Bss™

Bss™
SPL v15
SPL
SPL Set ID 4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea
Route
OPHTHALMIC
Published
Effective Date 2023-05-10
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (6.4 mg) Potassium Cation (0.75 mg) Calcium Cation (0.48 mg) Magnesium Cation (0.3 mg)
Inactive Ingredients
Sodium Hydroxide Hydrochloric Acid Water

Identifiers & Packaging

Marketing Status
NDA Active Since 1969-03-28 Until 2018-02-28

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.

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.

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.

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.

How Supplied

In 15 mL and 30 mL sterile DROP-TAINER bottles (consisting of a polypropylene bottle and LEUR-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: May 2021 Alcon Distributed by: Alcon Laboratories , Inc. 6201 South Freeway Fort Worth, Texas 76134 USA © 2021 Alcon Inc. W300048945-0521


Medication Information

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.

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.

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.

How Supplied

In 15 mL and 30 mL sterile DROP-TAINER bottles (consisting of a polypropylene bottle and LEUR-LOK 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: May 2021

Alcon

Distributed by:

Alcon Laboratories , Inc.

6201 South Freeway

Fort Worth, Texas 76134 USA

© 2021 Alcon Inc.

W300048945-0521

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•2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2•6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2•3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7•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.

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.

Clinical Pharmacology

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

Principal Display Panel

NDC 0065-0795-15



BSS™

Sterile Irrigating Solution

(balanced salt solution)



ALCON



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



300048944-0521

NDC 0065-0795-15



BSS®

Sterile Irrigating Solution

(balanced salt solution)



ALCON®

a Novartis 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 INTRAVENOUSINFUSION.

• 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



Alcon



9017036-0119

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


Structured Label Content

Warnings (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.

Description (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•2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2•6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2•3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7•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.

Precautions (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.

How Supplied (HOW SUPPLIED)

In 15 mL and 30 mL sterile DROP-TAINER bottles (consisting of a polypropylene bottle and LEUR-LOK 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: May 2021

Alcon

Distributed by:

Alcon Laboratories , Inc.

6201 South Freeway

Fort Worth, Texas 76134 USA

© 2021 Alcon Inc.

W300048945-0521

Adverse Reactions (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.

Clinical Pharmacology (CLINICAL PHARMACOLOGY)

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

Indications and Usage (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0065-0795-15



BSS™

Sterile Irrigating Solution

(balanced salt solution)



ALCON



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



300048944-0521

NDC 0065-0795-15



BSS®

Sterile Irrigating Solution

(balanced salt solution)



ALCON®

a Novartis 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 INTRAVENOUSINFUSION.

• 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



Alcon



9017036-0119

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

Dosage and Administration (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.


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