EXTRANEAL

Manufacturer
Baxter Healthcare Corporation | Baxter Corporation
Effective date
2024-11-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:49:32

Label at a glance#

ProductEXTRANEAL
Active ingredientICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Health Care Provider Letter

HEALTH CARE PROVIDER LETTER SECTION

Extraneal DHCP Letter 1
Extraneal DHCP Letter 1
Extraneal DHCP Letter 2
Extraneal DHCP Letter 2
Extraneal DHCP Letter 3
Extraneal DHCP Letter 3
Extraneal DHCP Letter 4
Extraneal DHCP Letter 4
Extraneal DHCP Letter 5
Extraneal DHCP Letter 5
Extraneal DHCP Letter 6
Extraneal DHCP Letter 6

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extraneal Representative Container Label
Extraneal Representative Container Label

JB9923L 2500 mL DIN 02240806

2D barcode
(01)00085412150116

Extraneal 7.5% Icodextrin Peritoneal
Dialysis Solution

FOR INTRAPERITONEAL ADMINISTRATION
APPROX 90 mL EXCESS / EXCES APPROX DE 90 mL
NONPYROGENIC / STERILE / APYROGENE
APPROX pH 5.2

PER/PAR 1000 mL
ICODEXTRIN / ICODEXTRINE – 75 g
SODIUM CHLORIDE / CHLORURE DE SODIUM USP – 5.35 g
SODIUM LACTATE / LACTATE DE SODIUM – 4.48 g
CALCIUM CHLORIDE DIHYDRATE / DIHYRATE DE CHLORURE DE CALCIUM USP -
257 mg
MAGNESIUM CHLORIDE HEXAHYDRATE / HEXAHYDRATE DE CHLORURE DE
MAGNESIUM USP – 51 mg
IN WATER FOR INJECTIONS / DANS DE L’EAU POUR INJECTION USP
THEORETICAL OSMOLARITY 284 mOsmol/L /
OSMOLARITE THEORIQUE 284 mOsmol/L

APPROX mmol/L Na – 132 Ca – 1.75 Mg – 0.25 Cl – 96 LACTATE – 40

NOT TO BE USED FOR INTRAVENOUS INFUSION
FOR DOSAGE ADMINISTRATION AND DETAILED DIRECTIONS FOR USE SEE
PACKAGE INSERT / PRODUCT MONOGRAPH AVAILABLE UPON REQUEST /
DO NOT USE UNLESS SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED
/ DISCARD UNUSED PORTION / STORE AT 15°C TO 25°C / DO NOT FREEZE /
KEEP OUT OF REACH OF CHILDREN

Extraneal Solution d’Icodextrine à 7,5 % pour
Dialyse Péritonéale

POUR ADMINISTRATION PAR VOIE INTRAPERITONEALE

NE PAS ADMINSTRER PAR PERFUSION INTRAEINEUSE / CONSULTER LA
NOTICE D’EMBALLAGE POUR CONNAITRE LES RENSEIGNEMENTS SUR LA
POSOLOGIE L’ADMINISTRATION ET LE MODE D’EMPLOI MONOGRAPHIE DU
PRODUIT DISPONIBLE SUR DEMANDE / NE PAS EMPLOYER SI LA SOLUTION
EST TROUBLE OU SI LE SAC EST ENDOMMAGE / JETER TOUTE PORTION
INUTILISEE / GARDER ENTRE 15 °C / PROTEGER DU GEL / GARDER
HORS DE LA PORTEE DES ENFANTS

PVC CONTAINER / CONTENANT DE PVC

BAXTER AND EXTRANEAL ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
BAXTER ET EXTRANEAL SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC

BaxterLogo
Baxter Corporation
Mississauga ON L5N 0C2

Non Latex Symbol
88-70-20-372

500 500

250 250

Extraneal Representative Carton Label
Extraneal Representative Carton Label

Store at/Garder entre 15° C to/et 25° C
5-2500 mL IN/DANS 3000 mL

JB-99-23LP ICODEXTRIN 7.5% ICODEXTRINE

EXTRANEAL™ PD SOLUTION
SOLUTION POR DP

LOT: WWWWWWWWW EXP: 2099 99

2d Barcode
(01)50085412150111

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0941-07090941-0709-01, 0941-0709-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
3009b143-a24d-b37e-e063-6294a90aa00bd6b5c4a7-deee-4c97-b000-666a5a8930982025-03-10Exact identifier
spl set id: d6b5c4a7-deee-4c97-b000-666a5a893098

Reported adverse events (FAERS/openFDA)#

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