Bacteriostatic Water
1 mL/mL · Injection, Solution
- Prescription only
- Active substance
- Bacteriostatic Water
- Made by
- ProPharma Distribution
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-11-04
- This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
From the official label · 2025-11-04 · DailyMed
How it works
From this product’s own US prescribing label.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight.
Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-11-04
Do not take it if
- Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population.
- Parenteral preparations with benzyl alcohol should not be used for fluid replacement.
- Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures.
- Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
- See PRECAUTIONS .
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates.
- Data are unavailable on the toxicity of other preservatives in this age group.
- Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used.
- Intravenous administration of Bacteriostatic Water for Injection without a solute may result in hemolysis.
- Do not use Bacteriostatic Water for Injection, USP for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.
- Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.
- Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.
- Pregnancy :Animal reproduction studies have not been conducted with Bacteriostatic Water for Injection.
- It is also not known whether Bacteriostatic Water for Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Bacteriostatic Water for Injection, USP containing additives should be given to a pregnant woman only if clearly needed.
- Pediatric Use The safety and effectiveness of Bacteriostatic Water for Injection, USP have not been established in pediatric patients.
- Due to the potential for toxicity, solutions containing benzyl alcohol should not be used in neonates.
- Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol.
- Consult with pharmacist, if available.
- Use aseptic technique for single or multiple entry and withdrawal from all containers.
- When diluting or dissolving drugs, mix thoroughly and use promptly.
- Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.
- Do not use unless the solution is clear and seal intact.
Quoted from the official label, section “Warnings”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- Use only as a diluent or solvent.
- This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in very small infants.
- In the event these should occur, re-evaluate the patient and institute appropriate corrective measures.
- See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .
Quoted from the official label, section “Overdosage”.
Side effects
- Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.
- If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
- Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects.
- Administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Unit of Sale Benzyl Alcohol Preservative Concentration NDC 84549-977-03 Multiple-dose 30 mL plastic Fliptop vial 9 mg/mL
- Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Quoted from the official label, section “How Supplied”.
What is in it
- The following preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.
- Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) of benzyl alcohol added as a bacteriostatic preservative.
- It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection.
- The pH is 5.7 (4.5 to 7.0).
- Water for Injection, USP is chemically designated H 2 O.
- The semi-rigid vial is fabricated from a specially formulated polyolefin.
- It is a copolymer of ethylene and propylene.
- The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
- The container requires no vapor barrier to maintain the proper labeled volume.
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (4)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 4 of 4
- Bacteriostatic WaterThis onePrescription onlyProPharma DistributionNo ingredient list on the stored label
- Bacteriostatic WaterPrescription onlyFujian Genohope Biotech Ltd.No ingredient list on the stored label
- Bacteriostatic WaterPrescription onlyHF Acquisition Co LLC, DBA HealthFirstNo ingredient list on the stored label
- Bacteriostatic WaterPrescription onlyHospira, Inc.No ingredient list on the stored label
Details
| Made by | ProPharma Distribution |
|---|---|
| Active substance | Bacteriostatic Water |
| Strength | 1 mL/mL |
| Form | Injection, Solution |
| Route | Intramuscular; Intravenous; Subcutaneous |
| Packs | 30 mL in 1 VIAL, MULTI-DOSE |
| NDC | 84549-977 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
6 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Injection, Solution6 products
1 mL/mL6
1 mL/mL · 6 companies
- Fujian Genohope Biotech Ltd.
- Henry Schein, Inc.
- HF Acquisition Co LLC, DBA HealthFirst
- Hospira, Inc.
- Medical Purchasing Solutions, LLC
- ProPharma Distribution · this page
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.