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Sterile Water
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- Active ingredient
- Water 1 mL/1 mL
- Other brand names
- Bacteriostatic Water (by Henry Schein, Inc.)
- Bacteriostatic Water (by Hospira, Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Corporation)
- Sterile Water (by Becton Dickinson and Company)
- Sterile Water (by Becton Dickinson and Company)
- Sterile Water (by Cardinal Health 107, Llc)
- Sterile Water (by Cardinal Health 107, Llc)
- Sterile Water (by Chartwell Rx, Llc)
- Sterile Water (by Civica, Inc.)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by General Injectables and Vaccines, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Hikma Pharmaceuticals Usa Inc.)
- Sterile Water (by Hikma Pharmaceuticals Usa Inc.)
- Sterile Water (by Hospira, Inc.)
- Sterile Water (by Hospira, Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Medefil, Inc.)
- Sterile Water (by Nephron Pharmaceuticals Corporation)
- View full label-group details →
- Dosage form
- Injection
- Route
- Irrigation
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2025
- Label revision date
- November 18, 2025
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Water 1 mL/1 mL
- Other brand names
- Bacteriostatic Water (by Henry Schein, Inc.)
- Bacteriostatic Water (by Hospira, Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Corporation)
- Sterile Water (by Becton Dickinson and Company)
- Sterile Water (by Becton Dickinson and Company)
- Sterile Water (by Cardinal Health 107, Llc)
- Sterile Water (by Cardinal Health 107, Llc)
- Sterile Water (by Chartwell Rx, Llc)
- Sterile Water (by Civica, Inc.)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by General Injectables and Vaccines, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Hikma Pharmaceuticals Usa Inc.)
- Sterile Water (by Hikma Pharmaceuticals Usa Inc.)
- Sterile Water (by Hospira, Inc.)
- Sterile Water (by Hospira, Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Medefil, Inc.)
- Sterile Water (by Nephron Pharmaceuticals Corporation)
- View full label-group details →
- Dosage form
- Injection
- Route
- Irrigation
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2025
- Label revision date
- November 18, 2025
- Manufacturer
- Fresenius Kabi USA, LLC
- Registration number
- ANDA216123
- NDC roots
- 65219-495, 65219-497, 65219-499
- FDA Insert
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
Sterile Water for Irrigation, USP is a specially prepared sterile fluid that is used primarily as an irrigating solution or as a pharmaceutic aid (a substance that helps in the preparation of medications). It is made entirely from sterile water and is designed to be nonpyrogenic (not causing fever) and hypotonic (having a lower concentration of solutes than the fluid inside cells). This solution is packaged in a flexible, nontoxic container that is safe for medical use and does not contain harmful substances like natural rubber latex or PVC.
You may find Sterile Water for Irrigation useful in various medical procedures, particularly for irrigation purposes or as a component in preparing nutrient mixtures that are not given through an intravenous route. However, it is important to note that this product is not intended for direct injection.
Uses
Sterile Water for Irrigation is primarily used as an irrigating fluid or as a pharmaceutic aid in various medical procedures. This means it helps to clean or wash out areas during surgeries or other treatments. Additionally, it can be used to assist in preparing nutrient mixtures that are not given through an intravenous (IV) line, making it a versatile option in medical settings.
It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with Sterile Water for Irrigation. This makes it a safe choice for its intended uses.
Dosage and Administration
It's important to follow your physician's instructions when using this medication. Before you take or apply it, make sure to visually inspect the solution for any particles or discoloration, as this can indicate that the product is not safe to use.
If you need to prepare a nutrient mixture that is not given through a vein (non-intravenous), you can use Sterile Water for Irrigation, which is a special type of water that doesn't contain any added substances or electrolytes. Be sure to check the specific preparation instructions for the mixture you are using. You can also use the plastic container provided for administering the nutrient mixture, as long as it is appropriate for your needs.
What to Avoid
It's important to know that this medication is not intended for injection. Using it in this way can lead to serious health risks.
Additionally, while there are no specific "do not take/use" instructions provided, always consult with your healthcare provider if you have any concerns or questions about how to use this medication safely. Remember, responsible use is key to avoiding potential issues like misuse or dependence (a condition where your body becomes reliant on a substance).
Side Effects
You should be aware that there are no known adverse reactions associated with Sterile Water for Irrigation. However, it is important to note that this solution is hypotonic, meaning it can cause hemolysis (the breakdown of red blood cells), and it is not recommended for use during surgical procedures. After opening the container, use the solution promptly to reduce the risk of bacterial growth or the formation of harmful substances. Any unused portion should be discarded, as the solution does not contain preservatives.
Additionally, ensure that the solution is clear and that the container and seal are intact before use. Remember, this product is not intended for injection. There are no known issues related to overdosage.
Warnings and Precautions
Using Sterile Water for Irrigation comes with important safety considerations. This solution is hypotonic, meaning it can cause hemolysis (the breakdown of red blood cells), so it is not recommended for use during surgical procedures. To ensure safety, you should use the solution promptly after opening the container to reduce the risk of bacterial growth or the formation of harmful substances.
It's crucial to discard any unused portion of the solution, as it does not contain preservatives that would prevent contamination. If you notice any unusual reactions or symptoms after using this solution, stop use immediately and contact your doctor for further guidance. Always prioritize your health and safety when using medical products.
Overdose
It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.
In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.
Pregnancy Use
There is currently no specific information available about the use of this medication during pregnancy. This means that the insert does not provide any warnings or guidelines regarding safety concerns, dosage changes, or special precautions for pregnant individuals.
If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before taking any medication to ensure it is safe for you and your baby.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.
As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.
Pediatric Use
Currently, there is no specific information available regarding the use of this medication in children. This means that there are no recommended ages, dosage differences, or safety concerns outlined for pediatric patients (children). If you are considering this medication for a child, it is important to consult with a healthcare professional to ensure it is appropriate and safe for their specific needs. Always prioritize your child's health and well-being by seeking expert advice.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.
If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.
Renal Impairment
If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.
Hepatic Impairment
If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.
Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.
Storage and Handling
To ensure the safety and effectiveness of your Sterile Water for Irrigation, it's important to store it properly. Keep the product in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Avoid exposing it to excessive heat or freezing temperatures, as these conditions can compromise its quality. While brief exposure to temperatures up to 40°C (104°F) is acceptable, it's best to minimize heat exposure whenever possible.
When handling the Sterile Water for Irrigation, remember that it comes in single-dose flexible plastic containers, which are designed to be sterile (free from germs) and nonpyrogenic (not causing fever). Always use the product as directed and dispose of any unused portions safely to maintain hygiene and safety standards.
Additional Information
No further information is available.
FAQ
What is Sterile Water for Irrigation, USP?
Sterile Water for Irrigation, USP is a sterile, hypotonic, nonpyrogenic irrigating fluid composed entirely of Sterile Water for Injection, USP, prepared by distillation.
What are the indications for using Sterile Water for Irrigation?
It is indicated for use as an irrigating fluid or pharmaceutic aid and may also be used as an adjunct in preparing non-intravenously administered nutrient mixtures.
Is Sterile Water for Irrigation safe for injection?
No, Sterile Water for Irrigation is contraindicated for injection.
What should I check before using Sterile Water for Irrigation?
You should inspect the solution visually for particulate matter and discoloration, check the container for leaks, and ensure the solution is clear and the seal is intact.
What precautions should I take when using Sterile Water for Irrigation?
Use only if the solution is clear and the container and seal are intact. After opening, use the contents promptly to minimize bacterial growth.
What should I do if the solution is cloudy or has precipitate?
Do not use the solution if it is cloudy or if precipitate is present.
How should I store Sterile Water for Irrigation?
Store it at 20° to 25°C (68° to 77°F) and protect it from freezing and excessive heat.
What are the adverse reactions associated with Sterile Water for Irrigation?
There are no known adverse reactions associated with Sterile Water for Irrigation.
Can Sterile Water for Irrigation be used during pregnancy?
No specific information regarding its use during pregnancy is provided, but there are no contraindications mentioned.
What should I do with unused portions of Sterile Water for Irrigation?
Discard any unused portion since it contains no preservative.
Packaging Info
The table below lists all NDC Code configurations of Sterile Water (water), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection | 1 mL/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Injection | 1 mL/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Injection | 1 mL/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Sterile Water, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Sterile Water for Irrigation, USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) composed entirely of Sterile Water for Injection, USP. The pH of the solution is 5.7, with a range of 5.0 to 7.0. It is packaged in a flexible plastic container made from a multilayered film specifically developed for parenteral drugs, which contains no plasticizers. The solution contact layer consists of a copolymer of ethylene and propylene. The container is nontoxic and biologically inert, and it is not made with natural rubber latex, PVC, or DEHP.
Uses and Indications
Sterile Water for Irrigation is indicated for use as an irrigating fluid or pharmaceutic aid in various medical procedures. Additionally, Sterile Water may be utilized as an adjunct in the preparation of non-intravenously administered nutrient mixtures.
There are no teratogenic or nonteratogenic effects associated with the use of Sterile Water for Irrigation.
Dosage and Administration
Healthcare professionals should administer this drug product as directed by the physician. Prior to administration, the solution must be visually inspected for particulate matter and discoloration, ensuring that both the solution and container permit such inspection.
For the preparation of non-intravenously administered nutrient mixtures, Sterile Water for Irrigation, USP may be utilized. This preparation contains no electrolytes or other added substances. It is essential to refer to the specific preparation instructions for the nutrient mixture being used.
The plastic container provided may be employed for the administration of the non-intravenous nutrient mixture to the patient, as deemed appropriate by the healthcare provider.
Contraindications
Use of this product is contraindicated for injection.
Warnings and Precautions
Sterile Water for Irrigation is classified as hypotonic, which poses a risk of hemolysis. Therefore, its use during surgical procedures is not recommended due to the potential for adverse effects on patient safety.
To ensure the integrity and safety of the solution, it is imperative that the contents of the container be utilized promptly after opening. This practice minimizes the risk of bacterial growth and the formation of pyrogens, which could compromise patient outcomes.
Healthcare professionals should also be aware that any unused portion of the irrigating solution must be discarded, as it does not contain preservatives. This precaution is essential to prevent the risk of contamination and to maintain the highest standards of patient care.
Side Effects
There are no known adverse reactions associated with the use of Sterile Water for Irrigation. However, it is important to note several warnings and precautions related to its use.
Sterile Water for Irrigation is hypotonic and may cause hemolysis; therefore, it is not recommended for use during surgical procedures. To minimize the risk of bacterial growth or pyrogen formation, the contents of the container should be used promptly after opening. Any unused portion of the irrigating solution should be discarded, as it contains no preservative.
It is crucial to ensure that the solution is clear and that both the container and seal are intact before use. Additionally, Sterile Water for Irrigation is contraindicated for injection. There are no known issues related to overdosage.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.
Packaging & NDC
The table below lists all NDC Code configurations of Sterile Water (water), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection | 1 mL/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Injection | 1 mL/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Injection | 1 mL/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
Pediatric Use
There is no specific pediatric use information available for this medication. The prescribing information does not include recommended ages, dosing differences, safety concerns, or special precautions for pediatric patients, including children and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the absence of relevant data.
Geriatric Use
There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.
Pregnancy
There is no specific information regarding the use of this medication during pregnancy. The prescribing information does not indicate any contraindications, safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to monitor pregnant patients closely if this medication is deemed necessary.
Lactation
There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.
Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.
Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.
In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.
Nonclinical Toxicology
Teratogenic effects have not been observed in nonclinical studies. Additionally, there are no known non-teratogenic effects associated with the compound.
No specific data regarding nonclinical toxicology or animal pharmacology and toxicology have been provided.
Postmarketing Experience
No postmarketing adverse events have been reported. To report suspected adverse reactions, healthcare professionals and patients are encouraged to contact Fresenius Kabi USA, LLC at 1-800-551-7176 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Patient Counseling
Healthcare providers should advise patients that the product is not intended for injection. It is important to inform patients that Sterile Water for Irrigation is hypotonic and may cause hemolysis; therefore, it is not recommended for use during surgical procedures.
Patients should be instructed to use the contents of the container promptly after opening to minimize the risk of bacterial growth or pyrogen formation. They should be made aware that any unused portion of the irrigating solution must be discarded, as it contains no preservative.
Healthcare providers should emphasize the importance of using the solution only if it is clear and the container and seal are intact. Patients should be encouraged to visually inspect the drug product for any particulate matter or discoloration prior to administration, whenever the solution and container permit. They should not use the solution if it appears cloudy or if any precipitate is present.
Patients should also be instructed to check the solution container for leaks by squeezing it firmly; if any leaks are detected, the solution should be discarded. The intact port cap serves as visual tamper evidence, and patients should be advised not to use the product if the port cap has been prematurely removed.
Finally, healthcare providers should stress the importance of maintaining strict aseptic technique during handling and remind patients that the product is for single use only, with any unused portion needing to be discarded.
Storage and Handling
Sterile Water for Irrigation, USP is supplied in single-dose flexible plastic containers that are sterile and nonpyrogenic. To ensure the integrity of the product, it is essential to minimize exposure to heat and avoid excessive temperatures. The recommended storage conditions are between 20° to 25°C (68° to 77°F). While brief exposure to temperatures up to 40°C (104°F) does not adversely affect the product, it is crucial to protect the containers from freezing to maintain their efficacy.
Additional Clinical Information
No further data are available.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Sterile Water as submitted by Fresenius Kabi USA, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.