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Bacteriostatic Water
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- Active ingredient
- Water 1 mL/1 mL
- Other brand names
- 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 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 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, Solution
- Routes
- Intramuscular
- Intravenous
- Subcutaneous
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2022
- Label revision date
- October 27, 2025
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Water 1 mL/1 mL
- Other brand names
- 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 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 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, Solution
- Routes
- Intramuscular
- Intravenous
- Subcutaneous
- 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 2022
- Label revision date
- October 27, 2025
- Manufacturer
- Henry Schein, Inc.
- Registration number
- NDA018802
- NDC root
- 0404-9970
- 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
Bacteriostatic Water for Injection, USP is a sterile solution specifically designed for medical use. It contains water that is free from contaminants and includes a small amount of benzyl alcohol (a bacteriostatic preservative) to help prevent bacterial growth. This preparation is supplied in a multiple-dose container, allowing healthcare providers to withdraw the solution multiple times to dilute or dissolve medications before they are injected into the body.
This product is intended solely for parenteral use, meaning it is used for injections that are given directly into the bloodstream, muscles, or under the skin. It is important to follow the manufacturer's instructions when using Bacteriostatic Water to ensure the safe and effective administration of medications.
Uses
This medication is specifically designed for healthcare professionals to use when preparing other drugs for injection. It helps in diluting or dissolving medications that will be given through intravenous (IV), intramuscular (IM), or subcutaneous (under the skin) routes. It's important to follow the manufacturer's instructions for the specific drug being prepared to ensure safe and effective administration.
Dosage and Administration
When preparing a medication for injection, the amount of liquid you need to use for diluting or dissolving the drug depends on the specific instructions provided by the manufacturer. This includes factors like the concentration of the liquid (known as the vehicle), the dose you need, and how the medication will be given (the route of administration).
Before you receive an injection, it's important that the healthcare provider checks the medication visually. They will look for any particles or discoloration in the solution and the container, ensuring that it is safe for use. This step helps to confirm that the medication is in good condition before it is administered to you.
What to Avoid
It's important to be aware of certain situations where you should avoid using products containing benzyl alcohol. If you are caring for neonates (newborns), do not use any solutions that contain benzyl alcohol, as it can be toxic to them. Additionally, parenteral preparations (medications given by injection) with benzyl alcohol should not be used for fluid replacement or during epidural or spinal anesthesia procedures.
Always consult with your healthcare provider if you have questions about the medications you or your loved ones are using, especially in sensitive populations like infants. Your safety and well-being are the top priority.
Side Effects
You may experience some side effects from this solution, including fever, local tenderness, abscess (a collection of pus), tissue damage or infection at the injection site, and issues like blood clots or inflammation in the veins near the injection area. In some cases, the solution may leak out of the vein (extravasation), which can cause additional complications.
It's important to note that this solution is not safe for use in newborns due to the presence of benzyl alcohol, which can be toxic to them. If you are preparing medications for infants, only preservative-free sterile water should be used. Additionally, using this solution without a solute can lead to serious complications like hemolysis (destruction of red blood cells). Always consult with your healthcare provider if you have concerns about these potential side effects.
Warnings and Precautions
You should be aware that Bacteriostatic Water for Injection contains benzyl alcohol, which can be harmful to newborns. Because of this risk, it is crucial to use only preservative-free Sterile Water for Injection when preparing or diluting medications for neonates.
Additionally, if Bacteriostatic Water for Injection is given directly into a vein without mixing it with another substance, it can cause hemolysis (the breakdown of red blood cells). Therefore, it is important to follow proper guidelines for its use.
If you experience any unusual symptoms or reactions, stop using the product immediately and contact your doctor. Remember, this product is not safe for use in neonates, so please take extra precautions if you are handling medications for infants.
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 that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.
In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.
Pregnancy Use
There have been no animal studies conducted to assess the effects of Bacteriostatic Water for Injection during pregnancy. Additionally, it is unclear whether this product, especially when it contains additives, could harm a developing fetus or affect your ability to conceive. Therefore, if you are pregnant, Bacteriostatic Water for Injection should only be used if it is clearly necessary and prescribed by your healthcare provider. Always discuss any concerns or questions with your doctor to ensure the safety of you and your baby.
Lactation Use
When breastfeeding, it's important to be cautious about the medications you use, especially if they contain benzyl alcohol. This substance can be toxic to newborns, so you should avoid any solutions with benzyl alcohol while nursing. If you need to prepare or dilute medications for your baby, make sure to use only preservative-free Sterile Water for Injection. This ensures that you are minimizing any potential risks to your infant's health. Always consult with your healthcare provider if you have questions about medications and breastfeeding.
Pediatric Use
When considering the use of Bacteriostatic Water for Injection in children, it's important to note that its safety and effectiveness have not been established for pediatric patients. This means that there isn't enough evidence to confirm that it is safe or works well for kids.
Additionally, if your child is a newborn (also known as a neonate), you should avoid using any solutions that contain benzyl alcohol. This is because these solutions can potentially be harmful to very young infants. Always consult with your healthcare provider for the best options for your child's 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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.
Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.
Hepatic Impairment
If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.
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 best performance and safety of your product, store it at a temperature between 20 to 25°C (68 to 77°F). This range is considered a controlled room temperature, which helps maintain the integrity of the device.
When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.
Additional Information
No further information is available.
FAQ
What is Bacteriostatic Water for Injection, USP?
Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection that contains benzyl alcohol as a preservative.
What is the purpose of Bacteriostatic Water for Injection?
It is designed solely for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection.
What precautions should be taken when using Bacteriostatic Water for Injection?
You should not use it in neonates due to the potential toxicity of benzyl alcohol, and it should not be used for fluid replacement or in epidural/spinal anesthesia.
What are the potential adverse reactions associated with Bacteriostatic Water for Injection?
Possible reactions include febrile response, local tenderness, abscess, tissue necrosis, infection at the injection site, venous thrombosis, and extravasation.
What should be done before administering Bacteriostatic Water for Injection?
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration.
Is Bacteriostatic Water for Injection safe for pediatric patients?
The safety and effectiveness of Bacteriostatic Water for Injection have not been established in pediatric patients.
Can Bacteriostatic Water for Injection be used during pregnancy?
Animal reproduction studies have not been conducted, and it should only be used in pregnant women if clearly needed.
What is the storage requirement for Bacteriostatic Water for Injection?
It should be stored at 20 to 25°C (68 to 77°F).
Packaging Info
The table below lists all NDC Code configurations of Bacteriostatic Water (water), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection, Solution | 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 Bacteriostatic 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
Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection that contains 0.9% (9 mg/mL) or 1.1% (11 mg/mL) benzyl alcohol as a bacteriostatic preservative. The pH of the solution is 5.7, with a range of 4.5 to 7.0. The chemical designation of Water for Injection, USP is H2O. The semi-rigid vial is made from a specially formulated polyolefin, which is a copolymer of ethylene and propylene.
Uses and Indications
This parenteral preparation is indicated solely for the dilution or dissolution of drugs intended for intravenous, intramuscular, or subcutaneous injection, in accordance with the manufacturer's instructions for the specific drug to be administered.
Limitations of Use: This preparation should not be used for any other purpose outside of the specified indications.
Dosage and Administration
The volume of the preparation utilized for diluting or dissolving any drug for injection is contingent upon the vehicle concentration, the prescribed dose, and the route of administration as advised by the manufacturer.
Prior to administration, parenteral drug products must be visually inspected for particulate matter and discoloration, whenever the solution and container allow for such inspection. This step is crucial to ensure the safety and efficacy of the administered medication.
Contraindications
Solutions containing benzyl alcohol are contraindicated in neonates due to the potential toxicity associated with this compound.
Additionally, parenteral preparations that include benzyl alcohol should not be utilized for fluid replacement purposes.
Furthermore, the use of parenteral preparations containing benzyl alcohol is contraindicated in epidural or spinal anesthesia procedures to avoid adverse effects.
Warnings and Precautions
Benzyl alcohol, a preservative present in Bacteriostatic Water for Injection, USP, has been linked to toxicity in neonates. Due to the lack of available data regarding the toxicity of other preservatives in this age group, it is imperative that only preservative-free Sterile Water for Injection is utilized for preparing or diluting medications intended for neonates.
Healthcare professionals should be aware that the intravenous administration of Bacteriostatic Water for Injection without an accompanying solute may lead to hemolysis.
It is crucial to emphasize that Bacteriostatic Water for Injection is contraindicated for use in neonates. This warning must be strictly adhered to in order to prevent potential adverse effects.
Side Effects
Adverse reactions associated with the use of this solution, as well as added drugs or the technique of reconstitution or administration, may include a febrile response, local tenderness, abscess formation, tissue necrosis or infection at the injection site, venous thrombosis or phlebitis extending from the injection site, and extravasation.
It is important to note that the use of this solution is contraindicated in neonates due to the potential toxicity of benzyl alcohol, a preservative present in Bacteriostatic Water for Injection, USP. The safety and effectiveness of this product have not been established in pediatric patients, and intravenous administration without a solute may lead to hemolysis.
In clinical practice, the administration of solutions containing benzyl alcohol should be avoided in neonates, and only preservative-free Sterile Water for Injection should be utilized for preparing or diluting medications intended for this age group. Additionally, parenteral preparations containing benzyl alcohol are contraindicated for fluid replacement and should not be used in epidural or spinal anesthesia procedures.
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 necessary at this time.
Packaging & NDC
The table below lists all NDC Code configurations of Bacteriostatic Water (water), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection, Solution | 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
The safety and effectiveness of Bacteriostatic Water for Injection, USP, have not been established in pediatric patients. Caution is advised when considering its use in this population. Specifically, solutions containing benzyl alcohol should not be used in neonates due to the potential for toxicity.
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
Animal reproduction studies have not been conducted with Bacteriostatic Water for Injection. Therefore, the effects of Bacteriostatic Water for Injection on fetal outcomes or reproduction capacity in humans are not known. Given the lack of data, Bacteriostatic Water for Injection, USP containing additives should be administered to pregnant patients only if clearly needed. Healthcare professionals should weigh the potential risks against the benefits when considering the use of this product in pregnant women.
Lactation
Lactating mothers should be aware that solutions containing benzyl alcohol are contraindicated in neonates due to the potential toxicity associated with this compound. Therefore, lactating mothers should avoid using any medications that contain benzyl alcohol when breastfeeding.
When preparing or diluting medications for use in neonates, it is essential to utilize only preservative-free Sterile Water for Injection. This precaution helps ensure the safety of breastfed infants.
Renal Impairment
There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.
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, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.
Nonclinical Toxicology
Animal reproduction studies have not been conducted with Bacteriostatic Water for Injection. It is not known whether Bacteriostatic Water for Injection containing additives can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, Bacteriostatic Water for Injection, USP containing additives should be given to a pregnant woman only if clearly needed.
Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. Although adverse reactions to intravenous, intramuscular, or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in humans, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose of up to 30 mL may be safely administered to an adult without toxic effects. However, administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes.
The safety of the plastic used in the containers has been confirmed by tests in animals according to USP biological standards for plastic containers.
Postmarketing Experience
Postmarketing experience has identified several important considerations regarding the use of Bacteriostatic Water for Injection, USP. Benzyl alcohol, a preservative in this formulation, has been associated with toxicity in neonates. Currently, data on the toxicity of other preservatives in this age group are not available. It is recommended that only preservative-free Sterile Water for Injection be used when preparing or diluting medications for neonates.
Intravenous administration of Bacteriostatic Water for Injection without a solute may lead to hemolysis. Additionally, reactions that may occur due to this solution, the added drugs, or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the injection site, venous thrombosis or phlebitis extending from the injection site, and extravasation.
In the event of an adverse reaction, it is advised to discontinue the infusion, evaluate the patient, and implement appropriate countermeasures. If feasible, the remainder of the unused vehicle should be retrieved and saved for examination.
While adverse reactions to intravenous, intramuscular, or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in humans, experimental studies in various animal species have suggested that an estimated intravenous dose of up to 30 mL may be safely administered to an adult without toxic effects. However, administration of approximately 9 mL to a 6 kg infant or neonate may potentially result in blood pressure changes.
Patient Counseling
Healthcare providers should advise patients that Bacteriostatic Water for Injection, USP is specifically indicated for diluting or dissolving drugs intended for intravenous, intramuscular, or subcutaneous injection, in accordance with the manufacturer's instructions for the drug being administered.
It is crucial to inform patients that solutions containing benzyl alcohol are contraindicated in neonates due to the potential toxicity associated with this substance. Additionally, parenteral preparations containing benzyl alcohol should not be utilized for fluid replacement or in procedures involving epidural or spinal anesthesia.
Healthcare providers must emphasize the importance of ensuring that Bacteriostatic Water for Injection, USP is made approximately isotonic prior to use. They should encourage patients to consult the manufacturer's instructions regarding the selection of the appropriate vehicle, as well as the correct dilution or volume necessary for dissolving the drugs intended for injection, including guidance on the route and rate of administration.
Patients should be instructed to inspect reconstituted drugs for clarity and to check for any unexpected precipitation or discoloration before administration. The use of aseptic technique is essential for both single and multiple entries and withdrawals from all containers.
When diluting or dissolving drugs, healthcare providers should advise patients to mix the solutions thoroughly and to use them promptly. It is important to inform patients not to store reconstituted solutions of drugs for injection unless specifically directed by the manufacturer of the solute. Lastly, patients should be cautioned not to use the solution unless it is clear and the seal is intact.
Storage and Handling
The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20 to 25°C (68 to 77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature. Proper storage conditions are essential to maintain the integrity and efficacy of the product.
Additional Clinical Information
No further data are available.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Bacteriostatic Water as submitted by Henry Schein, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.