Indications and uses
For irrigation only. Not for injection.
For irrigation only. Not for injection.
As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.
Sterile Water for Irrigation, USP
Prepared by distillation. No antimicrobial agent or other substance has been added. pH 5.5 (5.0 to 7.0). Osmolarity 0 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.
For irrigation only. Not for injection.
This solution is not isotonic and is hemolytic.
As directed by a physician.
Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.
Recommended storage: Room temperature (25°C). Avoid excessive heat.

2F7112
NDC 0338-0004-02
250 mL
Baxter Logo
Not for Injection
For Irrigation Only
Sterile Water for
Irrigation, USP
Prepared by distillation. No antimicrobial
agent or other substance has been added.
pH 5.5 (5.0 to 7.0). Osmolarity 0 mOsmol/L
(calc.). Sterile, nonpyrogenic. Pour Bottle.
Warning: This solution is not isotonic and is
hemolytic. Dosage and Administration: As
directed by a physician. Cautions: Warm in
oven to not more than 50°C for a maximum
of 60 days. Discard after 60 days of warming.
Do not use unless solution is clear and seal
is intact. Discard unused portion. Rx only.
Recommended storage: Room temperature
(25°C). Avoid excessive heat.
PL 325 plastic
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA
07-09-64-068
Bar Code Position Only*
303380004027
LOT
EXP

Sterile Water for
Irrigation, USP
Pour Bottle
NDC 0338-0004-02
2F7112
EXP JUN 08
LOT # G012345
250 mL
Qty
24
Bar Code
(01)50303380004022(17)080630(10)G012345
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0004-02 | ML - Milliliter | 0338-0004 | 97a1a26a-8bbb-4cad-8455-fae5ff1747e3 | 1 | 2012-07-24 |
| 0338-0004-03 | ML - Milliliter | 0338-0004 | b8f88bb5-7ea5-4093-8e7b-89e5f3af2f7b | 1 | 2013-02-13 |
| 0338-0004-04 | ML - Milliliter | 0338-0004 | 24fbca35-41e2-431e-97e2-19f0ca2b522c | 1 | 2012-07-24 |
| 0338-0004-05 | ML - Milliliter | 0338-0004 | 1ed29dd4-04b1-43e5-874f-62b19ba6b642 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| WATER | ACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| WATER | ACTIVE MOIETY | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0338-0004 | 0338-0004-02, 0338-0004-03, 0338-0004-04, 0338-0004-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| N017428-001 | STERILE WATER | STERILE WATER FOR IRRIGATION | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 |
| Application-product | TE code |
|---|---|
| N017428-001 | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | Approved before 1982 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017428-001 | STERILE WATER | 100% | LIQUID / IRRIGATION | AT | RLD, Approved before 1982 | 3a93d1ddd44b… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N017428-001 | AT | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N017428-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N017428-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N017428-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017428-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N017428-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017428-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017428-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017428-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017428-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017428-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017428-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N017428-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017428-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017428-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017428-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N017428-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017428-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N017428-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N017428-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N017428-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N017428-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N017428-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017428-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N017428-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N017428-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N017428-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N017428-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N017428-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N017428-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017428-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N017428-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N017428-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017428-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017428-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017428-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017428-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N017428-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N017428-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017428-001 | AT | 1 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | Baxter Healthcare Corporation | ef3e79c5-3f58-4b36-a296-64b7d9a651c1 | 2017-10-17 | Warnings, Adverse reactions | 0338-0004-02 0338-0004-05 0338-0004-03 0338-0004-04 0338-0004 00338000404 00338000402 00338000405 00338000403 |
| 2ba47d77-e661-48e2-a844-a2447e94daeb | fb20b834-4ca2-4ef0-ab16-8c7e1e3cd3b9 | 2014-02-21 | Warnings | 2ba47d77-e661-48e2-a844-a2447e94daeb fb20b834-4ca2-4ef0-ab16-8c7e1e3cd3b9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.