STERILE WATER- water injection, solution

Sterile Water by

Drug Labeling and Warnings

Sterile Water by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Company, Baxter Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (https://productfeedback.baxter.com)

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

Sterile Water for Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf)
70% Dextrose Injection USP (click https://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

INGREDIENTS AND APPEARANCE

STERILE WATER 
water injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9782
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	100 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9782-12	12 in 1 CARTON	10/18/2024
1	NDC: 0338-9782-01	1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/18/2024

Labeler - Baxter Healthcare Company (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Corporation		205087968	ANALYSIS(0338-9782) , LABEL(0338-9782) , MANUFACTURE(0338-9782) , STERILIZE(0338-9782) , PACK(0338-9782)