BSS — Solution

Overview

Brand name

BSS

Generic name

balanced salt solution

Dosage form

Solution

Route

Ophthalmic

Marketing category

NDA · NDA

Labeler

Alcon Laboratories, Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

6

NDC product codes

2

Packages

3

Data completeness

77% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Calcium Chloride	.48 mg/mL	828525	View
Magnesium Chloride	.3 mg/mL	799999	View
Potassium Chloride	.75 mg/mL	628953	View
Sodium Acetate	3.9 mg/mL	312965	View
Sodium Chloride	6.4 mg/mL	707251	View
Sodium Citrate	1.7 mg/mL	543014	—

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

Route of administration

Ophthalmic

Presentations

5

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Blood Coagulation Factor [EPC]	EPC	All 23 members
Calcium [CS]	CS	All 23 members
Calculi Dissolution Agent [EPC]	EPC	All 33 members
Cations	EPC	All 23 members
Divalent [CS]	CS	All 23 members
Increased Coagulation Factor Activity [PE]	PE	All 23 members
Increased Large Intestinal Motility [PE]	PE	All 83 members
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]	PE	All 83 members
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]	PE	All 30 members
Magnesium Ion Exchange Activity [MoA]	MoA	All 30 members
Osmotic Activity [MoA]	MoA	All 105 members
Osmotic Laxative [EPC]	EPC	All 103 members
Phosphate Binder [EPC]	EPC	All 42 members
Phosphate Chelating Activity [MoA]	MoA	All 42 members
Potassium Compounds [CS]	CS	All 49 members
Potassium Salt [EPC]	EPC	All 49 members
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]	PE	All 53 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

020742

Application type

NDA · New Drug Application

Approval date

December 10, 1997

Sponsor

ALCON

Products on application

1

Submissions recorded

11

Products approved under application 020742.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
020742-001	BSS	SOLUTION		CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	Prescription	AT	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

AT

Reference Listed Drug

Yes

Reference Standard

Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 020742.
Type	No.	Action	Status	Date	Review
Supplement	26	Manufacturing (CMC)	Approved	November 6, 2015	Standard
Supplement	25	Labeling	Approved	November 6, 2015	Standard
Supplement	24	Manufacturing (CMC)	Approved	November 15, 2012	Standard
Supplement	20	Manufacturing (CMC)	Approved	April 23, 2009	Standard
Supplement	8	Labeling	Approved	September 30, 2004	Standard
Supplement	6	Manufacturing (CMC)	Approved	May 25, 2004	Standard
Supplement	5	Labeling	Approved	May 25, 2004	Standard
Supplement	3	Labeling	Approved	July 9, 2003	Standard
Supplement	4	Manufacturing (CMC)	Approved	April 15, 2003	Standard
Supplement	1	Manufacturing (CMC)	Approved	October 30, 2002	Standard
Original application	1	Type 4 - New Combination	Approved	December 10, 1997	Standard

Review documents

0 · Supplement · December 22, 2015
0 · Supplement · December 22, 2015
0 · Supplement · November 12, 2015
0 · Supplement · November 12, 2015
0 · Supplement · April 29, 2009
0 · Supplement · October 4, 2004
0 · Supplement · October 4, 2004
0 · Supplement · May 27, 2004
0 · Supplement · May 27, 2004
0 · Supplement · May 26, 2004
0 · Supplement · May 26, 2004
0 · Supplement · July 10, 2003
0 · Supplement · July 10, 2003
0 · Supplement · May 29, 2003
0 · Supplement · April 28, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240125). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20240125 HUMAN PRESCRIPTION DRUG · 20231214

Indications and Usage

openFDA Drug Labeling

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 and Administration

openFDA Drug Labeling

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.

Warnings

openFDA Drug Labeling

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.

Adverse Reactions

openFDA Drug Labeling

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.

Description

openFDA Drug Labeling

DESCRIPTION: BSS TM 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 (CaCl 2 •2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 •6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 •3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 •2H 2 O) 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.

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED In 15 mL and 30 mL sterile DROP-TAINER bottles (consisting of a polypropylene bottle and LEUR-LOK TM adapter plug with a white polypropylene closure) in a blister package. 15 mL in a 15 mL bottle: NDC 0065-0795-15 30 mL in a 30 mL bottle: NDC 0065-0795-30 STORAGE: Store at 36° - 77°F (2° - 25°C). Revised: May 2021 Alcon Distributed by: Alcon Laboratories , Inc. 6201 South Freeway Fort Worth, Texas 76134 USA © 2021 Alcon Inc. W300048945-0521

Adverse event reports

Source: openFDA FAERS

271,787

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SODIUM CHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement

Drug recall enforcement reports associated with this product.
Classification	Reported	Firm	Reason	Status
Class II	June 15, 2022	Mckesson Medical-Surgical Inc. Corporate Office	cGMP deviations: Temperature abuse	Terminated
Class II	June 15, 2022	Mckesson Medical-Surgical Inc. Corporate Office	cGMP deviations: Temperature abuse	Terminated

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
0065-0795-15	0065-0795	Alcon Laboratories, Inc.	15 mL in 1 BOTTLE (0065-0795-15)	March 28, 1969
0065-0795-50	0065-0795	Alcon Laboratories, Inc.	500 mL in 1 BOTTLE (0065-0795-50)	March 28, 1969
0065-1795-04	0065-1795	Alcon Laboratories, Inc.	500 mL in 1 BAG (0065-1795-04)	March 28, 1969
0065-0795	0065-0795	Alcon Laboratories, Inc.	—	March 28, 1969
0065-1795	0065-1795	Alcon Laboratories, Inc.	—	March 28, 1969

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts
Enforcement	FDA	Recall records

Generated September 25, 2026 · 12 sections on this page.