BSS: Package Insert and Label Information

BSS — sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and sodium citrate solution
Alcon Laboratories, Inc.

LabelOverwrap

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 (CaCl2 •2H2 O) 0.048%, magnesium chloride hexahydrate (MgCl2 •6H2 O) 0.03%, sodium acetate trihydrate (C2 H3 NaO2 •3H2 O) 0.39%, sodium citrate dihydrate (C6 H5 Na3 O7 •2H2 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.

CLINICAL PHARMACOLOGY:

BSS 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 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.

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.

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:

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.

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®
a Novartis company
Distributed by:
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
© 2012, 2015 Novartis

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 •2H2 O 0.048%, magnesium chloride •6H2 O 0.03%, sodium acetate •3H2 O 0.39%, sodium citrate •2H2 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
© 2012, 2015 Novartis
LOT:
EXP.:
MFD.:
9012630-1115

Label
(click image for full-size original)

Storage: Store at 36° — 77°F (2° — 25°C).
Do not use unless outer overwrap is intact.
9012629-1115

Overwrap
(click image for full-size original)
BSS balanced salt solution solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-1795
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 6.4 mg in 1 mL
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 0.75 mg in 1 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 0.48 mg in 1 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 0.3 mg in 1 mL
SODIUM ACETATE (Sodium Cation) SODIUM ACETATE 3.9 mg in 1 mL
SODIUM CITRATE (SODIUM CATION) SODIUM CITRATE 1.7 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0065-1795-04 500 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020742 03/28/1969
Labeler — Alcon Laboratories, Inc. (008018525)
Registrant — Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Research LLC 007672236 manufacture (0065-1795)

Revised: 11/2020 Alcon Laboratories, Inc.

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