Label: HYPERTONIC SALINE 7.2%- 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 March 18, 2020

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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 preservatives. Do not use if solution is not clear. 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.

  • GENERAL PRECAUTIONS

    Sterile Solution Preservative Free

    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..........................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-30°C (59°F-86°F)

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured by:

    Nova-Tech, Inc.

    Grand Island, NE 68801 USA

    18-806
    RMS 92-344

    NDC: 65207-806-60

    Net Contents:

    1000 mL (33.81 fl oz)

    Assembled in USA

    Lot No.    Exp. Date

  • PRINCIPAL DISPLAY PANEL

    product label

  • INGREDIENTS AND APPEARANCE
    HYPERTONIC SALINE 7.2% 
    hypertonic saline injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:65207-806
    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:65207-806-601000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/18/2020
    Labeler - Nova-Tech, Inc. (196078976)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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