Label: BSS- balanced salt solution solution

  • NDC Code(s): 0065-0795-15, 0065-0795-25, 0065-0795-30, 0065-0795-50
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 23, 2020

If you are a consumer or patient please visit this version.

  • 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. 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:
    NDC0065-0795-15

    30 mL in a 30 mL bottle:
    NDC0065-0795-30

    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

    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

    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
  • INGREDIENTS AND APPEARANCE
    BSS 
    balanced salt solution solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0065-0795
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6.4 mg  in 1 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE0.75 mg  in 1 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE0.48 mg  in 1 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE0.3 mg  in 1 mL
    SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM ACETATE3.9 mg  in 1 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE1.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0795-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/1969
    2NDC:0065-0795-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/196912/31/2018
    3NDC:0065-0795-25250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/196904/17/2015
    4NDC:0065-0795-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/1969
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02074203/28/1969
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0795)
    Establishment
    NameAddressID/FEIBusiness Operations
    S.A. Alcon-Couvreur N.V.370205429manufacture(0065-0795)