INDICATIONS & USAGE SECTION.

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.

ADVERSE REACTIONS SECTION.

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.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. BSS Sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.

DESCRIPTION SECTION.

DESCRIPTION. BSS(R) Sterile Irrigating Solution is sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2o2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2o6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2o3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7o2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.

DOSAGE & ADMINISTRATION SECTION.

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 separate airway tube. Follow directions of the particular administration set to be used. Remove the blue flip-off cap. Clean and disinfect the rubber stopper by using 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. BSS(R) Sterile Irrigating Solution is supplied in glass bottle using grey butyl stopper and aluminum seal with blue polypropylene flip-off cap.250 mL in 325 mL container: NDC 0065-0795-25.500 mL in 635 mL container: NDC 0065-0795-50.STORAGE: Store at 36 77 (2 25C). 9012631-1115 Alcon(R)A Novartis company Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA (C) 2000-2003, 2015 Novartis.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 0065-0795-50BSS(R) Sterile Irrigating Solution (balanced salt solution)Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride o2H2O 0.048%, magnesium chloride o6H2O 0.03%, sodium acetate o3H2O 0.39%, sodium citrate o2H2O 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg. STERILE 500 mL Rx Only NOT FOR I.V. USE SINGLE DOSE UNIT Read accompanying insert. 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 precipitate. Discard unused contents. Do not use this container for more than one patient. STORAGE: Store at 36- 77F (2- 25C). ALCON(R) Novartis company ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA (C) 2001-2003, 2015 Novartis SINGLE USE ONLY Lot: Exp.: H14133-1115.

PRECAUTIONS SECTION.

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 and edema following ocular surgery in which BSS Sterile Irrigating Solution was used as an irrigating solution.

WARNINGS SECTION.

WARNINGS. NOT FOR INJECTION OR INTRAVENOUS INFUSION.o Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged.o Do not use if product is discolored or contains precipitate.o SINGLE patient use only. The contents of this bottle should not be used in more than one patient.o This solution contains no preservative, unused contents should be discarded.