Water

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Active ingredient: Water 1 mL/1 mL – 1000 mL/1000 mL
Reference brand: Sterile Water
Dosage forms: Injection
Injection, Solution
Irrigant
Routes: Intramuscular
Intravenous
Irrigation
Subcutaneous
Prescription status: Rx (prescription)
Marketed in the U.S.: Since 1970
Label revision date: March 18, 2026
Pregnancy: See Pregnancy Use Section
Lactation: See Lactation Use Section

Active ingredient: Water 1 mL/1 mL – 1000 mL/1000 mL
Reference brand: Sterile Water
Dosage forms: Injection
Injection, Solution
Irrigant
Routes: Intramuscular
Intravenous
Irrigation
Subcutaneous
Prescription status: Rx (prescription)
CSA schedule: Not a scheduled drug
Marketed in the U.S.: Since 1970
Label revision date: March 18, 2026
Pregnancy: See Pregnancy Use Section
Lactation: See Lactation Use Section

Product Labels (49)

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Drug Overview

Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water specifically designed for parenteral (injection) use. It contains no bacteriostat, antimicrobial agents, or added buffers, making it suitable for diluting or dissolving drugs that require an aqueous vehicle prior to injection. This preparation is chemically designated as H₂O and is supplied in single-dose containers to ensure sterility. The pH of Sterile Water for Injection typically ranges from 5.0 to 7.0.

This product is primarily used in the preparation of intravenous, intramuscular, or subcutaneous injections, where it acts as a solvent or diluent. It is important to note that Sterile Water for Injection is not isotonic, meaning it must be mixed with an appropriate solute to achieve isotonicity before administration to avoid potential complications.

Uses

Sterile Water for Injection is primarily used as a diluent or solvent for preparing parenteral (administered by injection) solutions. This means it helps dissolve or dilute medications for intravenous (IV), intramuscular (IM), or subcutaneous (under the skin) injections, following the specific instructions provided by the drug manufacturer. It is also indicated for use with automated compounding devices to prepare intravenous admixtures in pharmacies.

In addition to its role as a diluent, Sterile Water can serve as a source of water for replenishing fluids when suitable additives are mixed in. It is important to note that this preparation is not associated with teratogenic effects (which can cause birth defects) or nonteratogenic effects, making it a safe option for use in both adults and pediatric patients.

Dosage and Administration

To use Sterile Water for Injection, you should follow the instructions provided by your healthcare provider, as the dosage depends on factors like your age, weight, and medical condition. This solution is specifically for preparing intravenous (IV) admixtures and should not be injected directly. Always ensure that the solution is clear and free from any particles or discoloration before use.

When preparing the solution, use aseptic technique (a method to prevent contamination) and mix thoroughly. After opening the container, you should use the contents promptly, ideally within 4 hours, and do not store any unused portions. If you need to add medication, puncture the additive port with a sterile needle, inject the medication, and mix well. Remember to follow all safety protocols during this process, including using a laminar flow hood for preparation.

What to Avoid

You should avoid using Sterile Water for Injection without proper additives, as it is a hemolytic agent (can cause the destruction of red blood cells) when administered intravenously in its hypotonic form. Always ensure that it is made approximately isotonic (similar in concentration to body fluids) before use. Additionally, do not administer it without the addition of a solute, and avoid using it for direct infusion or in series connections with plastic containers.

If you are using Bacteriostatic Water, be aware that it contains benzyl alcohol, which can be toxic to neonates (newborns), and should not be used for fluid replacement or in epidural/spinal anesthesia procedures.

Side Effects

You may experience several adverse reactions when using Sterile Water for Injection, including fever, local tenderness, abscess formation, tissue necrosis, and infection at the injection site. Other potential issues include venous thrombosis (blood clots in veins) and phlebitis (inflammation of veins), as well as extravasation (leakage of fluid into surrounding tissue).

It's important to note that administering Sterile Water without a solute can lead to hemolysis, which is the breakdown of red blood cells, potentially causing serious complications like renal failure. Additionally, prolonged use may result in aluminum toxicity, especially in patients with impaired kidney function or in premature neonates. Overhydration and electrolyte imbalances can also occur, particularly in very small infants. Always ensure the solution is clear and the container is undamaged before use.

Warnings and Precautions

Sterile Water for Injection is intended for dilution only and should not be used for direct infusion without adding a suitable solute. Using it undiluted can lead to hemolysis, which is the destruction of red blood cells, and may cause serious complications like renal failure.
This product contains aluminum, which can be toxic, especially for premature neonates and individuals with impaired kidney function. Prolonged use can lead to harmful levels of aluminum accumulation, affecting the central nervous system and bones. If you have kidney issues or are a premature neonate, be particularly cautious.
When using Sterile Water for Irrigation, be aware that it is hypotonic and can cause hemolysis. It is not recommended for surgical procedures. Always use it promptly after opening to prevent bacterial growth, and discard any unused portion since it contains no preservatives. If you experience any unusual symptoms or complications, contact your doctor immediately.

Overdose

If you use sterile water for injection or as a diluent, it's important to know that while it is generally safe, there can be risks associated with overhydration or fluid overload, especially in very small infants or neonates. Signs of overhydration may include confusion, disorientation, weakness, muscle twitching, headaches, nausea, vomiting, and weight gain. If you notice any of these symptoms, it’s crucial to seek medical help immediately.

In the event of suspected overhydration, healthcare providers will typically re-evaluate the patient and may need to withhold fluids until excess water is excreted. In severe cases, they might administer hypertonic saline to help balance the body's fluids. Always use sterile water as directed and consult a healthcare professional if you have any concerns.

Pregnancy Use

Animal reproduction studies have not been conducted with Sterile Water for Injection, and it is unclear whether it can cause fetal harm or affect reproductive capacity when administered to pregnant women. Sterile Water for Injection with additives should only be used during pregnancy if clearly needed. This product is classified as Pregnancy Category C, indicating that risks cannot be ruled out.

While there are no specific contraindications or safety concerns mentioned for the use of Sterile Water during pregnancy, it is essential to consult your healthcare provider before use, especially if the product contains additives. Always refer to the package insert of any solute used with Sterile Water for additional guidance.

Lactation Use

You should be aware that there is a potential for certain medications, including Sterile Water for Injection, to be excreted in breast milk, which means they can pass into your breast milk. While specific data on the effects of this medication on breastfed infants is limited, caution is advised when using it during lactation. It is important to consult with your healthcare provider to discuss any potential risks and to determine if the benefits of breastfeeding outweigh any concerns related to the use of this medication.

Additionally, if you are using Sterile Water for Injection with additives, be particularly cautious, as it is not known whether these additives can affect your infant or your milk production. Always prioritize your health and your baby's well-being by seeking professional guidance.

Pediatric Use

The safety and effectiveness of Sterile Water have been established for pediatric patients, including children and older infants. However, special care is needed when using it in neonates (newborns) or very small infants, as the volume of fluid can impact their fluid and electrolyte balance. Premature neonates are particularly vulnerable due to their immature kidneys and the risk of aluminum accumulation, which can lead to toxicity. It's important to note that this product contains no more than 25 mcg/L of aluminum.

For any specific use, especially in neonates, always refer to the package insert of the solute being used and pay attention to warnings regarding aluminum and fluid volume.

Geriatric Use

When using Sterile Water, especially for irrigation, it's important to proceed with caution if you are an older adult. This is because older individuals may have decreased function in the heart, kidneys, or liver, which can affect how your body processes medications and fluids. While there are no specific dosage adjustments or safety concerns outlined for elderly patients, it's always wise to consult with your healthcare provider about your individual health status and any other medications you may be taking.

For any use of Sterile Water, particularly in conjunction with other medications, refer to the package insert of the solute being used, as there may be warnings regarding aluminum or other components that could be relevant to your health. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

When using Sterile Water for Injection or Solution, it's important to be aware that this product contains aluminum, which can be toxic, especially if you have impaired kidney function. Prolonged use may lead to aluminum accumulation, particularly in premature neonates whose kidneys are still developing. Research shows that receiving more than 4 to 5 micrograms of aluminum per kilogram per day can result in harmful effects on the central nervous system and bones.

If you have kidney problems, dosage adjustments may be necessary, and your healthcare provider should monitor your renal function closely. It's also advised to consider a reduced dose if your creatinine clearance is decreased. Additionally, if you're undergoing procedures that involve irrigation, be cautious, as patients with severe renal dysfunction may be at risk for complications related to fluid overload. Always consult your healthcare provider for personalized advice and monitoring.

Hepatic Impairment

You can rest assured that there is no specific information regarding liver problems (hepatic impairment) for Sterile Water or Bacteriostatic Water. This means that there are no dosage adjustments, special monitoring, or precautions needed for patients with liver issues when using these products.

If you have any concerns about your liver health or how it may affect your treatment, it's always a good idea to discuss this with your healthcare provider.

Drug Interactions

When using Sterile Water for injection or solution, it's important to be aware that some medications may not mix well together, especially if they are combined in the same container or if the container contains benzyl alcohol. To ensure safety and effectiveness, always consult with a pharmacist if you have questions about compatibility. Additionally, when adding any substances to Sterile Water, use proper aseptic techniques and check the solution for any visible particles or discoloration before use. Discussing your medications and any tests with your healthcare provider is crucial to avoid potential complications and ensure the best care.

Storage and Handling

To ensure the quality and safety of Sterile Water for Injection, store it at a temperature between 20°C to 25°C (68°F to 77°F). Avoid exposing it to freezing temperatures or excessive heat, as this can compromise the product. While brief exposure to temperatures up to 40°C (104°F) is acceptable, it's best to minimize heat exposure whenever possible.

This product is intended for single use only; any unused portion should be discarded. Always check that the solution is clear and the seal is intact before use. If you have any questions about disposal, please follow local regulations for disposing of medical waste.

Uses and Indications

Sterile Water for Injection, USP is indicated for use in the aseptic preparation of parenteral solutions and as a diluent or solvent for the preparation of intravenous admixtures. It is specifically indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy. This preparation is suitable for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection, according to the instructions of the manufacturer of the drug to be administered.

Additionally, Sterile Water for Injection may be utilized as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced. It is indicated for use in both adult and pediatric patients.

Sterile Water for Irrigation, USP is indicated for use as an irrigating fluid or pharmaceutic aid. It may also serve as an adjunct in the preparation of non-intravenously administered nutrient mixtures. This preparation is suitable for all general irrigation, washing, rinsing, and dilution purposes that permit the use of sterile, nonpyrogenic, solute-free water.

Limitations of Use

Sterile Water for Injection is not indicated for use in neonates.
AQUALITE™ is indicated for intraperitoneal, irrigation, and topical use only and is not for injection.

Dosage and Administration

Sterile Water for Injection, USP is intended for use in the preparation of sterile intravenous admixtures and should not be infused directly. The dosage is determined by the prescribing physician based on the patient's age, weight, clinical condition, and laboratory determinations.

When compounding admixtures, it is essential to use strict aseptic techniques. The preparation should be mixed thoroughly, and any unused portion must not be stored. After the initial entry into the container, the contents should be maintained at room temperature (25°C/77°F) and dispensed within 4 hours.

Parenteral drug products must be visually inspected for particulate matter and discoloration prior to administration whenever the solution and container permit. A final filter is recommended during the administration of all parenteral solutions when possible.

For the preparation of admixtures, the volume of Sterile Water for Injection used for diluting or dissolving any drug is dependent on the vehicle concentration, dose, and route of administration as recommended by the manufacturer. When introducing additives, the following steps should be adhered to: prepare the additive port, puncture the resealable additive port using an appropriate needle, inject the medication, and withdraw the needle. The container contents should be mixed thoroughly after the introduction of any additives.

During administration, the container must be stored and manipulated in an appropriate laminar flow hood. The outlet port cover should be removed, and the piercing pin of the transfer set should be inserted into the port with a twisting motion until securely seated. The container should be suspended, and the drip chamber should be filled to the proper level. The flow control clamp should be opened to clear air from the set before attaching it to the venipuncture device. The rate of administration should be regulated using the flow control clamp.

For irrigation purposes, the volume and rate depend on the procedure and the capacity or surface area of the structure being irrigated. Sterile Water for Irrigation, USP may also be used to prepare non-intravenously administered nutrient mixtures, which contain no electrolytes or added substances.

In all cases, consult with a pharmacist regarding the compatibility of any additives and follow the specific preparation instructions for the mixtures being used.

Contraindications

Sterile Water for Injection, USP is contraindicated for intravenous administration without the addition of a solute due to its hemolytic properties and hypotonicity. It must be made approximately isotonic prior to use to prevent adverse effects. Direct infusion is not permitted, and it should not be used for non-automated admixture preparations. Additionally, Sterile Water is not intended for injection by usual parenteral routes.

Bacteriostatic Water for Injection, which contains benzyl alcohol, is contraindicated in neonates due to the potential toxicity of benzyl alcohol. It should not be used for fluid replacement or in epidural or spinal anesthesia procedures.

Warnings and Precautions

Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis, which can lead to serious complications such as hemoglobin-induced renal failure. This solution is intended for dilution purposes only and should not be used for direct infusion. It is crucial to ensure that Sterile Water is adjusted to approximate isotonicity with a suitable solute before administration to mitigate the risk of hemolysis.

Serious Warnings

Toxicity of Aluminum: This product contains aluminum that may be toxic. Prolonged parenteral administration can lead to toxic levels, particularly in patients with impaired kidney function. Premature neonates are especially at risk due to their immature kidneys and the need for calcium and phosphate solutions that contain aluminum. Research indicates that patients receiving parenteral aluminum levels greater than 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Hypotonicity: Sterile Water for Injection is hypotonic and can cause hemolysis. It is not recommended for use during surgical procedures or for intravenous injection unless made isotonic.

Monitoring Requirements

Patients receiving intravenous solutions should be monitored for fluid and/or solute overload, which can result in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered solutions. Additional monitoring is recommended for patients at increased risk of complications from fluid overload syndrome, such as those with renal or cardiac impairment.

General Precautions

This solution is for compounding only and should not be used in series connection with plastic containers to avoid air embolism. If a pumping device is used for administration, it is essential to discontinue pumping before the container runs dry. The solution should only be used if clear and the container and seals are intact. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
After opening, the contents of Sterile Water for Irrigation should be used promptly to minimize the risk of bacterial growth or pyrogen formation. Discard any unused portion as it contains no preservative.

Laboratory Tests

No specific laboratory tests are mentioned; however, monitoring for absorption of clinically relevant amounts of fluid during and after procedures is advised.

Emergency Instructions

No specific instructions for emergency medical help or to stop taking and call a doctor are provided.

Side Effects

Reactions that may occur due to the administration of Sterile Water for Injection, USP, or the technique of reconstitution or administration include:

Serious Reactions:
- Hemolysis: Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis, which can lead to hemoglobin-induced renal failure.
- Fluid Overload: The administration of intravenous solutions can cause fluid and/or solute overload, resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered solutions.
Common Reactions:
- Febrile response
- Local tenderness
- Abscess
- Tissue necrosis or infection at the site of injection
- Venous thrombosis or phlebitis extending from the site of injection
- Extravasation
- Hypervolemia
Specific Populations:
- Premature neonates are particularly at risk for aluminum toxicity due to immature kidney function. Prolonged parenteral administration of aluminum can lead to toxic levels, especially if kidney function is impaired. Research indicates that patients with impaired kidney function who receive parenteral levels of aluminum greater than 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity.
Overdosage:
- Manifestations of water intoxication may include behavioral changes (confusion, apathy, disorientation), central nervous system disturbances (weakness, muscle twitching, headaches, nausea, vomiting, convulsions), and weight gain. In the event of overhydration or solute overload, re-evaluation of the patient and appropriate corrective measures should be instituted.
Warnings:
- This product is for dilution only and should not be used for direct infusion. It is essential to ensure that the solution is clear and the seal is intact before use. Aseptic technique is crucial when using sterile preparations for compounding admixtures.

Drug Interactions

Some formulations of Sterile Water, particularly those intended for injection, may present compatibility issues with certain drugs. It is important to note that some drugs may be incompatible when combined in the same vehicle or when used in a vehicle containing benzyl alcohol. Therefore, it is advisable to consult with a pharmacist when considering the use of Sterile Water for injection in conjunction with other medications.

Additionally, when introducing additives to Sterile Water, it is essential to employ aseptic techniques, ensure thorough mixing, and avoid storage of the mixture. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever the solution and container permit.

No specific drug interactions or laboratory test interactions have been documented for Sterile Water or Bacteriostatic Water.

Pediatric Use

Safety and effectiveness of Sterile Water have been established in pediatric patients, including children and adolescents. The clinical conditions in the pediatric population are considered similar to those in adults, supporting its use.

In neonates or very small infants, caution is advised as the volume of fluid administered may affect fluid and electrolyte balance. Premature neonates are particularly at risk due to immature kidney function and their need for large amounts of calcium and phosphate solutions, which may contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral aluminum levels greater than 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. This product contains no more than 25 mcg/L of aluminum.

For Bacteriostatic Water for Injection, USP, safety and effectiveness have not been established in pediatric patients. Solutions containing benzyl alcohol should not be used in neonates due to the potential for toxicity.

Pediatric patients are at higher risk for developing complications such as encephalopathy from hyponatremia if there is excessive absorption of Sterile Water for Irrigation.

Geriatric Use

Elderly patients may require cautious use of Sterile Water for Irrigation due to the potential for decreased cardiac, renal, or hepatic function, as well as the presence of other diseases or concomitant drug therapy. No specific information regarding dosage adjustments, safety concerns, or special precautions for geriatric patients is provided in the inserts for Sterile Water or Bacteriostatic Water. Healthcare professionals are advised to refer to the package insert of the solute used, particularly regarding warnings related to aluminum. Monitoring of geriatric patients is recommended to ensure safety and efficacy during treatment.

Pregnancy

Animal reproduction studies have not been conducted with Sterile Water for Injection, and it is not known whether sterile water containing additives can cause fetal harm when administered to pregnant patients or affect reproductive capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.

Sterile Water for Injection is classified as Pregnancy Category C, indicating that risk cannot be ruled out. There are no specific warnings, contraindications, or safety concerns mentioned regarding its use during pregnancy. However, it is important to consider that all pregnancies carry a background risk of birth defects, loss, or other adverse outcomes, with the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies being 2 to 4% and 15 to 20%, respectively.

Healthcare professionals should refer to the package insert of any solute used in conjunction with Sterile Water for Injection for additional information regarding its use in pregnant patients.

Lactation

Nursing mothers should be aware of the potential for excretion of Sterile Water in breast milk. There is an associated risk for breastfed infants when this medication is used during lactation, although specific data regarding its effects on nursing infants are not provided. Caution is advised when administering this medication to nursing mothers, particularly in the context of any additives that may be used with Sterile Water for Injection.

It is not known whether Sterile Water can affect breast milk production or the health of breastfed infants. Therefore, nursing mothers are encouraged to consult with their healthcare provider regarding the use of Sterile Water, especially if there are concerns about potential risks to their infants. The developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for this medication.

Renal Impairment

Patients with renal impairment may require careful consideration when using Sterile Water for Injection or Solution due to the potential toxicity of aluminum, which is present in these products. Prolonged parenteral administration of aluminum can lead to toxic levels, particularly in individuals with compromised kidney function. Research indicates that patients, including premature neonates, receiving parenteral aluminum at doses exceeding 4 to 5 mcg/kg/day are at risk of accumulating aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower administration rates.

For patients with reduced kidney function, dosage adjustments may be necessary, and renal function tests should be monitored closely. It is advisable to consider a reduced dose for those with decreased creatinine clearance. Additionally, caution is warranted in patients with severe cardiopulmonary or renal dysfunction, particularly when using solutions for urologic irrigation, as these patients are at increased risk of complications such as fluid overload syndrome. Avoiding procedures that require prolonged irrigation times or high irrigation fluid pressure is also recommended for patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment do not have specific dosage adjustments, special monitoring requirements, or precautions outlined for the use of Sterile Water or Bacteriostatic Water. The available information across multiple labels indicates that there are no known effects or necessary modifications in treatment protocols for this patient population. Therefore, healthcare providers may proceed with standard dosing and administration practices without additional considerations for hepatic function.

Overdosage

In cases of overdosage with Sterile Water, the primary concern is hypotonic expansion, which occurs when there is an increase in fluid intake that exceeds fluid output. This condition may arise in patients receiving large quantities of electrolyte-free water to compensate for excessive fluid losses, those whose renal tolerance to water loads is surpassed, or patients retaining water postoperatively due to stress.

Symptoms of water intoxication can include behavioral changes such as confusion, apathy, and disorientation, as well as central nervous system disturbances like weakness, muscle twitching, headaches, nausea, vomiting, and convulsions. Additionally, weight gain may be observed.

Management of overdosage involves withholding fluids until the excessive water is excreted. In cases of severe hyponatremia, it may be necessary to cautiously administer hypertonic saline to increase extracellular osmotic pressure and facilitate the excretion of excess water by the kidneys.

It is important to note that the intravenous administration of Sterile Water, particularly when used as a diluent or solvent, can lead to fluid and/or solute overload, resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the solutions used.

In neonates or very small infants, the risk of fluid overload is heightened, and any signs of overhydration or solute overload should prompt immediate re-evaluation of the patient and the implementation of appropriate corrective measures. Monitoring is particularly crucial for patients with impaired kidney function, as they are at increased risk for complications associated with aluminum toxicity and fluid overload.

Nonclinical Toxicology

Teratogenic Effects

Animal reproduction studies have not been conducted with Sterile Water for Injection. It is unknown whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. The product is classified as Pregnancy Category C.

Non-Teratogenic Effects

Prolonged parenteral administration of aluminum may lead to toxic levels, particularly in patients with impaired kidney function, including premature neonates. These patients are at increased risk due to immature kidney function and the requirement for large amounts of calcium and phosphate solutions, which may contain aluminum. Research indicates that parenteral levels of aluminum exceeding 4 to 5 mcg/kg/day can result in accumulation at levels associated with central nervous system and bone toxicity, with tissue loading potentially occurring at even lower rates of administration.

Nonclinical Toxicology

No specific nonclinical toxicology details are provided in the available data.

Animal Pharmacology and Toxicology

The safety of the plastic used for packaging has been confirmed by tests in animals according to USP biological standards for plastic containers. However, studies evaluating the carcinogenic potential, mutagenic potential, or effects on fertility of Sterile Water for Irrigation have not been performed.

Storage and Handling

Sterile Water is supplied in various forms, including Injection and Solution, in single-dose flexible plastic containers. The containers are non-PVC, non-DEHP, and do not contain natural rubber latex. Each container is sterile and designed for single-use only, with no preservatives added. Unused portions of vials should be discarded, and the solution should only be used if it is clear and the seal is intact.

The product should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), in accordance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing and to minimize exposure to excessive heat. While brief exposure to temperatures up to 40°C (104°F) does not adversely affect the product, it is recommended to avoid such conditions whenever possible.

For optimal handling, stock should be rotated frequently, and care should be taken to ensure that the product is not heated above 66°C (150°F).

Product Labels

The table below lists all FDA-approved prescription labels containing water. Use it to compare dosage forms, strengths, and approved indications across labels.

FDA-Approved Water Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.

Bacteriostatic Water Henry Schein, Inc.	Injection, Solution	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2022
Label Bacteriostatic WaterView full label details → Manufacturer Henry Schein, Inc. Form Injection, Solution Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2022 Indications diluting drugs for injection dissolving drugs for injection
Bacteriostatic Water Hospira, Inc.	Injection, Solution	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2005
Label Bacteriostatic WaterView full label details → Manufacturer Hospira, Inc. Form Injection, Solution Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2005 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water B. Braun Medical Inc.	Injection	Intravenous	1 mL/1 mL	2014
Label Sterile WaterView full label details → Manufacturer B. Braun Medical Inc. Form Injection Routes Intravenous Strength range 1 mL/1 mL FDA year 2014 Indications diluent for parenteral solutions sterile water for injection vehicle for drug administration
Sterile Water B. Braun Medical Inc.	Injection	Intravenous	1 mL/1 mL	1988
Label Sterile WaterView full label details → Manufacturer B. Braun Medical Inc. Form Injection Routes Intravenous Strength range 1 mL/1 mL FDA year 1988 Indications diluent for parenteral solutions sterile water for injection vehicle for drug administration
Sterile Water B. Braun Medical Inc.	Irrigant	Irrigation	100 mL/100 mL	2013
Label Sterile WaterView full label details → Manufacturer B. Braun Medical Inc. Form Irrigant Routes Irrigation Strength range 100 mL/100 mL FDA year 2013 Indications irrigating fluid nutrient mixture preparation pharmaceutic aid
Sterile Water B. Braun Medical Inc.	Irrigant	Irrigation	1 mL/1 mL	1970
Label Sterile WaterView full label details → Manufacturer B. Braun Medical Inc. Form Irrigant Routes Irrigation Strength range 1 mL/1 mL FDA year 1970 Indications irrigating fluid nutrient mixture preparation pharmaceutic aid
Sterile Water Baxter Healthcare Company	Injection, Solution	Intravenous	100 mL/100 mL	1982
Label Sterile WaterView full label details → Manufacturer Baxter Healthcare Company Form Injection, Solution Routes Intravenous Strength range 100 mL/100 mL FDA year 1982 Indications aseptic preparation of parenteral admixtures
Sterile Water Baxter Healthcare Company	Injection, Solution	Intravenous	100 mL/100 mL	1982
Label Sterile WaterView full label details → Manufacturer Baxter Healthcare Company Form Injection, Solution Routes Intravenous Strength range 100 mL/100 mL FDA year 1982 Indications aseptic preparation of parenteral solutions
Sterile Water Baxter Healthcare Corporation	Irrigant	Irrigation	100 mL/100 mL	1974
Label Sterile WaterView full label details → Manufacturer Baxter Healthcare Corporation Form Irrigant Routes Irrigation Strength range 100 mL/100 mL FDA year 1974 Indications sterile water for irrigation
Sterile Water Becton Dickinson and Company	Injection, Solution	Intravenous	1000 mL/1000 mL	2020
Label Sterile WaterView full label details → Manufacturer Becton Dickinson and Company Form Injection, Solution Routes Intravenous Strength range 1000 mL/1000 mL FDA year 2020 Indications diluent for injections parenteral fluid replenishment solvent for parenteral drugs
Sterile Water Becton Dickinson and Company	Injection	Irrigation	1 mL/1 mL	2025
Label Sterile WaterView full label details → Manufacturer Becton Dickinson and Company Form Injection Routes Irrigation Strength range 1 mL/1 mL FDA year 2025 Indications irrigating fluid nutrient mixture preparation pharmaceutic aid
Sterile Water Cardinal Health 107, LLC	Injection	Subcutaneous Intravenous Intramuscular	1 mL/1 mL	2024
Label Sterile WaterView full label details → Manufacturer Cardinal Health 107, LLC Form Injection Routes Subcutaneous, Intravenous, Intramuscular Strength range 1 mL/1 mL FDA year 2024 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Cardinal Health 107, LLC	Injection	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2011
Label Sterile WaterView full label details → Manufacturer Cardinal Health 107, LLC Form Injection Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2011 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Chartwell RX, LLC	Injection	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2021
Label Sterile WaterView full label details → Manufacturer Chartwell RX, LLC Form Injection Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2021 Indications IM drug dilution IV drug dilution subcutaneous drug dilution
Sterile Water Civica, Inc.	Injection, Solution	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2022
Label Sterile WaterView full label details → Manufacturer Civica, Inc. Form Injection, Solution Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2022 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Fresenius Kabi USA, LLC	Injection, Solution	Intravenous	1000 mL/1000 mL	2017
Label Sterile WaterView full label details → Manufacturer Fresenius Kabi USA, LLC Form Injection, Solution Routes Intravenous Strength range 1000 mL/1000 mL FDA year 2017 Indications parenteral fluid replenishment parenteral solvent sterile water for injection
Sterile Water Fresenius Kabi USA, LLC	Injection	Subcutaneous Intravenous Intramuscular	1 mL/1 mL	2000
Label Sterile WaterView full label details → Manufacturer Fresenius Kabi USA, LLC Form Injection Routes Subcutaneous, Intravenous, Intramuscular Strength range 1 mL/1 mL FDA year 2000 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Fresenius Kabi USA, LLC	Injection	Subcutaneous Intravenous Intramuscular	1 mL/1 mL	2022
Label Sterile WaterView full label details → Manufacturer Fresenius Kabi USA, LLC Form Injection Routes Subcutaneous, Intravenous, Intramuscular Strength range 1 mL/1 mL FDA year 2022 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Fresenius Kabi USA, LLC	Injection	Irrigation	1 mL/1 mL	2025
Label Sterile WaterView full label details → Manufacturer Fresenius Kabi USA, LLC Form Injection Routes Irrigation Strength range 1 mL/1 mL FDA year 2025 Indications irrigating fluid nutrient mixture preparation pharmaceutic aid
Sterile Water General Injectables and Vaccines, Inc.	Injection, Solution	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2019
Label Sterile WaterView full label details → Manufacturer General Injectables and Vaccines, Inc. Form Injection, Solution Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2019 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Henry Schein, Inc.	Injection, Solution	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2025
Label Sterile WaterView full label details → Manufacturer Henry Schein, Inc. Form Injection, Solution Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2025 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Henry Schein, Inc.	Injection	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2022
Label Sterile WaterView full label details → Manufacturer Henry Schein, Inc. Form Injection Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2022 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Henry Schein, Inc.	Injection	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2022
Label Sterile WaterView full label details → Manufacturer Henry Schein, Inc. Form Injection Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2022 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Hikma Pharmaceuticals USA Inc.	Injection, Solution	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2015
Label Sterile WaterView full label details → Manufacturer Hikma Pharmaceuticals USA Inc. Form Injection, Solution Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2015 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Hikma Pharmaceuticals USA Inc.	Injection, Solution	Intravenous	1 mL/1 mL	2023
Label Sterile WaterView full label details → Manufacturer Hikma Pharmaceuticals USA Inc. Form Injection, Solution Routes Intravenous Strength range 1 mL/1 mL FDA year 2023 Indications aseptic preparation of parenteral solutions
Sterile Water Hospira, Inc.	Injection	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2005
Label Sterile WaterView full label details → Manufacturer Hospira, Inc. Form Injection Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2005 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Hospira, Inc.	Injection	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2025
Label Sterile WaterView full label details → Manufacturer Hospira, Inc. Form Injection Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2025 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water ICU Medical Inc.	Injection, Solution	Intravenous	1 mL/1 mL	2019
Label Sterile WaterView full label details → Manufacturer ICU Medical Inc. Form Injection, Solution Routes Intravenous Strength range 1 mL/1 mL FDA year 2019 Indications intravenous admixtures preparation sterile water for injection
Sterile Water ICU Medical Inc.	Injection, Solution	Intravenous	1000 mL/1000 mL	2019
Label Sterile WaterView full label details → Manufacturer ICU Medical Inc. Form Injection, Solution Routes Intravenous Strength range 1000 mL/1000 mL FDA year 2019 Indications diluent for parenteral solutions intravenous administration solvent for parenteral drugs water for parenteral fluid replenishment
Sterile Water ICU Medical Inc.	Irrigant	Irrigation	1 mL/1 mL	2019
Label Sterile WaterView full label details → Manufacturer ICU Medical Inc. Form Irrigant Routes Irrigation Strength range 1 mL/1 mL FDA year 2019 Indications general irrigation nonpyrogenic water sterile water for irrigation
Sterile Water ICU Medical Inc.	Irrigant	Irrigation	1 mL/1 mL	2024
Label Sterile WaterView full label details → Manufacturer ICU Medical Inc. Form Irrigant Routes Irrigation Strength range 1 mL/1 mL FDA year 2024 Indications intraperitoneal irrigation isotonic irrigation solution sodium chloride irrigation sterile water for irrigation topical irrigation
Sterile Water Medefil, Inc.	Injection, Solution	Subcutaneous Intravenous Intramuscular	100 mL/100 mL	2020
Label Sterile WaterView full label details → Manufacturer Medefil, Inc. Form Injection, Solution Routes Subcutaneous, Intravenous, Intramuscular Strength range 100 mL/100 mL FDA year 2020 Indications diluting drugs for injection dissolving drugs for injection
Sterile Water Nephron Pharmaceuticals Corporation	Injection	Intravenous Subcutaneous Intramuscular	1 mL/1 mL	2021
Label Sterile WaterView full label details → Manufacturer Nephron Pharmaceuticals Corporation Form Injection Routes Intravenous, Subcutaneous, Intramuscular Strength range 1 mL/1 mL FDA year 2021 Indications diluting drugs for injection dissolving drugs for injection

Repacked & Relabeled Product Labels

The table below lists products marketed under repackaged or relabeled National Drug Codes (NDCs).

Only the carton or labeler has changed; the underlying FDA-approved SPL and prescribing information match the primary labels above, so no separate detail pages are provided.

Label

Forms

Routes

Water

FDA year

HF Acquisition Co LLC, DBA HealthFirst

Injection, Solution

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2019

Label: Bacteriostatic Water
Manufacturer: HF Acquisition Co LLC, DBA HealthFirst
Form: Injection, Solution
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2019

Packaging

Packaging configurations for Bacteriostatic Water.
				Details
	30 mL in vial, multi-dose 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of December 14, 2019) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL Inactive ingredients benzyl alcohol

Medical Purchasing Solutions, LLC

Injection, Solution

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2005

Label: Bacteriostatic Water
Manufacturer: Medical Purchasing Solutions, LLC
Form: Injection, Solution
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2005

Packaging

Packaging configurations for Bacteriostatic Water.
				Details
	1 in bag 30 mL in vial, multi-dose 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of March 30, 2018) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL Inactive ingredients benzyl alcohol

ProPharma Distribution

Injection, Solution

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2005

Label: Bacteriostatic Water
Manufacturer: ProPharma Distribution
Form: Injection, Solution
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2005

Packaging

Packaging configurations for Bacteriostatic Water.
				Details
	30 mL in vial, multi-dose 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of October 10, 2025) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL Inactive ingredients benzyl alcohol

US MedSource, LLC

Injection, Solution

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2014

Label: Bacteriostatic Water
Manufacturer: US MedSource, LLC
Form: Injection, Solution
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2014

Packaging

Packaging configurations for Bacteriostatic Water.
				Details
	1 in bag 30 mL in vial, multi-dose 1 item total	Injection, Solution	1 mL/1 mL
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 25, 2026 → status: Not marketed Active ingredients Water 1 mL/1 mL Inactive ingredients benzyl alcohol

A-S Medication Solutions

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2005

Label: Sterile Water
Manufacturer: A-S Medication Solutions
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2005

Packaging

Packaging configurations for Sterile Water.
				Details
	25 in tray 10 mL in vial, plastic 25 items total	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: NSDE file: March 25, 2026 → status: Active (as of February 17, 2017) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

Asclemed USA, Inc.

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2005

Label: Sterile Water
Manufacturer: Asclemed USA, Inc.
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2005

Packaging

Packaging configurations for Sterile Water.
				Details
	10 mL in vial, plastic 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of April 9, 2020) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

HF Acquisition Co LLC, DBA HealthFirst

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2018

Label: Sterile Water
Manufacturer: HF Acquisition Co LLC, DBA HealthFirst
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2018

Packaging

Packaging configurations for Sterile Water.
				Details
	50 mL in vial, plastic 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of September 17, 2018) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

HF Acquisition Co LLC, DBA HealthFirst

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2018

Label: Sterile Water
Manufacturer: HF Acquisition Co LLC, DBA HealthFirst
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2018

Packaging

Packaging configurations for Sterile Water.
				Details
	10 mL in vial, plastic 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of October 8, 2018) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

HF Acquisition Co LLC, DBA HealthFirst

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2019

Label: Sterile Water
Manufacturer: HF Acquisition Co LLC, DBA HealthFirst
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2019

Packaging

Packaging configurations for Sterile Water.
				Details
	20 mL in vial, plastic 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of December 14, 2019) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

HF Acquisition Co. LLC, DBA HealthFirst

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2018

Label: Sterile Water
Manufacturer: HF Acquisition Co. LLC, DBA HealthFirst
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2018

Packaging

Packaging configurations for Sterile Water.
				Details
	100 mL in vial, glass 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of September 2, 2018) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

Medical Purchasing Solutions, LLC

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2005

Label: Sterile Water
Manufacturer: Medical Purchasing Solutions, LLC
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2005

Packaging

Packaging configurations for Sterile Water.
				Details
	1 in bag 50 mL in vial, plastic 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of January 7, 2019) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

Medical Purchasing Solutions, LLC

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2005

Label: Sterile Water
Manufacturer: Medical Purchasing Solutions, LLC
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2005

Packaging

Packaging configurations for Sterile Water.
				Details
	1 in bag 10 mL in vial, plastic 1 item total	Injection	1 mL/1 mL
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 25, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

Medical Purchasing Solutions, LLC

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2005

Label: Sterile Water
Manufacturer: Medical Purchasing Solutions, LLC
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2005

Packaging

Packaging configurations for Sterile Water.
				Details
	1 in bag 20 mL in vial, plastic 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of June 3, 2022) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

ProPharma Distribution

Injection

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2005

Label: Sterile Water
Manufacturer: ProPharma Distribution
Form: Injection
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2005

Packaging

Packaging configurations for Sterile Water.
				Details
	50 mL in vial, plastic 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of August 27, 2025) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

ProPharma Distribution

Injection

Intravenous

1 mL/1 mL

1988

Label: Sterile Water
Manufacturer: ProPharma Distribution
Form: Injection
Routes: Intravenous
Strength range: 1 mL/1 mL
FDA year: 1988

Packaging

Packaging configurations for Sterile Water.
				Details
	500 mL in container 1 item total	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: NSDE file: March 25, 2026 → status: Active (as of September 18, 2025) Type Type 0: Not a Combination Product Active ingredients Water 1 mL/1 mL

TYA Pharmaceuticals

Injection, Solution

Intravenous
Subcutaneous
Intramuscular

1 mL/1 mL

2011

Label: Sterile Water
Manufacturer: TYA Pharmaceuticals
Form: Injection, Solution
Routes: Intravenous, Subcutaneous, Intramuscular
Strength range: 1 mL/1 mL
FDA year: 2011

Packaging

Packaging configurations for Sterile Water.
				Details
	25 mL in tray 1 item total	Injection, Solution	1 mL/1 mL
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 25, 2026 → status: Not marketed Active ingredients Water 1 mL/1 mL

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 49 FDA Structured Product Labels (DailyMed) for Water (marketed as Sterile Water, Bacteriostatic Water), with data retrieved March 26, 2026 by a validated AI data-extraction workflow. This includes 18 originator products, 15 generic products, and 16 repackaged/relabeled products. All FDA-approved dosage forms and strengths are aggregated in the sections above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (NDA016734, NDA017428, NDA017513, NDA017866, NDA018233, and 6 others). Complete prescribing information and detailed analysis for each product variant are accessible through the individual label pages linked in the product list above. No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update: March 26, 2026

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.