BSS
BSS is an FDA drug label for the active ingredient BALANCED SALT SOLUTION manufactured by Alcon Laboratories, Inc. administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231214.
- Generic name
- BALANCED SALT SOLUTION
- Manufacturer
- Alcon Laboratories, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- OPHTHALMIC
- Dosage form
- N/A
- NDC
- 0065-1795
- Application
- NDA020742
- Label effective
- 20231214
Indications & 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION: This irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Remove the outer overwrap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bag through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.
Contraindications
Not available.
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 bag should not be used in more than one patient. This solution contains no preservative, unused contents should be discarded.
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.