Label: STERILE SALINE- sodium chloride injection, solution

  • NDC Code(s): 46066-807-25, 46066-807-50, 46066-807-60
  • Packager: Aspen Veterinary
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 19, 2019

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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.

  • CAUTION:

    This product contains no preservatives. Use entire
    contents when first opened. Discard any unused
    solution. Do not use if solution is not clear.

  • 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.

  • COMPOSITION:

    Each 100 mL of 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.

  • STORAGE AND HANDLING

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

  • CAUTION:

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

  • VETERINARY INDICATIONS

    For Animal Use Only

  • WARNINGS

    Keep Out of Reach of Children

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Distributed by:
    Aspen Veterinary Resources®, Ltd.
    Liberty, MO 64068 USA

    A250NT Rev. 05/15

    Maufactured by:
    Nova-Tech, Inc.
    Grand Island, NE 68801 USA

    18-807
    RMS# 92-509

    NDC# 46066-807-60

    NET CONTENTS:
    1000 mL (33.81 fl oz)

    Lot No.

    Exp. Date

  • PRINCIPAL DISPLAY PANEL

    1000 ml label500 ml label250 ml label

  • INGREDIENTS AND APPEARANCE
    STERILE SALINE 
    sodium chloride injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-807
    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:46066-807-25250 mL in 1 BOTTLE, PLASTIC
    2NDC:46066-807-50500 mL in 1 BOTTLE, PLASTIC
    3NDC:46066-807-601000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/14/2013
    Labeler - Aspen Veterinary (627265361)
    Registrant - Aspen Veterinary (627265361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture
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