetOne (019926120)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda-MTC Animal Health256232216manufacture