Simple list of things to rectify:
1. Label gel applicator with “applicator”
2. Reformat the Instructions For Use so that it does not fold and “revise” theInstructions to further simplify the guidance for application
3. Place the statement “wash hands with soap and water immediately after use”on the outside of the carton and on the bottle prominently
4. Conduct another human factors validation study to demonstrate the revisedInstructions For Use are capable of being followed to be able to applySofpironium Bromide gel safely and effectively.
Wait time 3 to 6 months. maybe just 3 !
Ann: FDA Letter Requires Patient Instruction Update, page-67
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