FDA Label for Sterile Water

View Indications, Usage & Precautions

Sterile Water Product Label

The following document was submitted to the FDA by the labeler of this product Baxter Healthcare Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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