BSS- balanced salt solution solution

BSS by

Drug Labeling and Warnings

BSS by is a Prescription medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (CaCl22H2O) 0.048%, magnesium chloride hexahydrate (MgCl26H2O) 0.03%, sodium acetate trihydrate (C2H3NaO23H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O72H2O) 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.
Prior to use, check the following: tip should be firmly in place, irrigating needle should be properly seated; squeeze out several drops before inserting into anterior chamber. The needle should be removed from the anterior chamber prior to releasing pressure to prevent suction.

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

The adapter plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the DROP-TAINER® bottle as explained below. External irrigation may be done without the irrigating needle.

Method of using Adapter Plug for LUER-LOK® Hub Ophthalmic Irrigating Needle:

1. Aseptically remove DROP-TAINER bottle from blister by peeling paper backing.
2. Snap on surgeon’s sterile irrigation needle. Push until rmly in place and twist slightly.
3. Test assembly for proper function before use.

NOTE: LUER-LOK is a registered trademark of Becton, Dickinson and Company.

HOW SUPPLIED

In 15 mL and 30 mL sterile DROP-TAINER® bottles (consisting of a polypropylene bottle and LUER-LOK® adapter plug with a white polypropylene closure) in a blister package.

15 mL in a 15 mL bottle:
NDC: 0065-0795-15  
30 mL in a 30 mL bottle
NDC: 0065-0795-30

STORAGE:Store at 36°-77°F (2°-25°C).

Revised: November 2015

Alcon®
A Novartis company

Distributed by:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA

©2000-2003, 2015 Novartis

W9012634-1115

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 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 7.5. 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

Storage: Store at 36° - 77°F (2° - 25°C).

Do not use unless outer overwrap is intact.

9012629-1115

INGREDIENTS AND APPEARANCE

BSS  
balanced salt solution solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0065-1795
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6.4 mg  in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	0.75 mg  in 1 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CHLORIDE	0.48 mg  in 1 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CHLORIDE	0.3 mg  in 1 mL
SODIUM ACETATE (UNII: 4550K0SC9B) (Sodium Cation - UNII:LYR4M0NH37)	SODIUM ACETATE	3.9 mg  in 1 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CITRATE	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: 0065-1795-04	500 mL in 1 BAG; Type 0: Not a Combination Product	03/28/1969

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	Business Operations
Alcon Research Ltd		007672236	MANUFACTURE(0065-1795)