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, S.A. Alcon-Couvreur N.V.. 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 bottle 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 or 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 firmly 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 LEURLOK® adapter plug with a white polypropylene closure) in a blister package.

15 mL in a 15 mL bottle:
NDC0065-0795-15

30 mL in a 30 mL bottle:
NDC0065-0795-30

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  
9012634-1115

PRINCIPAL DISPLAY PANEL

NDC 0065-0795-15

BSS®
Sterile Irrigating Solution
(balanced salt solution)

ALCON®
a Norvartis company

CONTENTS: 3 doz. 15mL Single Dose Bottles

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

Rx Only

Alcon®

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
© 2002, 2013, 2015 Novartis

9012635-1115

NDC 0065-0795-15

BSS®
Sterile Irrigating Solution
(balanced salt solution)

STERILE UNLESS PACKAGE OPEN OR BROKEN

15 mL DROP-TAINER® Bottle, SINGLE DOSE UNIT With Adapter for LUER-LOK® Hub Irrigating Needle

A sterile balanced salt solution for extraocular and intraocular use during procedures with an expected maximum duration of less than 60 minutes. Read enclosed insert.

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 blister or paper backing is damaged or broken.
Do not use if product is discolored or contains a precipitate.
SINGLE patient use only. The contents of this bottle 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.

Rx Only

Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.

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

NOTE: LUER-LOK is a registered trademark of Becton, Dickinson & Co.

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
©2003, 2013, 2015 Novartis

Alcon®
a Novartis company

9012632-1115

NDC 0065-0795-15

BSS®

STERILE IRRIGATING SOLUTION

(BALANCED SALT SOLUTION)

UNIT DOSE 15 mL

Rx Only

ALCON LABORATRIES, INC.
FORT WORTH
TEXAS 76134 USA

289010-0902

INGREDIENTS AND APPEARANCE

BSS 
balanced salt solution solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0065-0795
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: 0065-0795-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/1969
2	NDC: 0065-0795-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/1969	12/31/2018
3	NDC: 0065-0795-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/1969	04/17/2015
4	NDC: 0065-0795-50	500 mL in 1 BOTTLE; 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 LLC		007672236	manufacture(0065-0795)

Establishment
Name	Address	ID/FEI	Business Operations
S.A. Alcon-Couvreur N.V.		370205429	manufacture(0065-0795)