STERILE WATER

Manufacturer
Baxter Healthcare Corporation
Effective date
2014-02-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:36:03

Label at a glance#

ProductSTERILE WATER
Active ingredientWATER
Label structure6 sections

Indications and uses

For irrigation only. Not for injection.

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.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For irrigation only. Not for injection.

WARNINGS

WARNINGS SECTION

This solution is not isotonic and is hemolytic.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

HOW SUPPLIED

HOW SUPPLIED SECTION

Recommended storage: Room temperature (25°C). Avoid excessive heat.

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label
Container Label

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

Carton Label (07-06-47-986)
Carton Label (07-06-47-986)

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0004-02ML - Milliliter0338-000497a1a26a-8bbb-4cad-8455-fae5ff1747e312012-07-24
0338-0004-03ML - Milliliter0338-0004b8f88bb5-7ea5-4093-8e7b-89e5f3af2f7b12013-02-13
0338-0004-04ML - Milliliter0338-000424fbca35-41e2-431e-97e2-19f0ca2b522c12012-07-24
0338-0004-05ML - Milliliter0338-00041ed29dd4-04b1-43e5-874f-62b19ba6b64212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0R2
WATERACTIVE MOIETY059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-00040338-0004-02, 0338-0004-03, 0338-0004-04, 0338-0004-05

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RACTIB

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 44.

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
N017428-001STERILE WATERSTERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONATRLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N017428-001AT

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982c2088c7a36db…
2026-09-14 22:38:342026-08N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017428-001STERILE WATER100%LIQUID / IRRIGATIONATApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017428-001STERILE WATER100%LIQUID / IRRIGATIONATApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017428-001STERILE WATER100%LIQUID / IRRIGATIONATRLD, Approved before 19823a93d1ddd44b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N017428-001AT1c2088c7a36db…
2026-09-14 22:38:342026-08N017428-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N017428-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017428-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017428-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017428-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017428-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017428-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017428-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017428-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017428-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017428-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017428-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017428-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017428-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017428-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017428-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017428-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017428-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017428-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017428-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017428-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017428-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017428-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N017428-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017428-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017428-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017428-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N017428-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017428-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017428-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017428-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017428-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017428-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017428-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017428-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017428-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017428-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017428-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017428-001AT13a93d1ddd44b…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
ndc (package): 0338-0004-02
ndc (package): 0338-0004-05
ndc (package): 0338-0004-03
ndc (package): 0338-0004-04
ndc (product): 0338-0004
ndc11 (package): 00338000404
ndc11 (package): 00338000402
ndc11 (package): 00338000405
ndc11 (package): 00338000403
2ba47d77-e661-48e2-a844-a2447e94daebfb20b834-4ca2-4ef0-ab16-8c7e1e3cd3b92014-02-21WarningsExact identifier
spl id: 2ba47d77-e661-48e2-a844-a2447e94daeb
spl set id: fb20b834-4ca2-4ef0-ab16-8c7e1e3cd3b9

Reported adverse events (FAERS/openFDA)#

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