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

Inclusion Criteria: * 18 to 70 years of age * Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity that has occurred within the 72 hours preceding the baseline visit. * The injury site must be accessible to the patient so that he or she can apply the study treatment himself or herself. * Meet pain entry criteria. * Willing to discontinue use of any pain medication or treatments not provided as part of the study. Exclusion Criteria: * 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 (e.g., nerve damage, joint instability, or tendon rupture). * Previous injury to the same area within 3 months prior to current injury. * Active skin lesions or disease at the intended site of application of the study medication. Skin lesions include open wounds, rash, papules, vesicles, and erythema associated with the site of injury. * Pharmacologic treatment (NSAIDs or analgesic medications) for the injury less than 12 hours before the baseline assessments. * Any form of opioid use since the time of injury. * Any form of steroid use within 30 days prior to study entry. * Non-pharmacologic treatments of the injury other than rest, ice, compression, and/or elevation (RICE) prior to the baseline visit. * History or physical examination finding that is not compatible with safe participation in the study as determined by t…