Label: BALANCED SALT- sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and sodium citrate solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/11

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

  • DESCRIPTION

    Balanced Salt Solution Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2·2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2·6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2·3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7·2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.

    The pH is approximately 7.0.

    The osmolality is approximately 300 mOsm/Kg.

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  • CLINICAL PHARMACOLOGY

    Balanced Salt Solution Sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.

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  • INDICATIONS AND USAGE

    For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

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  • WARNINGS

    • NOT FOR INJECTION OR INTRAVENOUS INFUSION.
    • Do not use unless product is clear, seal is intact and container is undamaged.
    • Do not use if product is discolored or contains a precipitate.
    • SINGLE patient use only. The contents of this bottle should not be used in more than one patient.
    • The use of additives with this solution may cause corneal decompensation.
    • This solution contains no preservative, unused contents should be discarded.
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  • PRECAUTIONS

    Open under aseptic conditions only.

    Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

    There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution Sterile Irrigating Solution was used as an irrigating solution.

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  • ADVERSE REACTIONS

    Irrigation or any other trauma may result in corneal swelling or bullous keratopathy.

    Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

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  • DOSAGE AND ADMINISTRATION

    The irrigating solution should be used according to standard format for each surgical procedure. Note: Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow directions of the particular administration set to be used. Remove the aluminum tab. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.

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  • HOW SUPPLIED

    Balanced Salt Solution Sterile Irrigating Solution is supplied in a glass bottle using a gray butyl stopper and aluminum closure with a tear tab.

    NDC REF Size
    Balanced Salt Solution Sterile Irrigating Solution
    0264-2514-10 S2514-10 500 mL
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  • STORAGE

    Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from freezing.

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  •  

    Rx Only

    Issued: November 2009

    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    Y36-002-712

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  • PRINCIPAL DISPLAY PANEL - 500 mL Label

    Balanced Salt Solution

    Sterile Irrigating Solution

    NDC 0264-2514-10
    REF S2514-10

    500 mL

    NOT FOR I.V. USE
    SINGLE USE ONLY

    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    PRINCIPAL DISPLAY PANEL - 500 mL Label
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  • INGREDIENTS AND APPEARANCE
    BALANCED SALT 
    sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0264-2514
    Route of Administration IRRIGATION DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Chloride (SODIUM CATION) Sodium Chloride 6.4 mg  in 1 mL
    Potassium Chloride (POTASSIUM CATION) Potassium Chloride 0.75 mg  in 1 mL
    Calcium Chloride (CALCIUM CATION) Calcium Chloride 0.48 mg  in 1 mL
    Magnesium Chloride (MAGNESIUM CATION) Magnesium Chloride 0.3 mg  in 1 mL
    Sodium Acetate (SODIUM CATION) Sodium Acetate 3.9 mg  in 1 mL
    Sodium Citrate (SODIUM CATION) Sodium Citrate 1.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Hydroxide  
    Hydrochloric Acid  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0264-2514-10 12 in 1 CASE
    1 500 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091387 02/03/2010
    Labeler - B. Braun Medical Inc. (002397347)
    Establishment
    Name Address ID/FEI Business Operations
    B Braun Medical Inc 037425308 MANUFACTURE
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