definiens: means a sterile topical patch for use solely in human beings containing an active pharmaceutical ingredient with analgesic activity either alone ( including without limitation the LidoPAIN(R ) SP Product ) or in combination with one or more other active pharmaceutical ingredients other than an OTC Product . For purposes of clarity, a Licensed Product : ( a ) does not include ( i ) 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, ( ii ) an OTC Product, or ( iii ) a non -sterile topical patch product ; and ( b ) does include a product that contains an active analgesic pharmaceutical ingredient 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 if such product is labeled for sale by prescr iption