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#
Contacts and useful links#
Label contents#
Full prescribing information#
Health Care Professional Letter


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)

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)




PACKAGE/LABEL PRINCIPAL DISPLAY PANEL


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 | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-9782-01 | ML - Milliliter | 0338-9782 | 96eafde3-c27e-4a96-9067-68ee7a98c4c4 | 1 | 2024-12-10 |
| 0338-9782-12 | ML - Milliliter | 0338-9782 | 72a272ac-107f-46b5-a870-9198644d0a4f | 1 | 2025-01-14 |
Products#
Every source-derived product name is available through these pages.
- Sterile Water
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0338-9782 | 0338-9782-01, 0338-9782-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f7531c41-674a-4d2b-b292-ead2dd7372b7 | b28369a7-ea39-474a-b7da-b6c5f4642588 | 2024-12-18 | b28369a7-ea39-474a-b7da-b6c5f4642588 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.