Label: HYPERTONIC SALINE injection, solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 29, 2018

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  • INDICATIONS:

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

  • CAUTION:

    This product contains no pre-
    servatives. 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.

  • VETERINARY INDICATIONS

    FOR ANIMAL USE ONLY

  • WARNINGS AND PRECAUTIONS

    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 ................... 7.2 g

    Milliequivalents per liter

    Cations
    Sodium ......................... 1232 mEq/L
    Anions
    Chloride ........................ 1232 mEq/L

    Total osmolarity is 2464 milliosmoles per liter.

  • STORAGE AND HANDLING

    Store between 15°C and 30°C (59°F and 86°F)

  • GENERAL PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured by
    Nova-Tech, Inc.
    Grand Island, NE 68801

    RMS 92-548

    18-806-60

    Rev. 06-10

    NDC 57319-554-08

    Sterile - Preservative Free

    Net Contents: 1000 mL

    Manufactured for:
    Clipper Distributing Company, LLC
    St. Joseph, MO 64507

    Trademarks are property of
    Clipper Distributing Company, LLC

    Lot No.

    Exp. Date

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HYPERTONIC SALINE 
    hypertonic saline injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57319-554
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE7.2 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-554-081000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/16/2018
    Labeler - Phoenix (150711039)
    Registrant - Phoenix (150711039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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