Sterile Water Injection
FDA Label NDC 17271-802

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Becton Dickinson And Company for the product Sterile Water (NDC 17271-802). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Description

→ Clinical Pharmacology

→ Indications And Usage

→ Contraindications

→ Warnings

→ Precautions

→ Adverse Reactions

→ Overdosage

→ Irrigation

→ Nutrient Mixtures

→ How Supplied

→ Instructions For Use:

→ Package Label - Principal Display – Sterile Water For Chloride Irrigation, Usp 1000 Ml Bag Label

→ Package Label – Principal Display – Sterile Water For Irrigation, Usp 1000 Ml Case Label

→ Package Label - Principal Display – sterile Water For Chloride Irrigation, Usp 2000 Ml Bag Label

→ Package Label – Principal Display – Sterile Water For Irrigation, Usp 2000 Ml Case Label

→ Package Label - Principal Display – Sterile Water For Irrigation, Usp 3000 Ml Bag Label

→ Package Label - Principal Display - Sterile Water For Irrigation, Usp 3000 Ml Case Label

Other

Steri-img-01.jpg (Steri Img 01)

Sterile Water for Irrigation, USP

Rx only

Description

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.

Clinical Pharmacology

Sterile Water for Irrigation is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures. It is also utilized as a pharmaceutic aid, as well as in the preparation of enteral nutrient products.

Water is hypotonic and will cause hemolysis and will be readily absorbed by the tissues during surgical procedures; therefore, its use under such conditions is not recommended.

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).

Contraindications

Not for injection.

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.

Precautions

Use only if solution is clear and container and seal are intact.

Adverse Reactions

None known.

Overdosage

None known.

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.

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.

Instructions For Use:

Not for Injection. Not for use with pressurized irrigation systems.

Check solution container composition, lot number, and expiry date.

Irrigation solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use if the solution is cloudy or precipitate is present.

Check the solution container for leaks by squeezing firmly. If leaks are found, discard.

The intact port cap provides visual tamper evidence. Do not use if port cap is prematurely removed. Maintain strict aseptic technique during handling.

To Add Medication:

1.Identify WHITE Additive Port with arrow pointing toward solution container.
2.Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward solution container.
3.Hold base of WHITE Additive Port.
4.Insert needle (18 – 23 gauge) through the center of the WHITE Additive Port's resealable septum and inject additives.
5.Mix solution container contents thoroughly.
6.WHITE Additive port must be swabbed with disinfection agent before re-puncturing.
7.Check admixture visually for particulate matter.

Preparation for Administration

1.Immediately before inserting the irrigation set, break off BLUE Administration Port Cap with the arrow pointing away from the solution container.
2.Use non-vented irrigation set or close the air-inlet on a vented set. Refer to directions for use accompanying the irrigation set.
3.Hold the base of the BLUE Administration Port, twist and push spike until fully inserted.
4.The BLUE Administration Port contains a self-sealing septum that helps prevent leakage after removing the spike. The Administration Port is not intended to be spiked more than once.
5.Suspend solution container from hanger hole.
6.For Single Use Only. Discard unused portion.