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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Sodium chloride 0.9% for irrigation

Health Care Provider Letter

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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/)

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label NDC 0338-0110

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

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SODIUM CHLORIDE 
sodium chloride irrigant
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0110
Route of AdministrationIRRIGATION
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-0110-044 in 1 CARTON11/13/2024
1NDC:0338-0110-013000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage11/13/2024
Labeler - Baxter Healthcare Company (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare Ltd221478644ANALYSIS(0338-0110) , LABEL(0338-0110) , MANUFACTURE(0338-0110) , PACK(0338-0110) , STERILIZE(0338-0110)

Revised: 11/2024
Document Id: 42b82754-49e1-4463-9679-99a8f443a7d4
Set id: 99a15716-bbb9-4e33-a48d-20c58b81f392
Version: 2
Effective Time: 20241113
 
Baxter Healthcare Company