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Bss Package Insert

Updated:
Facts
Status:
Prescription (Rx)
Strength:
6.4 mg/mL, 0.75 mg/mL, 0.48 mg/mL, 0.3 mg/mL, 3.9 mg/mL, 1.7 mg/mL
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Bss

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.

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. 1. Aseptically remove DROP-TAINER bottle from blister by peeling paper backing.
  2. 2. Snap on surgeon's sterile irrigation needle. Push until firmly in place and twist slightly.
  3. 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 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

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 020742 · View the label on DailyMed

Revision date stated in the text: May 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Bss

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative, Phosphate Binder, Potassium Salt
Active ingredients Sodium chloride 6.4 mg/mL, Potassium chloride 0.75 mg/mL, Calcium chloride 0.48 mg/mL, Magnesium chloride 0.3 mg/mL, Sodium acetate 3.9 mg/mL, Sodium citrate 1.7 mg/mL
Dosage form Solution
Route Ophthalmic
Marketing status listed in the FDA NDC Directory
Company (applicant) ALCON
FDA approval NDA 020742New Drug Application (NDA) Approved December 10, 1997
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ATCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
6.4 mg/mL, 0.75 mg/mL, 0.48 mg/mL, 0.3 mg/mL, 3.9 mg/mL, 1.7 mg/mL – 15 ml in 1 bottle NDC 0065-0795-15
6.4 mg/mL, 0.75 mg/mL, 0.48 mg/mL, 0.3 mg/mL, 3.9 mg/mL, 1.7 mg/mL – 30 ml in 1 bottle NDC 0065-0795-30
6.4 mg/mL, 0.75 mg/mL, 0.48 mg/mL, 0.3 mg/mL, 3.9 mg/mL, 1.7 mg/mL – 250 ml in 1 bottle NDC 0065-0795-25
6.4 mg/mL, 0.75 mg/mL, 0.48 mg/mL, 0.3 mg/mL, 3.9 mg/mL, 1.7 mg/mL – 500 ml in 1 bottle NDC 0065-0795-50

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.