Sodium Chloride Irrigant
FDA Label NDC 0338-9834

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Company for the product Sodium Chloride (NDC 0338-9834). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding health care professional letter, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Health Care Professional Letter

Dhcp Letter 1 Of 7 (Image 01)

Dhcp Letter 1 Of 7 (Image 01)

Dhcp Letter 2 Of 7 (Image 02)

Dhcp Letter 2 Of 7 (Image 02)

Dhcp Letter 3 Of 7 (Image 03)

Dhcp Letter 3 Of 7 (Image 03)

Dhcp Letter 4 Of 7 (Image 04)

Dhcp Letter 4 Of 7 (Image 04)

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

Package/Label Principal Display Panel

Container Label Ndc 0338-9834 (Image 08)

Container Label Ndc 0338-9834 (Image 08)

JB7127
3000 mL
DIN 00786160

0.9% Sodium Chloride
Irrigation USP

Chlorure de Sodium
à 0.9% pour Irrigation
USP

2D Barcode
(01)00809080000395

NaCl 0.9%
Irrigation

NOT FOR INJECTION / IRRIGATION ONLY
NE PAS INJECTER / POUR L’IRRIGATION
APPROX mOsmol /L – 308
APPROX pH 5.5

PER 100 mL – SODIUM CHLORIDE USP – 900 mg

PER 100 mL – CHLORURE DE SODIUM USP - 900 mg

CAUTIONS SINGLE USE / DISCARD UNUSED PORTION /
SQUEEZE AND INSPECT BAG / DO NOT USE IF THE OUTLET
PORT PROTECTOR IS DAMAGED DETACHED OR NOT PRESENT
AS SOLUTION PATH STERILITY MAY BE IMPAIRED / STORE AT
15°C TO 25°C

ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE /
PRESSER ET INSPECTER LE SAC / NE PAS UTILISER SI
L’EMBOUT DE PROTECTION DE L’ORIFICE DE SORTIE EST
ENDOMMAGÉ DÉTACHÉ OU ABSENT CAR LA STÉRILITÉ DE
LA CANALISATION POURRAIT ÊTRE COMPROMISE / GARDER
ENTRE 15°C TO 25°C

NONPYROGENIC / STERILE / APYROGENE

NaCl 0.9%

UROMATIC PVC CONTAINER/CONTENANT DE PVC

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

Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2

No Latex Label
07-25-77-352

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