What's the difference between sterile water for injection and sterile water for irrigation?
The USP definitions do not distinguish them: both products are prepared from Water for Injection with no antimicrobial agent added. The FDA-approved labels differ in their restrictions and containers.
| Product (Baxter label) | Container | Product code | Fill volume | NDC |
|---|---|---|---|---|
| Sterile Water for Irrigation | Plastic pour bottle | 2F7112 | 250 mL | 0338-0004-02 |
| Sterile Water for Irrigation | Plastic pour bottle | 2F7113 | 500 mL | 0338-0004-03 |
| Sterile Water for Irrigation | Plastic pour bottle | 2F7114 | 1000 mL | 0338-0004-04 |
| Sterile Water for Irrigation | Plastic pour bottle | 2F7115 | 1500 mL | 0338-0004-05 |
| Sterile Water for Irrigation | Flexible plastic container | 2B7114 | 1000 mL | 0338-0003-44 |
| Sterile Water for Irrigation | Flexible plastic container | 2B7116 | 2000 mL | 0338-0003-46 |
| Sterile Water for Irrigation | Flexible plastic container | 2B7117 | 3000 mL | 0338-0003-47 |
| Sterile Water for Injection, USP | VIAFLEX plastic container | 2B0304 | 1000 mL | 0338-0013-04 |
| Sterile Water for Injection, USP — Pharmacy Bulk Package | VIAFLEX plastic container | 2B0306 | 2000 mL | 0338-0013-06 |
| Sterile Water for Injection, USP — Pharmacy Bulk Package | VIAFLEX plastic container | 2B0307 | 3000 mL | 0338-0013-08 |
| Sterile Water for Injection, USP — Pharmacy Bulk Package | VIAFLEX plastic container | 2B0309 | 5000 mL | 0338-0013-29 |
USP monographs for sterile water: injection vs irrigation
USP-NF publishes a separate monograph for each product. The DEFINITION sections, read from USP's own preview of monographs M88870_05_01 and M88880_05_01, are word-for-word identical apart from the name: "Sterile Water for Injection is prepared from Water for Injection that is sterilized and suitably packaged. It contains no antimicrobial agent or other added substance." The irrigation product is itself prepared from Water for Injection. Everything below DEFINITION in both monographs sits behind USP's paywall and was not read here.
FDA label: water for injection vs irrigation
Both labels are for Baxter Healthcare Corporation.
Both labels list pH as "5.5 (5.0 to 7.0)". Osmolarity is zero on both: the injection label prints "The osmolarity is 0"; the irrigation label says "an osmolarity of zero mOsmol/L". Neither carries a preservative: the injection label says "No antimicrobial or other substance has been added"; the irrigation label says "No antimicrobial agent or other substance has been added."
The restrictions differ. The irrigation label's Highlights state "For Irrigation only. Not for injection or infusion by usual parenteral routes. (2.1, 5.1)". Section 1 gives its indication as "Sterile Water for Irrigation is indicated for use as an irrigant. (1)". Section 2.1 says the product "is not potable water and is not intended for oral administration." The injection label's direct container is headed "For Drug Diluent Use Only". Its indication reads "Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions." The Pharmacy Bulk Package has a separate "Not for Direct Infusion" heading. It states "This solution is for compounding only, not for direct infusion." Baxter defines that presentation: "A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses." Container terms are covered on our single-dose vs multi-dose vials page.
Sterile water USP: containers and fill volumes
The irrigation label carries two container types in two materials: a plastic pour bottle "fabricated from specially formulated polyolefin… a copolymer of ethylene and propylene", which "requires no vapor barrier", and a flexible plastic container "fabricated from a specially formulated polyvinyl chloride".
Fill volumes differ. 250 mL and 500 mL appear on the irrigation label. 1500 mL appears on the irrigation label, not the injection label. 5000 mL appears only on the injection Pharmacy Bulk Package. Both labels list 1000 mL. At 1000 mL, product code and NDC distinguish them, not size. Irrigation storage is printed as "Store at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product."
The irrigation label is NDA 017428 s071 / NDA 017866 s052, revised 10/2017. The injection label is NDA 018632 s051, revised September 2014. The injection label also carries FDA's notice: "This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda".
We do not link a retail listing here. Both products are sold under the same Baxter catalogue numbers printed above — several medical distributors list 2F7114 by that code — but we could not open a listing well enough to confirm what it actually ships, and a link this page cannot verify is one it should not carry.
Sources
- USP-NF — Sterile Water for Injection, monograph M88870_05_01 (publisher's preview)
- USP-NF — Sterile Water for Irrigation, monograph M88880_05_01 (publisher's preview)
- FDA — Sterile Water for Irrigation, approved prescribing information, Baxter Healthcare Corporation, revised 10/2017
- FDA — Sterile Water for Injection, USP in VIAFLEX Plastic Container, approved labeling, Baxter Healthcare Corporation, rev. September 2014
- How we verify specifications
Specifications last verified: