BSS PLUS

Manufacturer: Alcon Laboratories, Inc. | Alcon Research LLC
Effective date: 2024-01-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-05-31 20:58:48

Label at a glance#

ProductBSS PLUS

Active ingredientSodium Chloride, Potassium Chloride, Sodium Phosphate, Dibasic, Unspecified Form, Sodium Bicarbonate, Calcium Chloride, Magnesium Chloride, Dextrose, Unspecified Form, Oxiglutatione

Label structure13 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

DESCRIPTION: BSS PLUS^® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.

Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bottle to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.

After addition of BSS PLUS Part II to the Part I bottle, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm.

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

None of the components of BSS PLUS are foreign to the eye. Human perfused cornea studies have shown BSS PLUS to be an effective irrigation solution for providing corneal detumescence and maintaining corneal endothelial integrity during intraocular perfusion. An in vivo study in rabbits has shown that BSS PLUS is more suitable than normal saline or Balanced Salt Solution for intravitreal irrigation because BSS PLUS contains the appropriate bicarbonate, pH, and ionic composition necessary for the maintenance of normal retinal electrical activity. Human in vivo studies have demonstrated BSS PLUS to be safe and effective when used during surgical procedures such as pars plana vitrectomy, phacoemulsification, cataract extraction/lens aspiration, anterior segment reconstruction. No differences have been observed between adults and pediatric patients following use of this drug product.

INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE: BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

CONTRAINDICATIONS SECTION

CONTRAINDICATIONS: There are no specific contraindications to the use of BSS PLUS; however, contraindications for the surgical procedure during which BSS PLUS is to be used should be strictly adhered to.

WARNINGS SECTION

WARNINGS: For IRRIGATION during ophthalmic surgery only. 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.

PRECAUTIONS SECTION

PRECAUTIONS: DO NOT USE BSS PLUS UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS does not contain a preservative; therefore, do not use this container for more than one patient. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. 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 PLUS was used as an irrigating solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

SPL UNCLASSIFIED SECTION

Preparation: Reconstitute BSS PLUS^® Intraocular Irrigating Solution just prior to use in surgery. Follow the same strict aseptic procedures in the reconstitution of BSS PLUS as is used for intravenous additives. Remove the blue flip-off seal from the BSS PLUS Part I (480 mL) bottle. Remove the blue flip-off seal from the BSS PLUS Part II (20 mL) vial. Clean and disinfect the rubber stoppers on both containers by using sterile alcohol wipes. Transfer the contents of the Part II vial to the Part I bottle using a BSS PLUS Vacuum Transfer Device (provided). An alternative method of solution transfer may be accomplished by using a 20 mL syringe to remove the Part II solution from the vial and transferring exactly 20 mL to the Part I container through the outer target area of the rubber stopper. An excess volume of Part II is provided in each vial. Gently agitate the contents to mix the solution. Place a sterile cap on the bottle. Remove the tear-off portion of the label. Record the time and date of reconstitution and the patient's name on the bottle label.

GERIATRIC USE SECTION

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS SECTION

ADVERSE REACTIONS: Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the use of BSS PLUS has not been established.

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION: The solution should be used according to the standard technique employed by the operating surgeon. Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow the directions for the particular administration set to be used. Insert the spike aseptically into the bottle through the center target area of the rubber stopper. Allow the fluid to flow to remove air from the tubing before intraocular irrigation begins. If a second bottle is necessary to complete the surgical procedure, ensure that the vacuum is vented from the second bottle BEFORE attachment to the administration set.

HOW SUPPLIED SECTION

HOW SUPPLIED: BSS PLUS is supplied in two packages for reconstitution prior to use: a 500 mL glass bottle containing 480 mL (Part I) and a 20 mL glass vial (Part II); both using grey butyl stoppers and aluminum seals with polypropylene flip-off caps. See the PRECAUTIONS section regarding reconstitution of the solution.

NDC 0065-0800-50.

Storage: Store Part I and Part II at 2˚C to 25˚C (36°F to 77° F). Discard prepared solution after six hours.

Alcon

Distributed by:
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
©2023 Alcon, Inc.

Revised: April 2023

W300049014-0521

INSTRUCTIONS FOR USE SECTION

RECONSTITUTION INSTRUCTIONS

DIRECTIONS: Use Aseptic Technique

Remove the blue flip-off seal from the BSS PLUS^® Part I (480 mL) bottle. Remove the blue flip-off seal from the BSS PLUS Part II (20 mL) vial. Prepare the stoppers on both parts by using sterile alcohol wipes.
Peel open a BSS PLUS Vacuum Transfer Device package (supplied) and remove the sterile transfer spike.

NOTE: This device is vented permitting air to enter vial during solution transfer, thereby preventing the creation of a vacuum inside the vial. An air-inlet filter is provided to protect the system. Do not remove the air-inlet filter.
Remove protector from the white plastic piercing pin.
Firmly grasp device from behind the flange and insert the white plastic piercing pin into the upright rubber stopper of the BSS PLUS Part II (20 mL) vial.
Remove guard from filter needle. Firmly grasp vial in the palm of one hand and with thumb and index finger, hold plastic flange against top of vial.
Invert vial and immediately insert filter needle into the outer target of the rubber stopper of the BSS PLUS Part I (480 mL) bottle. (See illustration.)
Fluid will automatically transfer from the vial into the large vacuum bottle unless filter becomes occluded or loss of vacuum occurs. NOTE: An excess amount of BSS PLUS Part II is provided in each vial. A non-transferred solution residual of approximately 0.3 mL can be expected to remain in the vial.
Immediately remove needle from the BSS PLUS Part I container and discard it after solution transfer has been completed.
Place a sterile safety cap over the rubber stopper of Part I if the solution is not going to be used immediately. Mix the solution gently until uniform. Peel off the right-hand side of Part I bottle label (fully reconstituted BSS PLUS Solution). Record the patient’s name and the date and time of reconstitution. BSS PLUS Solution is now ready for use.

CAUTION: Reconstituted BSS PLUS Solution must be used within six hours of mixing. Discard any solution which has aged beyond that time. Never use the same bottle of BSS PLUS Solution on more than one patient.

Alternative Transfer Method
If preferred, the contents of the BSS PLUS Part II component may be aspirated with an 18-gauge cannula attached to a 20 mL syringe and then transferred into the Part I bottle.

Alcon

Distributed by:
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA

Revised: April 2023

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0065-0800-50

500 mL
Single Patient Use

BSS PLUS^™
STERILE INTRAOCULAR IRRIGATING SOLUTION
(balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

After addition of BSS PLUS^™– Part II (20 mL), each mL contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

pH Approx. 7.4 – Osmolality Approx. 305 mOsm/kg

Rx Only

WARNINGS: FOR IRRIGATION DURING OPHTHALMIC SURGERY ONLY. 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.

PRECAUTIONS: DO NOT USE BSS PLUS UNTIL PART I IS FULLY RECONSTITUTED WITH PART II.
                               DISCARD UNUSED CONTENTS SIX HOURS AFTER PREPARATION.
                               DO NOT USE THIS CONTAINER FOR MORE THAN ONE PATIENT.

Reconstitute just prior to use in surgery.

Alcon

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA

Patient_____________________
Reconstituted at _________________      AM/PM on_________________

LOT:
EXP.:

SINGLE USE ONLY

NDC 0065-0800-50
480 mL

BSS PLUS™ PART I
STERILE SOLUTION
(For Reconstitution by Addition of BSS PLUS ^TM Concentrate Part II, 20 mL)*

Each mL contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

Rx Only

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

WARNINGS: FOR IRRIGATION DURING OPHTHALMIC SURGERY ONLY AFTER RECONSTITUTION. DO NOT USE UNLESS PRODUCT IS CLEAR, SEAL IS INTACT, VACUUM IS PRESENT AND CONTAINER IS UNDAMAGED.

NOT FOR INJECTION OR INTRAVENOUS INFUSION

*Reconstitute just prior to use in surgery. Remove this part of label after reconstitution. Read the Preparation and Administration sections of the package insert before reconstitution for important directions and precautions.

300048951-0521

NDC 0065-0800-50

500 mL
Single Patient Use

BSS PLUS^®
STERILE INTRAOCULAR IRRIGATING SOLUTION
(balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

After addition of BSS PLUS^®– Part II (20 mL), each mL contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

pH Approx. 7.4 – Osmolality Approx. 305 mOsm/kg

Rx Only

WARNINGS: FOR IRRIGATION DURING OPHTHALMIC SURGERY ONLY. 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.

PRECAUTIONS: DO NOT USE BSS PLUS UNTIL PART I IS FULLY RECONSTITUTED WITH PART II.
                               DISCARD UNUSED CONTENTS SIX HOURS AFTER PREPARATION.
                               DO NOT USE THIS CONTAINER FOR MORE THAN ONE PATIENT.

Reconstitute just prior to use in surgery.

Alcon^®
a Novartis company

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
©2002-2003, 2015 Novartis

Patient_____________________
Reconstituted at _________________      AM/PM on_________________

LOT:
EXP.:

SINGLE USE ONLY

NDC 0065-0800-50
480 mL

BSS PLUS^® PART I
STERILE SOLUTION
(For Reconstitution by Addition of BSS PLUS^® Concentrate Part II, 20 mL)*

Each mL contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

Rx Only

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

WARNINGS: FOR IRRIGATION DURING OPHTHALMIC SURGERY ONLY AFTER RECONSTITUTION. DO NOT USE UNLESS PRODUCT IS CLEAR, SEAL IS INTACT, VACUUM IS PRESENT AND CONTAINER IS UNDAMAGED.

NOT FOR INJECTION OR INTRAVENOUS INFUSION

*Reconstitute just prior to use in surgery. Remove this part of label after reconstitution. Read the Preparation and Administration sections of the package insert before reconstitution for important directions and precautions.

H14138-1115

NDC 0065-0800-50

20 mL

BSS PLUS^®
CONCENTRATE PART II
(Sterile Solution for Reconstitution)

Alcon^®
Alcon Laboratories Inc.
Fort Worth, Texas 76134 USA

Each mL contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.

For Addition to BSS PLUS^® — Part I (480 mL) only.

See Preparation section of package insert.

WARNINGS: Not for injection or intravenous infusion – for reconstitution of irrigation solution only. 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.

PRECAUTIONS: Discard unused contents. Do not use this container for more than one patient.

Storage: Store at 2°-25°C (36°-77°F).

Rx Only

©2002-2003, 2015 Novartis

H14142-1115

LOT:

EXP.:

NDC 0065-0800-50

20 mL

BSS PLUS^®
CONCENTRATE PART II
(Sterile Solution for Reconstitution)

Alcon^®
Alcon Laboratories Inc.
Fort Worth, Texas 76134 USA

Each mL contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.

For Addition to BSS PLUS^® — Part I (480 mL) only.

See Preparation section of package insert.

WARNINGS: Not for injection or intravenous infusion – for reconstitution of irrigation solution only. 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.

PRECAUTIONS: Discard unused contents. Do not use this container for more than one patient.

Storage: Store at 2°-25°C (36°-77°F).

Rx Only

©2002-2003, 2015 Novartis

H14142-1115

LOT:

EXP.:

BSS Plus^™
STERILE IRRIGATING SOLUTION
(balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

Carton Contents:

1 Vial BSS PLUS^™ Concentrate Part II Sterile Solution for Reconstitution with BSS PLUS Part I Only
1 BSS PLUS Vacuum Transfer Device
1 BSS PLUS Product Package Insert

WARNINGS: For IRRIGATION during ophthalmic surgery only. 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.

Store at 2°-35°C (36°-77°F).
Discard prepared solution after six hours.

Alcon

Alcon Laboratories Inc. Fort Worth, Texas 76134 USA

PRECAUTIONS: DO NOT USE BSS PLUS^™ solution UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS does not contain a preservative; therefore, do not use this container for more than one patient. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. 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 PLUS solution was used as an irrigating solutions. As in all surgical procedures, appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

LOT:
EXP:

300049013-0521

BSS Plus™
STERILE IRRIGATING SOLUTION
(balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

Carton Contents:

1 Vial BSS PLUS^® Concentrate Part II Sterile Solution for Reconstitution with BSS PLUS Part I Only
1 BSS PLUS Vacuum Transfer Device
1 BSS PLUS Product Package Insert

WARNINGS: For IRRIGATION during ophthalmic surgery only. 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.

Stare at 2°-35°C (36°-77°F).
Discard prepared solution after six hours.

Alcon^®
a Novartis company

Alcon Laboratories Inc. Fort Worth, Texas 76134 USA
© 2002, 2013, 2015 Novartis

PRECAUTIONS: DO NOT USE BSS PLUS^® solution UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS does not contain a preservative; therefore, do not use this container for more than one patient. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. 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 PLUS solution was used as an irrigating solutions. As in all surgical procedures, appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

LOT:
EXP:

9012435-0116

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CALCIUM CATION Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20230427
MAGNESIUM CATION Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20180813
POTASSIUM CATION Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
SODIUM CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0065-0800-50	BSS PLUS	1 in 1 PACKAGE	KIT	1		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0800	BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]	11	Current NDC, Legacy NDC, 1 package rows	20240126_f69655c5-cf32-6461-e00e-3a5c4a761344.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0800-25	ML - Milliliter	0065-0800	ea2b9bf3-a0ef-4a7e-9a07-fb816e4907a3	1	2012-07-24
0065-0800-50	ML - Milliliter	0065-0800	723c3934-6d6c-4581-a79e-e7b2cbc90a15	1	2012-07-24
0065-0800-94	ML - Milliliter	0065-0800	f4150100-1180-4551-a1b3-fe1455c0be91	1	2016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Calcium Chloride	ACTIVE INGREDIENT	M4I0D6VV5M	1
Dextrose	ACTIVE INGREDIENT	IY9XDZ35W2	1
Magnesium Chloride	ACTIVE INGREDIENT	02F3473H9O	1
Oxiglutatione	ACTIVE INGREDIENT	ULW86O013H	1
Potassium Chloride	ACTIVE INGREDIENT	660YQ98I10	1
Sodium Bicarbonate	ACTIVE INGREDIENT	8MDF5V39QO	1
Sodium Chloride	ACTIVE INGREDIENT	451W47IQ8X	1
Sodium Phosphate, Dibasic	ACTIVE INGREDIENT	GR686LBA74	1
Calcium Cation	ACTIVE MOIETY	2M83C4R6ZB	1
Dextrose	ACTIVE MOIETY	IY9XDZ35W2	1
Glutathione	ACTIVE MOIETY	GAN16C9B8O	1
Magnesium Cation	ACTIVE MOIETY	T6V3LHY838	1
Potassium Cation	ACTIVE MOIETY	295O53K152	1
Sodium Cation	ACTIVE MOIETY	LYR4M0NH37	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

BSS PLUS
balanced salt solution enriched with bicarbonate, dextrose, and glutathione
Part 1
Sodium Chloride
Sodium Cation
Potassium Chloride
Potassium Cation
Sodium Phosphate, Dibasic, Unspecified Form
Sodium Bicarbonate
Hydrochloric Acid
Sodium Hydroxide
Water
Part II
calcium chloride, magnesium chloride, dextrose, and glutathione
Calcium Chloride
Calcium Cation
Magnesium Chloride
Magnesium Cation
Dextrose, Unspecified Form
Anhydrous Dextrose
Oxiglutatione

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0065-0800	0065-0800-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Chloride	451W47IQ8X	ACTIB
Potassium Chloride	660YQ98I10	ACTIB
Sodium Phosphate, Dibasic, Unspecified Form	GR686LBA74	ACTIB
Sodium Bicarbonate	8MDF5V39QO	ACTIB
Hydrochloric Acid	QTT17582CB	IACT
Sodium Hydroxide	55X04QC32I	IACT
Water	059QF0KO0R	IACT
Calcium Chloride	M4I0D6VV5M	ACTIB
Magnesium Chloride	02F3473H9O	ACTIB
Dextrose, Unspecified Form	IY9XDZ35W2	ACTIB
Oxiglutatione	ULW86O013H	ACTIB
Water	059QF0KO0R	IACT

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018469-001	BSS PLUS	CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION		RLD, RS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BSS PLUS	BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE	Alcon Laboratories, Inc.	9b6d7322-4a90-b31e-9fbb-f1fba1343608	2024-01-25	Warnings, Adverse reactions	Exact identifier ndc (product): 0065-0800
BSS PLUS	BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE	Alcon Laboratories, Inc.	f69655c5-cf32-6461-e00e-3a5c4a761344	2024-01-25	Warnings, Adverse reactions	Exact identifier ndc (package): 0065-0800-50 ndc (product): 0065-0800 ndc11 (package): 00065080050 spl id: c86575ef-2310-4905-a681-52e3ee3aba87 spl set id: f69655c5-cf32-6461-e00e-3a5c4a761344

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.