Sterile Water STERILE WATER B. BRAUN MEDICAL INC. FDA Approved Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0-7.0) The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Not made with natural rubber latex, PVC or DEHP.
FunFoxMeds bottle
Substance Water
Route
IRRIGATION
Applications
NDA016734

Drug Facts

Composition & Profile

Strengths
3000 ml 2000 ml
Quantities
3000 ml 2000 ml 2862 set
Treats Conditions
Indications And Usage Sterile Water For Irrigation Usp Is Indicated For Use As An Irrigating Fluid Or Pharmaceutic Aid Sterile Water May Also Be Used As An Adjunct In The Preparation Of Non Intravenously Administered Nutrient Mixtures See Dosage And Administration

Identifiers & Packaging

Container Type BOTTLE
UNII
059QF0KO0R
Packaging

HOW SUPPLIED Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 and 3000 mL flexible irrigation containers packaged 4 per case. NDC REF SIZE 0264-7386-50 R8005 2000 mL 0264-7386-60 R8006 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.; PRINCIPAL DISPLAY PANEL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8005 NDC 0264-7386-50 LOT EXP. 2000 mL No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) WARNINGS: HYPOTONIC AND HEMOLYTIC See Package Insert. Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single unit container. Discard unused portion. Dosage: Irrigation. Use as directed by physician. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-063 LD-255-6 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 S ET Sterile Water Irrigation 2L Container Label Recycle 7 Symbol set arrow illustration Sterile Water Irrigation 2L Container Label; PRINCIPAL DISPLAY PANEL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8006 NDC 0264-7386-60 LOT EXP. 3000 mL No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) WARNINGS: HYPOTONIC AND HEMOLYTIC See Package Insert. Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single unit container. Discard unused portion. Dosage: Irrigation. Use as directed by physician. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-064 LD-256-6 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Sterile Water Irrigation 3L Container Label Recycle 7 Symbol set arrow illustration Sterile Water Irrigation 3L Container Label

Package Descriptions
  • HOW SUPPLIED Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 and 3000 mL flexible irrigation containers packaged 4 per case. NDC REF SIZE 0264-7386-50 R8005 2000 mL 0264-7386-60 R8006 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
  • PRINCIPAL DISPLAY PANEL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8005 NDC 0264-7386-50 LOT EXP. 2000 mL No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) WARNINGS: HYPOTONIC AND HEMOLYTIC See Package Insert. Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single unit container. Discard unused portion. Dosage: Irrigation. Use as directed by physician. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-063 LD-255-6 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 S ET Sterile Water Irrigation 2L Container Label Recycle 7 Symbol set arrow illustration Sterile Water Irrigation 2L Container Label
  • PRINCIPAL DISPLAY PANEL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8006 NDC 0264-7386-60 LOT EXP. 3000 mL No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) WARNINGS: HYPOTONIC AND HEMOLYTIC See Package Insert. Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single unit container. Discard unused portion. Dosage: Irrigation. Use as directed by physician. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-064 LD-256-6 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Sterile Water Irrigation 3L Container Label Recycle 7 Symbol set arrow illustration Sterile Water Irrigation 3L Container Label

Overview

Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0-7.0) The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Not made with natural rubber latex, PVC or DEHP.

Indications & Usage

Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION ).

Dosage & Administration

Irrigation Use as directed by physician. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nutrient Mixtures Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures. It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.

Warnings & Precautions
WARNINGS Sterile Water for Irrigation USP is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures. After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.
Contraindications

Not for injection.

Adverse Reactions

None known.


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