Ann: Presentation- FDA Letter Requires Patient Instruction Update, page-43

I guess so, but the instructions to wash your hands are on the leaflet. I suppose the FDA may be thinking that the leaflet may get lost and that's why they want it on the bottle and box? But why was this not brought up in the six meetings they had to discuss the leaflet?? That's what seems so annoying to me, it's like the guy that makes the final decision wasn't even at the meetings, or he would have maybe mentioned it.

I've got shares in another company where the FDA has rejected a drug until the company can prove that nothing leaches out of the GLASS bottle that the drug is in! It's a liquid mixture of Paracetamol and ibuprofen, so not exactly likely to cause glass to dissolve. Now the company has to run tests to prove that glass is a safe! FFS.