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 August 20, 2019

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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. 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 - Preservative Free

    FOR ANIMAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

    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-86°F)

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Reorder #069179

    Manufactured by:

    Nova-Tech, Inc.

    Grand Island, NE 68801

    18-806
    RMS 92-1178

    NDC: 11695-6414-1

    Volume: 33.814 fl oz (1000 mL)

    Questions? (855) 724-3461

    Distributed by:
    Covetrus North America

    400 Metro Place North

    Dublin, OH 43017

    covetrus.com

    AH-069179-01
    Rev: 0719

    Lot No.    Exp. Date

    Assembled in USA

  • 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:11695-6414
    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:11695-6414-11000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/20/2019
    Labeler - Covetrus (603750329)
    Registrant - Covetrus (603750329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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