SODIUM CHLORIDE- sodium chloride irrigant
Baxter Healthcare Company
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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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/)
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
| SODIUM CHLORIDE
sodium chloride irrigant |
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| Labeler - Baxter Healthcare Company (005083209) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Baxter Healthcare Ltd | 221478644 | ANALYSIS(0338-0110) , LABEL(0338-0110) , MANUFACTURE(0338-0110) , PACK(0338-0110) , STERILIZE(0338-0110) | |