Sodium Chloride 0.9% For Irrigation

Sodium Chloride 0.9% For Irrigation
SPL v2
SPL
SPL Set ID 99a15716-bbb9-4e33-a48d-20c58b81f392
Route
IRRIGATION
Published
Effective Date 2024-11-13
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (900 mg)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Active Since 2024-11-13
Description

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 product quality issues associated with this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal ( https://productfeedback.baxter.com/ )

Medication Information

Description

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 product quality issues associated with this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal ( https://productfeedback.baxter.com/ )

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 product quality issues 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

Structured Label Content

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 product quality issues associated with this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (https://productfeedback.baxter.com/)

Package/label Principal Display Panel (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:49:29.338668 · Updated: 2026-03-14T22:33:18.370731