Ann: FDA Letter Requires Patient Instruction Update, page-104

I'm not sure on how the FDA regulations are laid out but I am assuming every topical product has to have a label saying to wash your hands after use. I am also sure there will be a regulation saying the applicator has to be labelled. This would mean whoever was in charge of submission just didn't read or understand the regulations. I could be wrong but the responses were so simple that I would expect a student intern to not much them up, let along an executive team with decades of FDA experience.

Further simplifying the instructions I can somewhat forgive as that is very interpretational. I wouldn't be surprised if the got the "applicator" and "wash you hands" right then the instructions wouldn't have been mentioned and we would have seen approval