BSS BALANCED SALT ALCON LABORATORIES, INC. FDA Approved 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.

BSS

Generic: BALANCED SALT
FunFoxMeds box
Substance Calcium Chloride
Route
OPHTHALMIC
Applications
NDA020742
Package NDC

Drug Facts

Composition & Profile

Strengths
500 ml
Quantities
500 ml
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
M4I0D6VV5M 02F3473H9O 660YQ98I10 4550K0SC9B 451W47IQ8X 1Q73Q2JULR
Packaging

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.; 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

Package Descriptions
  • 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.
  • 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

Overview

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.

Indications & 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.

Dosage & 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 & Precautions
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.
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.


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