Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury

Inclusion Criteria: * Are male or female and 18 to 75 years of age, inclusive. * Female patients of childbearing potential must practice abstinence or be using a medically acceptable form of contraception * Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 or Grade 2 sprain or strain), that has occurred within the 60 hours preceding the baseline visit. * Meet pain intensity criteria * Are willing to discontinue use of any pain medication or treatments not provided as part of the study. Exclusion Criteria: * Participation in a previous clinical study with the drug TDLP-110 (ketoprofen 10% cream). * Are pregnant or lactating. * Have a Grade 3 sprain or strain, bilateral sprain or strain, or concomitant fracture or open wound at the site of the sprain or strain, or have a serious injury, as determined by the investigator * Have a shoulder (rotator cuff) injury. * Have been treated for a sprain or strain of the same site within the past 3 months. * Have contusions at the site of acute soft tissue injury intended for treatment. * Have active skin lesions or disease at the intended site of application of the study medication. * Have had pharmacologic treatment for the injury less than 24 hours before the baseline assessments * Use of any oral or parenteral corticosteroids within 30 days of injury. * Have had non-pharmacologic treatments of the injury other than…