BSS

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: 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.

DESCRIPTION: BSS ™ 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 (CaCl 2 •2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 •6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 •3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 •2H 2 O) 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 AND ADMINISTRATION: This irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Remove the outer overwrap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bag through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.

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 bag should not be used in more than one patient. This solution contains no preservative, unused contents should be discarded.

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

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BSS balanced salt solution SODIUM CHLORIDE SODIUM CATION POTASSIUM CHLORIDE POTASSIUM CATION CALCIUM CHLORIDE CALCIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION SODIUM ACETATE Sodium Cation SODIUM CITRATE SODIUM CATION SODIUM HYDROXIDE HYDROCHLORIC ACID WATER Overwrap Bag Label

NDA020742

BSS

balanced salt solution

0065-1795

HUMAN PRESCRIPTION DRUG

OPHTHALMIC

PRINCIPAL DISPLAY PANEL SINGLE PATIENT USE ONLY Rx Only NDC 0065-1795-04 BSS ™ Sterile Irrigating Solution (balanced salt solution) Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride •2H 2 O 0.048%, magnesium chloride •6H 2 O 0.03%, sodium acetate •3H 2 O 0.39%, sodium citrate •2H 2 O 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. NOT FOR I.V. USE Read accompanying insert. WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless outer overwrap is intact, product is clear, seal is intact and bag is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use this bag for more than one patient. STORAGE: Store at 36° - 77° F (2° - 25°C). STERILE 500 mL Alcon Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA LOT : EXP .: MFD .: 300048948-0521 Storage: Store at 36° - 77°F (2° - 25°C). Do not use unless outer overwrap is intact. 9012629-1115

HOW SUPPLIED: BSS ™ Sterile Irrigating Solution is supplied in a clear polypropylene bag using a grey butyl stopper and aluminum seal packaged in a clear, multilayered plastic outer overwrap. 500 mL in a bag: NDC 0065-1795-04. STORAGE: Store at 36° - 77°F (2° - 25°C). Alcon Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA © 2021 Alcon, Inc.

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.