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General product and regulatory information only, not medical advice. Wound care decisions belong to a clinician.
Short answer
Puracyn is a family of wound-care products from Oculus and later Innovacyn, cleared through FDA 510(k) notifications under product code FRO (“Dressing, Wound, Drug”). The Puracyn Plus irrigation solution contains purified water, hypochlorous acid and sodium phosphates. FDA’s summary describes the hypochlorous acid as a preservative of the solution, and cleansing as mechanical, from irrigation. Records read 2026-11-07.
Definition and scope
“Puracyn” is a brand name, not a chemical or a device class. Five FDA 510(k) records carry the name: K090206 (Puracyn Antimicrobial Skin and Wound Cleanser, cleared 2009-06-02, Oculus Innovative Sciences), K133542 (Puracyn Plus Skin and Wound, 2014-04-28, Innovacyn), K150799 (Puracyn Plus Duo-Care hydrogel and Professional Formula hydrogel, 2015-11-19), K232080 (Puracyn Plus Antimicrobial Irrigation Solution, 2024-05-31) and K251757 (same name, cleared 2026-01-05).
What are the ingredients in Puracyn?
The K251757 summary lists purified water, hypochlorous acid and sodium phosphates for the irrigation solution, which is a clear, colorless, sterile liquid. The K150799 summary describes the Professional Formula as an aqueous hydrogel thickened with nanoclay, with hypochlorous acid and sodium hypochlorite as preservatives. Always read the label of the specific pack in hand, because formulations differ by product and clearance.
How Puracyn works
For the irrigation solution, FDA’s K251757 summary says the formula “contains hypochlorous acid as an antimicrobial preservative to inhibit the growth of microorganisms within the solution”. Removal of dirt, debris and microorganisms is attributed to mechanical action and the hydrodynamic shear of irrigation. The indication is mechanical cleansing and removal of debris from wounds, including microorganisms. The summary reports testing to ISO 10993-1, USP chapter 51 (preservative effectiveness), USP chapter 71 (sterility), ISO 11607 and USP chapter 85 (endotoxin). In K150799 the free available chlorine inhibits microbial contamination within the gel product, and the hydrogel is described as maintaining a moist wound environment.
Types of wound cleansers: how the main cleared brands compare
Question: what are the different types of wound cleansers? In the 510(k) summaries read for this page, the brands separate by their active or preservative chemistry.
| Brand | Chemistry named in the 510(k) | Record | Form and packs named |
|---|---|---|---|
| Puracyn Plus | Hypochlorous acid (HOCl); sodium hypochlorite in the hydrogel | K251757 (2026); K150799 (2015) | Sterile irrigation, 1000 and 3000 mL bags; hydrogel |
| Microcyn | Water, sodium chloride, HOCl, sodium hypochlorite | K172622 (2017) | Clear hypotonic solution, non-sterile; also hydrogel K173896 (2018) |
| Vashe Plus | Saline-based, HOCl as preservative | K253665 (2026-08-11, Urgo Medical North America) | PET bottles of 118, 250, 475 and 1000 mL |
| Prontosan | Undecylenamidopropyl betaine and polyaminopropyl biguanide (PHMB) | K161623 (2016); wound gel K163430 (2017) | 40 mL ampoules, 350 mL squeeze bottle, 1000 mL |
| Anasept | Sodium hypochlorite | K073547 (2008) | Cleanser and gel |
Source: FDA 510(k) summaries and openFDA 510(k) records, read 2026-11-07. All five brands appear under product code FRO. Each brand’s own page covers its specific indications; see also the CASRAI guide to Anasept.
Microcyn, Anasept, Prontosan gel and hypochlorous acid wound products
Microcyn and Puracyn share hypochlorous acid and sodium hypochlorite as named components, but they are separate clearances from separate sponsors (Sonoma for K172622; Oculus then Innovacyn for Puracyn). Anasept is described in K073547 as containing sodium hypochlorite as its antimicrobial agent. Prontosan gel (K163430) belongs to the PHMB and betaine group, not the hypochlorous acid group. Vashe Plus is described as a saline-based cleanser with hypochlorous acid as a shelf preservative.
What is Hydrocyn Aqua used for?
No device named Hydrocyn Aqua appeared in the openFDA 510(k) device-name searches run for this page on 2026-11-07, so this page does not describe its use. Check the label and the manufacturer’s instructions for use for any product with that name.
Where it matters for labs, clinics and supply decisions
A supply or quality desk can confirm a product’s regulatory record without relying on marketing pages. Using the openFDA 510(k) endpoint (api.fda.gov/device/510k.json) or FDA’s 510(k) database, check these fields against the product label:
- Device name and K number: does the cleared name match the pack?
- Applicant: Oculus, Innovacyn, Sonoma, Urgo and B. Braun appear as different applicants across the records above.
- Product code and indications: FRO is a drug-containing wound dressing code; the indication text, for example “mechanical cleansing and removal of debris”, states what was cleared.
- Pack format: sterile bags, bottles, ampoules and non-sterile bottles are different presentations in different records.
- Prescription or over-the-counter marking: K172622 states supervision of a healthcare professional; the K251757 form shows both boxes.
For how a summary is structured, see the CASRAI guides to the 510(k) summary and FDA 510(k) data. For irrigation supplies in general, see wound and surgical irrigation supplies and antimicrobial wound dressings.
Common misunderstandings
- “Antimicrobial” does not mean the cleanser sterilises the wound. In K251757 the antimicrobial function is preservation of the solution itself; cleansing is attributed to irrigation.
- Puracyn is not one product. Cleanser, irrigation solution and hydrogel were cleared separately over 2009 to 2026.
- A 510(k) clearance is not an endorsement. It reflects a finding of substantial equivalence to a predicate; K251757 names K232080 as its predicate.
- Same chemistry does not mean same product. Packs, sterility and indications differ between Puracyn, Microcyn and Vashe records.
FAQ
How does Puracyn work?
Per FDA’s K251757 summary, hypochlorous acid preserves the solution against microbial growth, while irrigation provides mechanical cleansing and removal of debris and microorganisms.
What are the ingredients in Puracyn?
Purified water, hypochlorous acid and sodium phosphates for the Puracyn Plus irrigation solution; the hydrogel adds a nanoclay thickener and names sodium hypochlorite as well.
What are the different types of wound cleansers?
Among the cleared brands compared above: hypochlorous acid based (Puracyn, Microcyn, Vashe), PHMB with betaine (Prontosan) and sodium hypochlorite (Anasept).
What is Hydrocyn Aqua used for?
It is not covered here; no 510(k) device-name match was found in the search described above.
Sources
- FDA 510(k) K251757, Puracyn Plus Antimicrobial Irrigation Solution, read 2026-11-07.
- FDA 510(k) K150799, K172622, K253665, K161623 and K073547, read 2026-11-07.
- openFDA device 510(k) API and classification records for product code FRO, checked 2026-11-07.
