Label: STERILE SALINE- sodium chloride injection, solution

  • NDC Code(s): 11695-6415-2, 11695-6415-5
  • Packager: Covetrus
  • 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 2, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • 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.

  • 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.

  • VETERINARY INDICATIONS

    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 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 at controlled room temperature 15°C - 30°C (59°F - 86°F).

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Questions? (855) 724-3461

    Reorder #069169

    18-807

    RMS 92-1179

    AH-069169-01

    REV: 0719

    NDC: 11695-6415-2

    Sterilie - Preservative Free

    Volume: 8.454 fl oz (250 mL)

    Manufactured by:

    Nova-Tech, Inc.

    Grand Island, NE 68801

    Distributed by:

    Covetrus North America

    400 Metro Place North

    Dublin, OH 43017

    covetrus.com

    Lot No.

    Exp. Date

    Assembled in USA

  • PRINCIPAL DISPLAY PANEL

    250 mL Label250 mL Label500 mL Label

  • INGREDIENTS AND APPEARANCE
    STERILE SALINE 
    sodium chloride injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-6415
    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:11695-6415-2250 mL in 1 BOTTLE, PLASTIC
    2NDC:11695-6415-5500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/22/2019
    Labeler - Covetrus (603750329)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

Related Resources

Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!