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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 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 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
- October 22, 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 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 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
- October 22, 2025
- Manufacturer
- Becton Dickinson and Company
- Registration number
- ANDA216123
- NDC root
- 17271-802
- 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 solvent) in medical settings. It is made entirely from Sterile Water for Injection and is designed to be free of any antimicrobial agents or added buffers, ensuring its purity and safety for specific medical applications.
This sterile water is typically used to help cleanse or irrigate tissues during medical procedures and can also assist in preparing nutrient mixtures that are not administered intravenously. It is important to note that this product is not intended for 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
Before using this medication, make sure to follow your physician's instructions carefully. It's important to visually inspect the drug for any particles or discoloration before you use it, whenever possible. This ensures that the solution is safe for administration.
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 does not 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 for administering the nutrient mixture to the patient, as long as it is appropriate for the situation.
What to Avoid
It’s important to know that this medication should not be injected. Using it in this way can lead to serious health risks and complications. Always follow the prescribed method of administration to ensure your safety and the effectiveness of the treatment. If you have any questions about how to use this medication properly, please consult your healthcare provider.
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
It's important to be aware that Sterile Water for Irrigation is hypotonic, meaning it can cause hemolysis (the breakdown of red blood cells), and should not be used during surgical procedures. To ensure safety, use the solution promptly after opening the container to reduce the risk of bacterial growth or the formation of pyrogens (substances that can cause fever).
Make sure to discard any unused portion of the irrigating solution, as it does not contain preservatives to keep it safe for later use. If you notice any unusual reactions or symptoms after using this solution, stop use immediately and contact your doctor for further guidance.
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’s 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
If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. The insert does not indicate that the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any risks to the developing fetus. Additionally, there are no dosage changes or special precautions suggested for use while pregnant.
As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to know 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 baby 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
When it comes to using this medication in children, there is currently no specific information available regarding recommended ages, dosing differences, or safety concerns. This means that the manufacturer has not provided guidelines or precautions specifically for pediatric use (which refers to the treatment of children).
If you are considering this medication for your child, it is essential to consult with a healthcare professional who can provide personalized advice and ensure the safety and effectiveness of the treatment for your child's specific needs.
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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how safe it is for you.
If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine the best approach, taking into account any unique health needs or concerns that may arise with age. Always prioritize open communication with your doctor to ensure safe and effective treatment.
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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.
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 you receive is safe and appropriate for your liver condition. They can help monitor your health and make any necessary adjustments to your care.
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 tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.
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 that are sterile (free from germs) and nonpyrogenic (not causing fever). Always use the product as directed and dispose of any unused portions according to local regulations to maintain safety and hygiene.
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 to prepare non-intravenously administered nutrient mixtures.
Is Sterile Water for Irrigation safe for injection?
No, Sterile Water for Irrigation is not for injection and should not be used with pressurized irrigation systems.
What should I check before using Sterile Water for Irrigation?
You should inspect the solution container for particulate matter, discoloration, leaks, and ensure the container and seal are intact.
What precautions should I take when using Sterile Water for Irrigation?
Use only if the solution is clear and the container is intact. After opening, use the contents promptly to minimize bacterial growth.
What are the storage conditions for Sterile Water for Irrigation?
Store at 20° to 25°C (68° to 77°F) and protect from freezing. Brief exposure up to 40°C (104°F) does not adversely affect the product.
Are there any known adverse reactions to 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?
There is no specific information regarding its use during pregnancy, but it is not contraindicated.
What should I do with unused Sterile Water for Irrigation?
Discard any unused portion since it contains no preservative.
How should I prepare Sterile Water for Irrigation for administration?
Break off the BLUE Administration Port Cap before inserting the irrigation set and use a non-vented irrigation set or close the air-inlet on a vented set.
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 the container-solution unit operates as a closed system, not requiring the entry of external air during administration. The product 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, whenever the solution and container permit.
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.
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
Patients receiving Sterile Water for Irrigation may experience no known adverse reactions. However, it is important to note several warnings and precautions associated with 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 prior to use. Additionally, Sterile Water for Irrigation is contraindicated for injection.
There are no known concerns regarding overdosage associated with this product.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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, including recommended ages, dosing differences, safety concerns, or special precautions for children. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the absence of relevant data.
Geriatric Use
Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.
Pregnancy
Pregnant patients may use this product as there is no specific information provided regarding its use during pregnancy. The prescribing information does not indicate any contraindications for use in pregnant individuals, nor does it outline any associated risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for pregnant patients. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering this product for use in pregnant patients.
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 and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.
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 clinical trials for 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
There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.
In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.
For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.
Nonclinical Toxicology
The available nonclinical data indicate that there are no known teratogenic effects associated with the compound. Additionally, there are no identified non-teratogenic effects. The absence of adverse findings in these categories suggests a favorable safety profile in terms of developmental toxicity.
No further nonclinical toxicology data or specific animal pharmacology and toxicology information has been provided.
Postmarketing Experience
Postmarketing experience has not identified any known adverse reactions associated with the use of the product. Reports received voluntarily or through surveillance programs have not indicated any additional safety concerns.
Patient Counseling
Healthcare providers should advise patients that Sterile Water for Irrigation is intended solely for irrigation purposes and is not suitable for injection. It is important to inform patients that after opening the container, the contents should be used promptly to reduce the risk of bacterial growth or pyrogen formation.
Patients should be instructed to discard any unused portion of the irrigating solution, as it does not contain preservatives. They must also be reminded to use the solution only if it is clear and the container and seal are intact. Prior to administration, patients should visually inspect the irrigation solution for any particulate matter or discoloration, ensuring that both the solution and container permit such inspection.
Healthcare providers should emphasize that the solution must not be used if it appears cloudy or if any precipitate is present. Patients should check the solution container for leaks by squeezing it firmly; if any leaks are detected, the solution should be discarded. It is crucial to maintain strict aseptic technique during handling to prevent contamination. Finally, patients should be made aware that this solution is for single use only and any unused portion should 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). Brief exposure to temperatures up to 40°C (104°F) is acceptable and does not adversely affect the product. Additionally, it is crucial to protect the containers from freezing to maintain their quality and 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 Becton Dickinson and Company. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.