boxed warning
Pharmacy Bulk Package — Not for Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.
Sterile Water
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Sterile Water
- Generic name
- WATER
- Manufacturer
- ICU Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 1c0bbcb7-5ed6-4ee7-b297-080d3359474e
- SPL ID
- 62e6c83e-4187-4dd0-9fb7-4788c3a4b432
- Version
- 6
- Effective date
- 2025-10-29
- Source export date
- 2026-10-12
- Source partition
- 14
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/acb9b4700b9af1bdda1c389c7b35bfe38fd6d1a62aa48d17832812be4029b84f/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:12:24
| Harmonized routes |
|---|
| INTRAVENOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 019869 | derived:openfda.application_number |
| application number | NDA019869 | openfda.application_number | |
| brand name | Sterile Water | openfda.brand_name | |
| generic name | WATER | openfda.generic_name | |
| manufacturer name | ICU Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0990-7118-07 | openfda.package_ndc |
| ndc | product | 0990-7118 | openfda.product_ndc |
| ndc11 | package | 00990711807 | derived:openfda.package_ndc |
| spl id | 62e6c83e-4187-4dd0-9fb7-4788c3a4b432 | id | |
| spl set id | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | set_id | |
| unii | 059QF0KO0R | openfda.unii |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS FOR DILUTION ONLY. Do not heat over 66°C (150°F). This preparation is solute-free and its entry into the circulation undiluted will cause hemolysis . Absorption of large amounts of Sterile Water for Injection, USP with additives can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.