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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 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 2024
- Label revision date
- March 21, 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 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 2024
- Label revision date
- March 21, 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 used to help prepare medications). It is made entirely from sterile water and is designed to be free of any antimicrobial agents or added buffers, ensuring its purity for medical use. This solution is typically utilized in various medical procedures where irrigation is necessary, and it can also assist in preparing nutrient mixtures that are not given through intravenous methods.
The water is contained in a flexible, nontoxic plastic container that is specifically designed for medical applications, ensuring that it remains sterile and safe for use. It is important to note that Sterile Water for Irrigation 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
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
You should be aware that this medication is not intended for injection. It's important to follow this guideline to ensure your safety and the effectiveness of the treatment. Always consult with your healthcare provider if you have any questions or concerns about how to use this medication properly.
Side Effects
You should be aware that Sterile Water for Irrigation is hypotonic, meaning it can cause the breakdown of red blood cells (hemolysis) and is not recommended for use during surgical procedures. After opening the container, it’s important to use the solution promptly to reduce the risk of bacterial growth or the formation of harmful substances (pyrogens). 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. Please note that this product is not intended for injection, and there are no known adverse reactions or risks associated with 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
If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific known signs of overdose for this medication, you should be aware of general symptoms that may indicate a problem, such as unusual drowsiness, confusion, or difficulty breathing.
If you or someone else may have taken too much of the medication, contact a healthcare professional or poison control center right away for guidance. In any case of severe symptoms, such as trouble breathing or loss of consciousness, seek emergency medical help immediately. Always prioritize safety and don't hesitate to reach out for assistance.
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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.
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 share your complete list of medications and any lab tests you undergo, as this helps in managing your health effectively.
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
It's important to ensure the safety and effectiveness of the solution you are using. Before administration, make sure the solution is clear and that the container and seal are intact. Always visually inspect the irrigation solution for any particles or discoloration. If the solution appears cloudy or has any precipitate, do not use it. Additionally, check for leaks by squeezing the container firmly; if you find any leaks, discard the solution.
Remember that the port cap should remain intact to ensure tamper evidence, and if it has been removed prematurely, do not use the solution. Always practice strict aseptic technique (a method to prevent contamination) when handling the solution. Note that this product is not intended for injection and should not be used with pressurized irrigation systems.
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 contraindicated for injection.
What should I check before using Sterile Water for Irrigation?
You should inspect the solution visually for particulate matter and discoloration, and check the container for leaks, lot number, and expiry date.
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. Discard any unused portion since it contains no preservative.
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.
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.
Can I use Sterile Water for Irrigation with pressurized irrigation systems?
No, it is not for use with pressurized irrigation systems.
What is the pH of Sterile Water for Irrigation?
The pH of Sterile Water for Irrigation is 5.7, within the range of 5.0 to 7.0.
What should I do if I find a leak in the solution container?
If leaks are found, discard the container immediately.
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 — information not available from FDA sources
Active ingredients
| ||||
| Injection | 1 mL/1 mL | ||
Product details Regulatory status — information not available from FDA sources
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, composed entirely of Sterile Water for Injection, USP. It is prepared through a distillation process and does not contain antimicrobial or bacteriostatic agents, nor added buffers. The pH of the solution is 5.7, falling within the range of 5.0 to 7.0.
The product is packaged in a flexible plastic container made from a multilayered film specifically designed for parenteral drugs, which contains no plasticizers. The solution contact layer consists of a copolymer of ethylene and propylene, ensuring that the container is nontoxic and biologically inert. The container-solution unit operates as a closed system, eliminating the need for external air entry during administration. Additionally, 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, 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
Patients using Sterile Water for Irrigation may experience adverse reactions, although none are specifically known. It is important to note that the solution is hypotonic and can cause hemolysis; therefore, its use during surgical procedures is not recommended.
To ensure safety, the contents of the container should be used promptly after opening to minimize the risk of bacterial growth or pyrogen formation. Any unused portion of the irrigating solution should be discarded, as it does not contain a preservative.
Additionally, the solution should only be used if it is clear and the container and seal are intact. It is contraindicated for injection, and there are no known concerns regarding overdosage.
Drug Interactions
There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.
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 — information not available from FDA sources
Active ingredients
| ||||
| Injection | 1 mL/1 mL | ||
Product details Regulatory status — information not available from FDA sources
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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.
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 event of an overdosage, there are currently no known symptoms or adverse effects associated with excessive intake of the medication.
Given the absence of documented overdosage effects, standard management procedures should be followed. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms or reactions, even though none have been established.
In the case of suspected overdosage, supportive care should be provided as necessary. It is recommended that healthcare providers consult local poison control centers or relevant medical authorities for guidance on management strategies, as they may offer additional insights based on the specific clinical scenario.
Continued vigilance and patient assessment are essential, as individual responses may vary.
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
Reports of suspected adverse reactions have been received and can be communicated to Fresenius Kabi USA, LLC at 1-800-551-7176 or to the FDA at 1-800-FDA-1088 or through the website www.fda.gov/medwatch.
Currently, there are no known adverse reactions associated with the use of this product.
Patient Counseling
Healthcare providers should advise 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 informed that after opening the container, the contents should be used promptly to minimize the risk of bacterial growth or pyrogen formation.
It is essential to instruct patients to discard any unused portion of the irrigating solution, as it contains no preservative. Patients should only use the solution if it is clear and the container and seal are intact. Healthcare providers should emphasize the importance of visually inspecting irrigation solutions for particulate matter and discoloration prior to administration, whenever the solution and container permit.
Patients must be cautioned not to use the solution if it appears cloudy or if any precipitate is present. They should also be advised 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 provides visual tamper evidence, and patients should be instructed not to use the solution if the port cap has been prematurely removed.
Healthcare providers should stress the importance of maintaining strict aseptic technique during handling and remind patients that the solution is for single use only, necessitating the disposal of any unused portion.
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
The product is not intended for injection and should not be used with pressurized irrigation systems. Clinicians should advise patients to use the solution only if it is clear and the container and seal are intact. Prior to administration, irrigation solutions must be visually inspected for particulate matter and discoloration, and should not be used if the solution appears cloudy or if precipitate is present.
Patients should also check the solution container for leaks by squeezing it firmly; any containers found to be leaking should be discarded. The intact port cap serves as visual tamper evidence, and the product should not be used if the port cap has been prematurely removed. Strict aseptic technique must be maintained during handling to ensure safety and efficacy.
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.