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 Provider 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: 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 productqualityissues associated with this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (https://productfeedback.baxter.com/)
Package/Label Principal Display Panel
Container Label
REF 3KB7127 3000 ml
Baxter Logo
eng Sodium Chloride 0.9% for irrigation
UROMATIC container
Isotonic
Nonpyrogenic
Not for injection
Cautions
DO NOT USE FOR ELECTROSURGERY EXCEPT WITH A BIPOLER ELECTRODE
- Do not use unless solution is clear and container is undamaged
- Discard unused content of opened container
- Do not heat this container above 65°C
fre Chlorure de sodium à 0,9% pour irrigation
ger 0,9% Natriumchlorid zum Spülen
ita Sodio cloruro 0.9% per irrigazione
Formula
Natril Chloridum 9 g – Aqua ad injectabilia ad 1000 ml
mOsm/l 308
Do Not Re-Use Symbol
Consult Instructions for Use Symbol
European Conformity Symbol
Temperature Limit 25°C Symbol
Sterile Symbol
Manufacturer Symbol
Baxter Healthcare SA
8010 Zurich, Switzerland
Made in UK
TH-35-02-060
Lot Symbol
Use-by Date Symbol
2500
2000
1500
1000
500
* Please review the disclaimer below.
