Sterile Water WATER BECTON DICKINSON AND COMPANY 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 flexible plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a 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. Not made with natural rubber latex, PVC or DEHP.
FunFoxMeds bottle
Substance Water
Route
IRRIGATION
Applications
ANDA216123

Drug Facts

Composition & Profile

Strengths
1000 ml 1500 ml 2000 ml 3000 ml
Quantities
07 pack 1000 ml 1500 ml 08 pack 2000 ml 09 pack 3000 ml 000 ml
Treats Conditions
Indications And Usage Sterile Water For Irrigation 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 flexible plastic containers. Product Code Unit of Sale Each 1727180207 NDC 17271-802-07 Package of 6 bags NDC 17271-802-07 1000 mL fill in a 1500 mL bag 1727180208 NDC 17271-802-08 Package of 5 bags NDC 17271-802-08 2000 mL fill in a 2000 mL bag 1727180209 NDC 17271-802-09 Package of 4 bags NDC 17271-802-09 3000 mL fill in a 3000 mL bag Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]; however, brief exposure up to 40°C (104°F) does not adversely affect the product.; PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Chloride Irrigation, USP 1000 mL Bag Label solu flex ® NDC 17271- 802 -07 1000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION steri-label-03.jpg; PACKAGE LABEL – PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 1000 mL Case Label NDC 17271-802-07 1727180207 Sterile Water for Irrigation, USP 1,000 mL x 6 STORE AT : 20 ° to 25 ° C ( 68 ° to 77 ° F ) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. steri-label-04.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Chloride Irrigation, USP 2000 mL Bag Label solu flex ® NDC 17271- 802 -08 2000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION steri-label-05.jpg; PACKAGE LABEL – PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 2000 mL Case Label NDC 17271-802-08 1727180208 Sterile Water for Irrigation, USP 2,000 mL x 5 STORE AT : 20 ° to 25 ° C ( 68 ° to 77 ° F ) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. steri-label-06.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 3000 mL Bag Label solu flex ® NDC 17271- 802 -09 3000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION steri-label-01.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water for Irrigation, USP 3000 mL Case Label NDC 17271-802-09 1727180209 Sterile Water for Irrigation, USP 3,000 mL x 4 STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. steri-label-02.jpg

Package Descriptions
  • HOW SUPPLIED Sterile Water for Irrigation, USP is supplied sterile and nonpyrogenic in single dose flexible plastic containers. Product Code Unit of Sale Each 1727180207 NDC 17271-802-07 Package of 6 bags NDC 17271-802-07 1000 mL fill in a 1500 mL bag 1727180208 NDC 17271-802-08 Package of 5 bags NDC 17271-802-08 2000 mL fill in a 2000 mL bag 1727180209 NDC 17271-802-09 Package of 4 bags NDC 17271-802-09 3000 mL fill in a 3000 mL bag Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]; however, brief exposure up to 40°C (104°F) does not adversely affect the product.
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Chloride Irrigation, USP 1000 mL Bag Label solu flex ® NDC 17271- 802 -07 1000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION steri-label-03.jpg
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 1000 mL Case Label NDC 17271-802-07 1727180207 Sterile Water for Irrigation, USP 1,000 mL x 6 STORE AT : 20 ° to 25 ° C ( 68 ° to 77 ° F ) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. steri-label-04.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Chloride Irrigation, USP 2000 mL Bag Label solu flex ® NDC 17271- 802 -08 2000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION steri-label-05.jpg
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 2000 mL Case Label NDC 17271-802-08 1727180208 Sterile Water for Irrigation, USP 2,000 mL x 5 STORE AT : 20 ° to 25 ° C ( 68 ° to 77 ° F ) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. steri-label-06.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 3000 mL Bag Label solu flex ® NDC 17271- 802 -09 3000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION steri-label-01.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water for Irrigation, USP 3000 mL Case Label NDC 17271-802-09 1727180209 Sterile Water for Irrigation, USP 3,000 mL x 4 STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. steri-label-02.jpg

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 flexible plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a 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. Not made with natural rubber latex, PVC or DEHP.

Indications & Usage

Sterile Water for Irrigation 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 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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