Comment from Richard Cooke

P&G is seeking clarification from CPSC for a specific package form that was not considered in the briefing documents provided by CPSC in the Docket as background material (“Update of the technical feasibility, practicability, and appropriateness assessment of child-resistant and senior-friendly packages for imidazoline-containing household products,” dated January 11, 2012). This package is a glass bottle which houses the imidazoline drug product, with a crimped seal holding the pump in place and with an detachable nozzle (additional details and images are provided in the uploaded attachment to this submission). Drug product can only be dispensed from the bottle when the nozzle is attached over the pump. Actuation requires a degree of dexterity on the part of the user, typically requiring placement of the index and middle fingers on either side of the rim of the actuator nozzle and then placement of the thumb under the base of the bottle. The index and middle fingers are pushed down causing the actuator to be pushed down over the pump of the bottle and product is released. Should such a package be placed in a child resistant test protocol , P&G is seeking clarification from CPSC as to what would constitute a failure threshold, based on the number of actutations for a given concentration of imidazoline and specific amount of imidazoline per actutation (calculations are provided in the uploaded attachment to this submission).