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.
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.
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...
Rx only
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. | ||
Balanced Salt Solution is an isotonic solution for use in irrigating tissues of the eyes.
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.
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.
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.
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:
NDC 17478-920-19 18 mL bottle
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 NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-920-19 | ML - Milliliter | 17478-920 | ff9b6c94-1346-41a8-b156-df8d6ea525df | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Calcium Chloride | ACTIVE INGREDIENT | M4I0D6VV5M | 5 | |
| Magnesium Chloride | ACTIVE INGREDIENT | 02F3473H9O | 5 | |
| Potassium Chloride | ACTIVE INGREDIENT | 660YQ98I10 | 5 | |
| Sodium Acetate | ACTIVE INGREDIENT | 4550K0SC9B | 5 | |
| Sodium Chloride | ACTIVE INGREDIENT | 451W47IQ8X | 5 | |
| Sodium Citrate | ACTIVE INGREDIENT | 1Q73Q2JULR | 5 | |
| calcium cation | ACTIVE MOIETY | 2M83C4R6ZB | 5 | |
| magnesium cation | ACTIVE MOIETY | T6V3LHY838 | 5 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | 5 | |
| SODIUM CATION | ACTIVE MOIETY | LYR4M0NH37 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 17478-920 | 17478-920-19 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Calcium Chloride | M4I0D6VV5M | ACTIB |
| Magnesium Chloride | 02F3473H9O | ACTIB |
| Potassium Chloride | 660YQ98I10 | ACTIB |
| Sodium Acetate | 4550K0SC9B | ACTIB |
| Sodium Chloride | 451W47IQ8X | ACTIB |
| Sodium Citrate | 1Q73Q2JULR | ACTIB |
| Hydrochloric Acid | QTT17582CB | IACT |
| Sodium Hydroxide | 55X04QC32I | IACT |
| Water | 059QF0KO0R | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075503-001 | BALANCED SALT | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | AT | 2006-09-27 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075503-001 | BALANCED SALT | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION / IRRIGATION | 2006-09-27 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075503-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075503-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075503-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075503-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075503-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075503-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075503-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075503-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075503-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075503-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075503-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075503-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075503-001 | AT | 1 | ea99ee380514… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075503-001 | AT | 1 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 07da8a73-08cc-4032-ac64-584348e55a43 | b691c782-98e8-4689-8ae3-e7bc30e46785 | 2022-05-20 | Warnings, Adverse reactions | b691c782-98e8-4689-8ae3-e7bc30e46785 |
Adverse event summaries are temporarily unavailable. Other product information remains available.