BSS

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

cartonlabellabel

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 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:
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
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

carton
(click image for full-size original)

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

label
(click image for full-size original)

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

label
(click image for full-size original)
BSS balanced salt solution solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-0795
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:0065-0795-15 15 mL in 1 BOTTLE None
2 NDC:0065-0795-30 30 mL in 1 BOTTLE None
3 NDC:0065-0795-25 250 mL in 1 BOTTLE None
4 NDC:0065-0795-50 500 mL in 1 BOTTLE 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 (0065-0795)
Establishment
Name Address ID/FEI Operations
S.A. Alcon-Couvreur N.V. 370205429 manufacture (0065-0795)

Revised: 11/2021 Alcon Laboratories, Inc.

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