Hub · Bacteriostatic Water
What is bacteriostatic water (BAC water)?
Bacteriostatic water is sterile water that contains 0.9% or 1.1% benzyl alcohol, added as a preservative to limit bacterial growth in multiple-dose vials (US label, DailyMed, read 14 October 2026). The label classes it as a drug diluent and bars its use in neonates. Its pH is stated as 5.7, within a range of 4.5 to 7.0.
About 70% of your body weight is water, a figure that US water labels print in their clinical text. Pharmacy water is still a different thing from the water in you. It has a grade, a container, a pH and a warning panel, and each of those is written down.
This page is part of the bacteriostatic water hub and answers, from the labels and from published studies, what is in a vial sold as bacteriostatic water. Bacteriostatic water vs sterile water covers the near neighbours. The page gives no preparation or use directions, and research material is not for human or animal use.
Key facts
| Name on label | Bacteriostatic Water, USP (the full labelled name adds a route phrase) |
|---|---|
| Composition | Water with 0.9% or 1.1% benzyl alcohol (US label) |
| pH | 5.7, range 4.5 to 7.0 (six full labels) |
| Containers | Multiple-dose vials: 30 mL plastic (0.9%) and 20 mL glass (1.1%) (US label) |
| Labelled category | Drug diluent (US label) |
| Key warning | Not for use in neonates (newborns) |
| Storage on labels | A room-temperature statement; no refrigeration statement |
| US marketing record | Application NDA018802 (six full labels); 'unapproved drug other' (one listing dated 25 June 2026) |
| DailyMed records read | 7 bacteriostatic water records; 6 with full label text |
| Facts checked | 14 October 2026 |
What is bacteriostatic water?
Bacteriostatic water is sterile, nonpyrogenic water with benzyl alcohol added as a bacteriostatic preservative. Bacteriostatic describes a preservative that limits the growth of bacteria, and CDC says such preservatives give no complete protection against contamination (CDC, 26 March 2024). The US label gives the benzyl alcohol content as 0.9% or 1.1% and describes a multiple-dose container (DailyMed, read 14 October 2026). 'BAC water' is informal shorthand for the same product, and nonpyrogenic means free of fever-causing contaminants.
The full label name adds a route phrase that this page leaves out, because the page gives no directions for any route. The USP in the label name is the United States Pharmacopeia, the book of official drug-quality standards.
What does bacteriostatic water contain?
Bacteriostatic water contains water and benzyl alcohol. The label reviewed lists the benzyl alcohol content as 0.9% in its 30 mL plastic vials and 1.1% in its 20 mL glass vials, and describes the water component as chemically H2O (DailyMed, read 14 October 2026). Benzyl alcohol is an aromatic alcohol with the formula C7H8O, and the body metabolises it into benzoic acid (EMA, 9 October 2017). The label names benzyl alcohol as the one bacteriostatic agent and lists no salt, so bacteriostatic water is not saline.
Benzyl alcohol turns up in other products too. EMA says it is used as an excipient (an ingredient other than the active substance) for its preservative properties, as a solubilising agent or as a fragrance, and that it appears in medicines given into muscle, into veins and on the skin (EMA, Questions and answers on benzyl alcohol used as an excipient, EMA/CHMP/508188/2013, 9 October 2017).
Is bacteriostatic water sodium chloride?
No. Bacteriostatic water contains no sodium chloride, while saline is sodium chloride dissolved in water. The bacteriostatic sodium chloride label reviewed describes a sterile, isotonic (close to the particle concentration of body fluids) solution of sodium chloride in WFI that also contains 0.9% benzyl alcohol, and the plain 0.9% sodium chloride labels (second record) describe the same salt solution without a preservative, with an osmolarity of 308 mOsmol/L (DailyMed, read 14 October 2026). Saline is therefore salt water of a controlled strength made with sterile water, and '0.9 sodium chloride' is simply that strength written another way.
What pH is bacteriostatic water?
The six full DailyMed labels for bacteriostatic water (8 July 2026, 17 November 2025, 17 November 2025, 10 January 2025, 23 May 2023 and 7 July 2014), one from the manufacturer and five from repackagers, each state a pH of 5.7 within a range of 4.5 to 7.0 (read 14 October 2026). On the pH scale 7 is neutral, so 5.7 is mildly acidic. The figure is a product specification for the finished vial. The labels set no pH target for anything else, and no source read for this page gives one. The figure describes the water as supplied in the sealed vial, not any solution made later by adding something to it.
What do DailyMed labels say about bacteriostatic water?
DailyMed lists seven bacteriostatic water records as of 14 October 2026: six with full label text and one, dated 25 June 2026, that carries a supply description and the marketing category 'unapproved drug other'. The six full labels share one text. They carry a drug-diluent category and a neonate contraindication, warn that hemolysis may result when the water is given into a vein without a solute, and carry a room-temperature storage statement. The six records name marketing application NDA018802.
DailyMed is the US National Library of Medicine's database of drug labels. The regulatory status page sets out the US and Australian records with their dates.
How can you tell whether bacteriostatic water has gone bad?
No label read for this page describes a test for spoiled bacteriostatic water, and its vial label prints lot and expiry fields (DailyMed, read 14 October 2026). CDC says a vial preservative gives no complete protection against bacterial contamination (CDC, 26 March 2024). Contamination of opened multi-dose vials has been measured in hospital surveys of mixed medicines, none of which tested bacteriostatic water, and each result is reported separately below.
In a one-day survey at a 1300-bed hospital in November 2001, 1 vial and 1 spike among 227 opened multi-dose vials of mixed medicines were contaminated, only 114 of the vials had an opening date marked, and the survey did not test bacteriostatic water or measure infections (Mattner and Gastmeier, American Journal of Infection Control, 2004). In a four-month survey at one Iranian teaching hospital, 36 of 637 used multidose vials held bacteria, mostly organisms that normally live on people, and the authors wrote that the clinical significance was not resolved (Motamedifar and Askarian, American Journal of Infection Control, 2009).
In a two-month survey at one Iranian pulmonary teaching hospital, 11 of 205 opened single- and multiple-dose vials were contaminated, and the survey did not test bacteriostatic water (Baniasadi et al., Brazilian Journal of Infectious Diseases, 2013). In a cross-sectional study of 384 parenteral medications at one Ethiopian medical centre in 2021, 21 multiple-dose vials and none of the single-dose vials were contaminated, and the study did not test bacteriostatic water (Tabor et al., Infection Prevention in Practice, 2023). Each survey sampled mixed hospital stocks, so none describes bacteriostatic water.
Can old or contaminated bacteriostatic water make you sick?
Contaminated multi-dose vials have caused infections in documented outbreaks, but no outbreak report read for this page names bacteriostatic water. A 2019 outbreak analysis described acute hepatitis C in 12 patients who received a saline flush from one multi-dose vial after a CT scan, found that viral sequences from 7 of the patients clustered closely with the suspected source patient, and concerned saline, not bacteriostatic water (Shteyer et al., PLoS One, 2019). A 2013 outbreak report from one Cambodian hospital recorded Burkholderia cepacia bloodstream infections in eight adult patients, three of whom died, whose catheters were flushed from a Ringer lactate bag used as a multiple-dose vial, and concerned Ringer lactate, not bacteriostatic water (De Smet et al., Clinical Microbiology and Infection, 2013).
Whether an old vial carries more risk than a new one is a separate question that those reports do not answer. The US label's adverse-reaction list names infection at the entry site among reactions that may occur because of the solution, an added drug or the technique used (DailyMed, read 14 October 2026). How long bacteriostatic water lasts covers the dates.
Does bacteriostatic water sting or burn?
No study read for this page measured stinging or burning from bacteriostatic water itself. The cited pain trials examined bacteriostatic saline, a different product from bacteriostatic water. In a trial of 221 participants randomly assigned by lottery convenience sampling to lidocaine, bacteriostatic saline or no local anaesthetic, bacteriostatic saline was less painful to place than lidocaine and both were effective as local anaesthetics, and the trial tested bacteriostatic saline, not bacteriostatic water (Windle et al., Journal of Perianesthesia Nursing, 2006). In a randomised, double-blind study of 148 adults, buffered lidocaine reduced catheter pain significantly more than bacteriostatic saline (P = 0.007), and the study tested bacteriostatic saline, not bacteriostatic water (Burke et al., American Journal of Nursing, 2011).
Those findings concern a different product and a different question from water in a vial, so they do not show whether bacteriostatic water burns. What labels and studies report covers the pain studies in more detail.
Evidence limits
What has not been shown about bacteriostatic water?
No clinical trial of bacteriostatic water as a product was among the sources read for this page. The evidence is the label, regulator guidance and studies of related products. A label states specifications and warnings. It does not show what any single vial holds after opening, and the studies of opened vials sampled mixed hospital vials, not bacteriostatic water alone. The US labels name no peptide and no research use, and no source read covers research material. Records were read on 14 October 2026, and later records may differ.
FAQ
Is bacteriostatic water FDA approved?
Six DailyMed listings with full label text (8 July 2026, 17 November 2025, 17 November 2025, 10 January 2025, 23 May 2023 and 7 July 2014) name marketing application NDA018802, a US new drug application number. A listing dated 25 June 2026 carries the category 'unapproved drug other' (DailyMed, read 14 October 2026).
Is bacteriostatic water the same as sterile water?
No. Bacteriostatic water holds benzyl alcohol as a preservative and sterile water holds none, according to the US bacteriostatic water and sterile water labels (DailyMed, read 14 October 2026).
Is bacteriostatic water regulated in Australia?
The October 2026 Poisons Standard (F2026L01327, read 14 October 2026) has no standalone entry for water or benzyl alcohol, and its only benzyl alcohol entry is the combined 'tannic acid/benzyl alcohol product' in Appendix B, clause 3. The TGA register holds sterile water products, for example ARTG 198332, a 5 mL ampoule with an ARTG date of 30 April 2013 (TGA, read 14 October 2026). Neither a missing named entry nor one ARTG example decides whether another product is lawful. The regulatory status page sets out the records.
Is 0.9 sodium chloride just saline?
Yes. The 0.9% sodium chloride labels (second record) describe a sterile, nonpyrogenic solution of sodium chloride in WFI with an osmolarity of 308 mOsmol/L, and saline is the name for that kind of solution (DailyMed, read 14 October 2026).
Is saline water just salt water?
Saline is salt water of a controlled strength made with sterile pharmacy-grade water. Two saline labels (second) describe it as a parenteral fluid and electrolyte replenisher (DailyMed, read 14 October 2026).
More in this hub
- Bacteriostatic water vs sterile water: what is the difference?
- Bacteriostatic water storage: what labels say about the fridge, freezing and expiry
- Bacteriostatic water: US labels, marketing status and Australian rules
- Is bacteriostatic water just sterile water? Label specifications and tests compared
- How long does bacteriostatic water last? Unopened, opened and in the fridge
- What is bacteriostatic water used for? What labels and studies report
- Bacteriostatic water side effects: what labels, regulators and studies record
Citations
8 sourcesWindle PE et al. Journal of PeriAnesthesia Nursing. 2006;21(4):251-258 — bacteriostatic normal saline vs lidocaine as intradermal anesthesia for intravenous lines.
doi:10.1016/j.jopan.2006.05.007Burke SD et al. American Journal of Nursing. 2011;111(2):40-45 — local anesthesia before IV catheterization.
doi:10.1097/01.NAJ.0000394291.40330.3cMattner F, Gastmeier P. American Journal of Infection Control. 2004;32(1):12-16 — bacterial contamination of multiple-dose vials.
doi:10.1016/j.ajic.2003.06.004Motamedifar M, Askarian M. American Journal of Infection Control. 2009;37(9):773-777 — multidose vial contamination in a teaching hospital, Shiraz.
doi:10.1016/j.ajic.2008.12.009Baniasadi S et al. Brazilian Journal of Infectious Diseases. 2013;17(1):69-73 — microbial contamination of vials after opening.
doi:10.1016/j.bjid.2012.09.005Tabor A et al. Infection Prevention in Practice. 2023;5(3):100290 — contamination of vials after opening, Jimma.
doi:10.1016/j.infpip.2023.100290Shteyer E et al. PLoS One. 2019;14(1):e0210173 — hepatitis C outbreak linked to a multi-dose saline vial.
doi:10.1371/journal.pone.0210173De Smet B et al. Clinical Microbiology and Infection. 2013;19(9):832-837 — Burkholderia cepacia outbreak from a multiple-dose use bag.
doi:10.1111/1469-0691.12047
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Research compound catalogue — supplied for laboratory research onlyResearch use only — not for human or animal use.
Read the bacteriostatic water hubForm Laboratories supplies research-use-only reference material. This article is an educational summary of published third-party literature. It is not medical advice, not a use instruction, and research material is not for human or animal use.
