definiens: means a sterile topical patch, for sale over - the - counter and is not for sale by prescription, that is not covered by one or more claims of the C assel Patents ( as defined on Schedule 1.20 ) and that is for use in human beings containing an active pharmaceutical ingredient with analgesic activity in an amount less than or equal to the amount permitted under the tentative final monograph for external analgesic drug products published by the FDA in the Notice of Proposed Rulemaking dated February 8, 1983 as it exists as of the Effective Date, either alone or in combination with one or more other active pharmaceutical ingredients . For purposes of clarity, an OTC Product does not include : ( a ) a sterile topical patch for use in non -human animals containing an active pharmaceutical ingredient with analgesic activity either alone or in combination with one or more other active pharmaceutical ingredients ; ( b ) a sterile topical patch for sale by prescription containing an active pharmaceutical ingredient with analgesic activity either alone or in combination with one or more other active pharmaceutical ingredients ; ( c ) a sterile topical patch for sale over -the - counter containing an active analgesic pharmaceutical ingredient in an amount that is higher than the tentative final monograph for external analgesic drug products published by the FDA in the Notice of Proposed Rulemaking dated February 8, 1983 as it exist s as of the Effective Date ; or ( d ) a sterile topical patch containing an active pharmaceutical ingredient with analgesic activity for use with surgically closed wounds