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General product information only, not medical advice. Follow the manufacturer’s labeling and your clinician’s direction.
Short answer
Anasept is a brand of skin and wound products from Anacapa Technologies, sold as a gel and a cleanser. FDA’s 510(k) database lists Anasept Antimicrobial Skin and Wound Gel and Cleanser under 510(k) K073547, with a decision date of 2008-04-23. “Cleared” is the correct word: a 510(k) is a substantial-equivalence clearance, not an FDA approval. The NLM AccessGUDID record for the cleanser describes a clear, isotonic liquid that delivers 0.057% sodium hypochlorite.
Definition and scope
This page covers the Anasept gel and cleanser as regulatory records describe them. It does not rate them against other products or recommend any use. Two sources are used: the AccessGUDID device record for the cleanser (catalog 4008SC, device identifier 00367180400885, read 2026-11-07) and the FDA 510(k) record K073547 (read 2026-11-07 through a mirror of FDA’s database).
What the records say it is for
The 510(k) record splits the indications by who is using the product. The table reproduces that split.
| Product | Over-the-counter indication | Professional indication |
|---|---|---|
| Gel | Skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin | Management of wounds such as pressure ulcers, diabetic foot and leg ulcers, post-surgical wounds, burns, and grafted and donor sites |
| Cleanser | Mechanical cleansing of dirt and debris from abrasions, minor irritations, cuts, exit sites and intact skin | Cleansing and removal of foreign material, including micro-organisms and debris, from wounds such as pressure ulcers, diabetic foot ulcers, post-surgical wounds, burns, and grafted and donor sites |
What is Anasept gel used for?
Per the 510(k) record, the over-the-counter gel is indicated for skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin. The professional gel is indicated for the management of wounds such as pressure ulcers, diabetic foot and leg ulcers, post-surgical wounds, burns, and grafted and donor sites. The current label on your product is the authority for use.
How the regulatory record classifies it
The AccessGUDID cleanser record lists the device as a wound irrigation solution with FDA product codes FQH (Lavage, Jet) and FRO (Dressing, Wound, Drug). The 510(k) record cites 21 CFR 880.5475 (jet lavage) and product code FRO. The record shows the device class inconsistently across the clearance letter and summary, so this page does not state a class.
For supply and quality staff, the GUDID record also carries these attributes for the cleanser: not packaged sterile, does not require sterilization before use, and storage marked “Do not freeze”. GUDID’s single-use field is recorded as “No”, while the device description text says the product cannot be reused after application. Follow the label on the specific product.
Common misunderstandings
Is wound cleanser an antiseptic?
Not by definition. The Anasept cleanser indications describe cleansing: removing dirt, debris and foreign material. The product name includes “Antimicrobial” and the active ingredient is sodium hypochlorite, but the indications above are what the clearance covers. For how FDA labels treat antiseptics, see Antiseptic for Wound Care: FDA Label Rules and Ingredients.
Is hydrogel the same as Anasept?
No. Hydrogel is a category of wound dressing, defined by what it is made of and how it functions. Anasept gel is a branded product cleared under the drug-dressing product code FRO, with an active ingredient given in its record. The two terms can describe different things even when both are gels. See What Is a Medical Dressing? for the dressing categories and What Is a Hydrofiber Wound Dressing? for a related dressing type.
What is equivalent to Anasept?
No source read for this page names an equivalent. “Equivalent” has a specific meaning in FDA terms: substantial equivalence is determined per 510(k) for a stated intended use, not by a similar name or ingredient. To compare any two products, compare their labeled indications and their own regulatory records. The wound and surgical irrigation supplies guide and the wound care pocket guide cover neighbouring product categories.
Where it matters for labs, clinics and supply decisions
- Check which indication applies. The over-the-counter and professional indications differ, and the record lists them separately for the gel and the cleanser.
- Record the device identifier. AccessGUDID entries are keyed by device identifier, and the same brand has more than one on file (00367180400885 and 00367180400045).
- Note that the cleanser is recorded as non-sterile. Staff who need a sterile irrigation product should confirm that attribute on the exact catalog item.
FAQ
Is Anasept FDA approved?
It is FDA 510(k) cleared (K073547, 2008-04-23). Clearance is not approval.
What is the active ingredient?
Sodium hypochlorite, at 0.057% in the cleanser per its GUDID record.
Is the cleanser sterile?
The GUDID record says it is not packaged sterile and does not require sterilization before use.
Sources
- NLM AccessGUDID, device record 00367180400885, accessgudid.nlm.nih.gov/devices/00367180400885, read 2026-11-07.
- FDA 510(k) K073547, Anasept Antimicrobial Skin and Wound Gel and Cleanser, Anacapa Technologies, decision 2008-04-23, via fda.innolitics.com/device/K073547 (mirror of the FDA database), read 2026-11-07.
