STERILE WATER FOR INJECTION

Manufacturer
Baxter Healthcare Company | Baxter Corporation
Effective date
2024-12-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:34:37

Label at a glance#

ProductSterile Water
Active ingredientWATER
Label structure2 sections

Label contents#

Full prescribing information#

Health Care Professional Letter

HEALTH CARE PROVIDER LETTER SECTION

DCHP Letter 1
DCHP Letter 1
DCHP Letter 2
DCHP Letter 2

Reporting Adverse Events or Product Quality Issues

To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1-800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).

To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (productfeedback.baxter.com)

DCHP Letter 3
DCHP Letter 3

Please refer to the FDA-approved prescribing information for each drug product listed below:

• Sterile Water for Injection USP (click www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf)
• 70% Dextrose Injection USP (click www.accessdata.fda.gov/drugsatfda_docs/label/2019/020047s021lbl.pdf)

DCHP Letter 4
DCHP Letter 4
DCHP Letter 5
DCHP Letter 5
DCHP Letter 6
DCHP Letter 6
DCHP Letter 7
DCHP Letter 7

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label 0338-9782-01 1 of 2
Container Label 0338-9782-01 1 of 2
Container Label 0338-9782-01 2 of 2
Container Label 0338-9782-01 2 of 2

Container Label

JB0304 1000 mL DIN 02014882

Sterile WATER for
Injection USP
EAU stérile pour
injection USP

Sterile WATER / EAU stérile
Not for Direct Infusion
Ne pas utilizer pour perfuser directment
H2O

PHARMACY BULK PACKAGE / CONDITIONNEMENT EN
VRAC POUR LA PHARMACIE
SINGLE PUNCTURE, MULTIPLE DISPENSING / PERFORATION
UNIQUE, DISPENSATION MULTIPLE
DISCARD UNUSED PORTION / JETER TOUTE PARTIE INUTILISÉE

APPROX mOsmol/L 0 APPROX pH 5.5

NO ANTIMICROBIAL AGENT OR OTHER SUBSTANCE HAS BEEN ADDED / AUCUN AGENT
ANTIMICROBIEN OU AUTRE SUBSTANCE NA ÉTÉ AJOUTÉ

CAUTIONS: SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR USE / MUST NOT BE
USED IN SERIES CONNECTIONS / STORE AT 15°C ET 25°C

MISES EN GARD : PRESSER ET INSPECTOR LA POCHE / CONSULTER LE MODE
D’ÉMPLOI / NE PAS UTILISER POUR LES RACCORDS EN SÉRIE / CONSERVER ENTRE
15°C ET 25°C

CONTAINS NO MORE THAN 25 µg/L OF ALUMINUM / NE CONTINENT PAS PLUS DE
25 µg/L D’ALUMINIUM

NONPYROGENIC / STERILE / APYROGENE / STÉRILE
HYPOTONIC / ADMIX ONLY / HYPTONIQUE / POUR
MÉLANGE SUELEMENT

DOSAGE: PRESCRIBING INFORMATION AVAILABLE ON
REQUEST / POSOLOGIE : RENSEIGNEMENTS
POSOLOGIQUES DISPONIBLES SUR DEMANDE

H2O Label

VIAFLEX PVC CONTAINER / CONTENANT EN PVC VIAFLEX
BAXTER AND VIAFLEX TRADEMARKS OF BAXTER INTERNATIONAL, INC.
BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER
INTERNATIONAL, INC.

Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2

No Latex Label
07-25-77-318

JB-03-04
12 – 1000 mL units
Store at 15°C to 25°C

Sterile Water for Injection USP

Lot: WWWWWWWWW EXP: 2099 99

2DBarcode
(01)20809080000528

Pharmacy Bulk

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9782-01ML - Milliliter0338-978296eafde3-c27e-4a96-9067-68ee7a98c4c412024-12-10
0338-9782-12ML - Milliliter0338-978272a272ac-107f-46b5-a870-9198644d0a4f12025-01-14

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
0338-97820338-9782-01, 0338-9782-12

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

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
f7531c41-674a-4d2b-b292-ead2dd7372b7b28369a7-ea39-474a-b7da-b6c5f46425882024-12-18Exact identifier
spl set id: b28369a7-ea39-474a-b7da-b6c5f4642588

Reported adverse events (FAERS/openFDA)#

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