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

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

Drug Label Information

Updated February 2, 2015

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

  • DESCRIPTION

    Balanced Salt Solution is a sterile physiological 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.

    Close
  • CLINICAL PHARMACOLOGY

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

    Close
  • 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.

    Close
  • WARNINGS

    • NOT FOR INJECTION OR INTRAVENOUS INFUSION.
    • Do not use unless product is clear, seal is intact, vacuum is present 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.
    • This solution contains no preservative, unused contents should be discarded.
    Close
  • 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.

    Close
  • 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.

    Close
  • DOSAGE AND ADMINISTRATION

    This 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 flip-off cap. 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.

    Close
  • HOW SUPPLIED

    Balanced Salt Solution ( Sterile Irrigating Solution) is supplied in a glass bottle using a grey butyl stopper and aluminum seal with a polypropylene flip-off cap.

    NDC 17478-921-95          500 mL in a 570 mL container.

    STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

    AKORN

    Manufactured for: Akorn, Inc.
    Lake Forest, IL 60045

    Made in Austria

    BSA0N Rev. 10/16

    Close
  • Principal Display Panel Text for Container Label:

    NDC 17478-921-95

    Balanced Salt Solution

    Sterile Irrigating Solution

    NOT FOR INTRAVENOUS USE SINGLE-DOSE UNIT

    Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%,
    calcium chloride •2H2O 0.048%, magnesium chloride •6H2O 0.03%, sodium
    acetate •3H2O 0.39%, sodium citrate • 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.

    STERILE 500 mL Rx Only

    Principal Display Panel Text for Container Label
    Close
  • INGREDIENTS AND APPEARANCE
    BALANCED SALT 
    sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and trisodium citrate dihydrate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-921
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    sodium chloride (UNII: 451W47IQ8X) (chloride ion - UNII:Q32ZN48698, sodium cation - UNII:LYR4M0NH37) sodium chloride 6.4 mg  in 1 mL
    potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152, chloride ion - UNII:Q32ZN48698) potassium chloride 0.75 mg  in 1 mL
    calcium chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB, chloride ion - UNII:Q32ZN48698) calcium chloride 0.48 mg  in 1 mL
    magnesium chloride (UNII: 02F3473H9O) (magnesium cation - UNII:T6V3LHY838, chloride ion - UNII:Q32ZN48698) magnesium chloride 0.3 mg  in 1 mL
    sodium acetate (UNII: 4550K0SC9B) (acetate ion - UNII:569DQM74SC, sodium cation - UNII:LYR4M0NH37) sodium acetate 3.9 mg  in 1 mL
    trisodium citrate dihydrate (UNII: B22547B95K) (anhydrous citric acid - UNII:XF417D3PSL) anhydrous citric acid 1.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    sodium hydroxide (UNII: 55X04QC32I)  
    hydrochloric acid (UNII: QTT17582CB)  
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-921-95 1 in 1 BOTTLE 11/27/2014
    1 500 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075503 11/27/2014
    Labeler - Akorn, Inc. (062649876)
    Close