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 February 21, 2022

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

  • SPL UNCLASSIFIED SECTION

    Y36-003-042 LD-721-1

    Package Insert

    EXCEL® CONTAINER

    Rx only

  • DESCRIPTION

    Balanced Salt Solution Sterile Irrigating Solution is a sterile balanced salt solution in 500 mL single-dose EXCEL® flexible containers. Each mL contains 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.

    The EXCEL® plastic container is made from a multilayered film. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

    Addition of medication should be accomplished using complete aseptic technique.

    The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

  • CLINICAL PHARMACOLOGY

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

  • 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.

  • WARNINGS

    • NOT FOR INJECTION OR INTRAVENOUS INFUSION.
    • Do not use unless overwrap is intact, 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 container should not be used in more than one patient.
    • This solution contains no preservative, unused contents should be discarded.
  • 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.

  • ADVERSE REACTIONS

    Irrigation or any other trauma to the corneal endothelium 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.

  • DOSAGE AND ADMINISTRATION

    The irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used.  Allow the fluid to flow and remove air from the tubing before irrigation begins.

  • HOW SUPPLIED

    Balanced Salt Solution Sterile Irrigating Solution is supplied in sterile and nonpyrogenic 500 mL single-dose EXCEL® flexible containers with clear overwrap, 24 per case.

    Not made with natural rubber latex, PVC or DEHP.

     NDC REFSize 
     Balanced Salt Solution Sterile Irrigating Solution  
     0264-1945-10 L2514 500 mL

  • 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.

    Revised: August 2021

    EXCEL® is a registered trademark of B. Braun Medical Inc.

  • Directions for Use of EXCEL® Container

    Caution: Do not use plastic containers in series connection.

    To Open

    Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired.

    NOTE: Before use, perform the following checks:

    Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.

    Use only if solution is clear and container and seals are intact.

    Preparation for Administration

    1. Remove plastic protector from sterile set port at bottom of container.
    2. Attach administration set. Refer to complete directions accompanying set.

    To Add Medication

    Warning: Some additives may be incompatible.

    To Add Medication Before Solution Administration

    1. Prepare medication site.
    2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
    3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

    To Add Medication During Solution Administration

    1. Close clamp on the set.
    2. Prepare medication site.
    3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Evacuate both ports by tapping and squeezing them while container is in the upright position.
    6. Mix solution and medication thoroughly.
    7. Return container to in use position and continue administration.

  • SPL UNCLASSIFIED SECTION

    B. Braun Medical Inc.

    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

  • PRINCIPAL DISPLAY PANEL - 500 mL Label

    Balanced Salt Solution
    Sterile Irrigating Solution

    NOT FOR INTRAVENOUS USE
    SINGLE USE ONLY

    REF L2514

    NDC 0264-1945-10

    500 mL
    EXCEL® CONTAINER

     Each mL contains 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.

    pH: approximately 7.0; Osmolality: approximately 300 mOsm/Kg

    WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION.
    Do not use unless overwrap is intact, product is clear, seal is intact, and container is undamaged.
    Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use
    this container for more than one patient. See package insert.

    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.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

    Y94-003-436 LD-720-1

    EXCEL is a registered trademark of B. Braun Medical Inc.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    500 mL Container Label

    500 mL Container Label

  • INGREDIENTS AND APPEARANCE
    BALANCED SALT 
    sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-1945
    Route of AdministrationIRRIGATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6.4 mg  in 1 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE0.75 mg  in 1 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE0.48 mg  in 1 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE0.3 mg  in 1 mL
    SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM ACETATE3.9 mg  in 1 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE1.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0264-1945-10500 mL in 1 BAG; Type 0: Not a Combination Product01/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09138701/28/2022
    Labeler - B. Braun Medical Inc. (002397347)