Label: BSS- balanced salt solution solution
- NDC Code(s): 0065-0795-25, 0065-0795-50
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated January 28, 2016
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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
- INDICATIONS AND USAGE
• NOT FOR INJECTION OR INTRAVENOUS INFUSION.
• Do not use unless product is clear, seal is intact, vacuum is present 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.
Open under aseptic conditions only.
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 and edema following ocular surgery in which BSS Sterile Irrigating Solution was used as an irrigating solution.
- ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
This irrigating solution should be used according to standard format for each surgical procedure. Note: Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow directions of the particular administration set to be used. Remove the blue flip-off cap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.
BSS® Sterile Irrigating Solution is supplied in a glass bottle using a grey butyl stopper and aluminum seal with a blue polypropylene flip-off cap.
250 mL in a 325 mL container: NDC 0065-0795-25.
500 mL in a 635 mL container: NDC 0065-0795-50.
STORAGE: Store at 36° - 77° F (2° - 25°C).
A Novartis company
Alcon Laboratories, Inc.
Fort Worth, Texas 76134
© 2000-2003, 2015 Novartis
PRINCIPAL DISPLAY PANEL
Sterile Irrigating Solution
(balanced salt solution)
Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride •2H2O 0.048%, magnesium chloride •6H2O 0.03%, sodium acetate •3H2O 0.39%, sodium citrate •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.
STERILE 500 mL
NOT FOR I.V. USE
SINGLE DOSE UNIT
Read accompanying insert.
WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use this container for more than one patient.
STORAGE: Store at 36°- 77°F (2°- 25°C).
a Novartis company
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
© 2001-2003, 2015 Novartis
SINGLE USE ONLY
INGREDIENTS AND APPEARANCE
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:0065-0795-25 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/28/1969 02/28/2018 2 NDC:0065-0795-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 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 Ltd 007672236 MANUFACTURE(0065-0795)