There was no missing leaflet. The issue was the instructions developed didn't include a reference to wash hands with soap and water after use. The FDA want that warning on the instructions and on the box. The other issue was they want the word 'applicator' printed on the applicator.
The FDA expert in the webinar mad it clear that this was a bit unusual. But at least the actual drug is hunky dory.
webinar, page-38
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