Re: Labeling--Device is Rx in USA, non-Rx in EU
My understand would be that that won't work as a single label. Separate product versions for USA and EU, each with their own label, will be required.
It's conceivable that you might be allowed to use a label with something like
USA: Rx Only
EU: OTC
but my understanding is that both US FDA and EU authorities will jump on this approach as potentially confusing if/when they become aware of it.
You however could inquire directly to FDA, probably starting with DSMICA, if you wanted to pursue that direction.