Thanks for your quick response.
Its a product that we are only now wanting to take to the US market and are struggling to find space to fit it on the inner pack label along with all the other information needed.
Is it written in stone that it needs to be on both? My thoughts are that as the product will still be double wrapped when chosen / selected by the surgeon for a procedure and taken to theatre and will therefore still show the warning, once in theatre it will be taken out of the outer pack but the warning isnt relevent any more and dosent need to be on the inner pack.
I hope I'm making some sense!