FDA Label for Sodium Chloride
View Indications, Usage & Precautions
Sodium Chloride 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.
Health Care Professional Letter
Please refer to the FDA-approved prescribing information for the drug product listed below:
• 0.9% Sodium Chloride Irrigation, USP (click https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=886f889b-f3cf-4197-b307-6cfa88c89436)• Complete and submit the report Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program• Regular mail or Fax: Download form https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program 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).
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:
To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (https://productfeedback.baxter.com/).
Package/Label Principal Display Panel
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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