AKORN BALANCED SALT SOLUTION

Manufacturer
Akorn | Akorn Operating Company LLC
Effective date
2022-01-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:11:50

Label at a glance#

ProductBALANCED SALT
Active ingredientCalcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate
Label structure11 sections

Indications and uses

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

18 mL bottle: The adaptor plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the bottle as explained below. External irrigation may be done without the irrigating needle. Method for Using Adaptor Plug for Ophthalmic Irrigating Needle: Aseptically remove bottle from pouch by peeling backing. Snap on surgeon's sterile irrigation needle. Push until firmly in place. Te...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION

DESCRIPTION SECTION

BALANCED SALT SOLUTION is a sterile physiological solution containing calcium chloride (CaCl2·2H2O), magnesium chloride (MgCl2·6H2O), potassium chloride (KCl), sodium acetate (C2H3NaO2·3H2O), sodium chloride (NaCl) and sodium citrate (C6H5Na3O7·2H2O). This solution is isotonic to ocular tissue and contains electrolytes required for normal cellular metabolic functions. Each 1 mL contains:

Calcium Chloride (MW 147.02) 0.48 mg
Magnesium Chloride (MW 203.31) 0.30 mg
Potassium Chloride (MW 74.56) 0.75 mg
Sodium Acetate (MW 136.08) 3.90 mg
Sodium Chloride (MW 58.44) 6.40 mg
Sodium Citrate (MW 294.10) 1.70 mg
Hydrochloric Acid and/or Sodium Hydroxide added to adjust pH.
Water for Injection
7.0 pH and 300 mosm/kg osmolality.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Balanced Salt Solution is an isotonic solution for use in irrigating tissues of the eyes.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

  • NOT FOR INJECTION OR INTRAVENOUS INFUSION.
  • Do not use unless product is clear, seal is intact, 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

PRECAUTIONS SECTION

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 Balanced Salt Solution (Sterile Irrigating Solution) was used as an irrigating solution.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED SECTION

18 mL bottle: The adaptor plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the bottle as explained below. External irrigation may be done without the irrigating needle.

Method for Using Adaptor Plug for Ophthalmic Irrigating Needle:

  1. Aseptically remove bottle from pouch by peeling backing.
  2. Snap on surgeon's sterile irrigation needle. Push until firmly in place.
  3. Test assembly for proper function before use.

HOW SUPPLIED:

HOW SUPPLIED SECTION

NDC 17478-920-19 18 mL bottle

STORAGE AND HANDLING SECTION

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat and do not allow to freeze.

AKORN
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
BLA0N Rev. 10/16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-920-19 Akorn Logo

BALANCED

SALT SOLUTION

Rx only

NOT FOR INJECTION

OR INTRAVENOUS USE.

18 mL Sterile Single Dose Bottle

Principal Display Panel Text for Container Label
Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-920-19 Akorn Logo

BALANCED SALT SOLUTION

30 Sterile Single Dose Bottles (18 mL each)

NOT FOR INJECTION OR INTRAVENOUS USE.

Principal Display Panel Text for Carton Label
Principal Display Panel Text for Carton Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-920-19ML - Milliliter17478-920ff9b6c94-1346-41a8-b156-df8d6ea525df12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Calcium ChlorideACTIVE INGREDIENTM4I0D6VV5M5
Magnesium ChlorideACTIVE INGREDIENT02F3473H9O5
Potassium ChlorideACTIVE INGREDIENT660YQ98I105
Sodium AcetateACTIVE INGREDIENT4550K0SC9B5
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X5
Sodium CitrateACTIVE INGREDIENT1Q73Q2JULR5
calcium cationACTIVE MOIETY2M83C4R6ZB5
magnesium cationACTIVE MOIETYT6V3LHY8385
POTASSIUM CATIONACTIVE MOIETY295O53K1525
SODIUM CATIONACTIVE MOIETYLYR4M0NH375

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17478-92017478-920-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075503-001BALANCED SALTCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-2784e616aacf4f…
2026-08-18 06:07:402026-07A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-273f01610625f2…
2019-09-15 20:21 UTC2019-09A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONAT2006-09-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075503-001BALANCED SALT0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATION2006-09-27f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075503-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075503-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075503-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075503-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075503-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075503-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075503-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A075503-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075503-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075503-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075503-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A075503-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075503-001AT1ea99ee380514…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075503-001AT1cb3db0bc1861…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
07da8a73-08cc-4032-ac64-584348e55a43b691c782-98e8-4689-8ae3-e7bc30e467852022-05-20Warnings, Adverse reactionsExact identifier
spl set id: b691c782-98e8-4689-8ae3-e7bc30e46785

Reported adverse events (FAERS/openFDA)#

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