Eroxon (Topical Gel)
MED3000 Topical Evaporative ED Gel
Evidence grade 3 of 5, Mixed. Read how the Atlas grades evidence.
The written rationale for this grade is still being prepared.
- FDA
- FDA cleared OTC via de novo (June 2023)
Reference only. Not medical advice.
What can go wrong
Side effects are generally local and mild: headache, penile burning or irritation, and partner exposure to the gel. The marketed MED3000 contains no glyceryl trinitrate; GTN-containing topical formulations (not the cleared US product) would carry a theoretical risk of headache and hypotension and should not be combined with nitrates without guidance. Independent efficacy data are limited and the effect size has drawn scrutiny.
This is something to take to a clinician. The Atlas can tell you what is known about eroxon (topical gel) in general. It cannot tell you what is happening in your body, and the difference matters most for exactly the symptoms that bring people to this page.
Eroxon (MED3000) is a topical gel cleared by the FDA in June 2023 as the first over-the-counter treatment for erectile dysfunction, regulated as a medical device via the de novo pathway rather than as a drug. It is applied to the glans before intercourse; volatile solvents evaporate to produce a cooling-then-warming sensory stimulus intended to trigger erection through nerve stimulation and local nitric oxide release. The cleared US product is a non-medicated hydroalcoholic gel; an earlier Futura candidate (MED2005) was a glyceryl trinitrate (GTN) gel, but the marketed MED3000 contains no GTN.
The first FDA-cleared over-the-counter topical gel for erectile dysfunction.
What people take it for
These are the reasons people give for taking it. They are not effects it has been shown to have.
How it is supposed to work
The product works locally rather than systemically. Volatile solvents evaporate on the glans to create a rapid cooling sensation followed by warming, stimulating penile nerve endings and reportedly triggering local nitric oxide release and smooth-muscle relaxation to promote tumescence. The marketed MED3000 is non-medicated and is described as relying on this physical evaporative mechanism rather than on a drug; the predecessor GTN gel (MED2005) acted as a nitric oxide donor causing local vasodilation.
What people get wrong
Often saidEroxon is a topical Viagra
ActuallyIt is a sensory/topical device-classified product, not a PDE5 inhibitor; its effect size and durability are less established than oral PDE5 inhibitors.
Often saidOTC clearance means it is proven as effective as prescription ED drugs
ActuallyDe novo device clearance reflects a benefit-risk threshold for OTC use, not head-to-head superiority; independent efficacy questions remain.
Who profits, and who pushes back
Nobody is named here yet, because we have not done that work on this entry. Read that as unfinished. Somebody almost certainly sells this, and somebody almost certainly disputes it. Assume both until we have checked.
At a glance
- FDA clearance
- June 2023 (de novo, OTC)
- Regulatory class
- Medical device, not drug
- Application
- Glans, ~15 sec rub, before intercourse
- Onset
- Within ~10 minutes in trials
- Age label
- Adult males
What this entry does not yet cover
What follows is unfinished work on our side, not a finding about Eroxon (Topical Gel). A short entry is not a safe entry.
- Cost and market. We have not documented what it sells for or who sells it.
- Supply chain. We have not mapped where it is made.
- Who uses it. We have not documented the user groups.
- What could change. No forward-looking summary yet.
- How it compares. We have not set it against the alternatives.
- Children and teenagers. We have not checked what is known about younger people.
Sources
The studies below are named and described, but not linked. You cannot open them from here and check our reading against them, which means this page is our summary of the literature rather than a document you can verify. Weigh it accordingly until the links exist.
The studies that matter
Futura/manufacturer phase III program2022
Company-sponsored trials reported improvement in erectile function; independent replication and effect-size data remain limited
FDA de novo clearance2023
Granted OTC marketing authorization as a first-in-class topical ED device