Label: BSS- balanced salt solution solution

  • NDC Code(s): 0065-1795-04
  • 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 bag 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.

    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:

    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:

    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.

  • HOW SUPPLIED:

    BSS® Sterile Irrigating Solution is supplied in a clear polypropylene bag using a grey butyl stopper and aluminum seal packaged in a clear, multilayered plastic outer overwrap.
    500 mL in a bag: NDC 0065-1795-04.

    STORAGE:  Store at 36° - 77°F (2° - 25°C).

    Alcon®
    a Novartis company

    Distributed by:
    Alcon Laboratories, Inc.
    Fort Worth, Texas 76134 USA
    © 2012, 2015 Novartis

  • PRINCIPAL DISPLAY PANEL

    SINGLE PATIENT USE ONLY

    Rx Only

    NDC 0065-1795-04

    BSS®
    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.

    NOT FOR I.V. USE

    Read accompanying insert.

    WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless outer overwrap is intact, product is clear, seal is intact and bag is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use this bag for more than one patient.
    STORAGE: Store at 36° - 77° F (2° - 25°C).

    STERILE        500 mL

    Alcon®

    Alcon Laboratories, Inc.
    Fort Worth, Texas 76134 USA

    © 2012, 2015 Novartis

    LOT:
    EXP.:
    MFD.:

    9012630-1115

    Label

    Storage: Store at 36° - 77°F (2° - 25°C).

    Do not use unless outer overwrap is intact.

    9012629-1115

    Overwrap
  • INGREDIENTS AND APPEARANCE
    BSS  
    balanced salt solution solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0065-1795
    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:0065-1795-04500 mL in 1 BAG; 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(0065-1795)