Age: 18 - 65
Healthy Volunteers: Not accepted
Inclusion Criteria:
1. Acute soft-tissue injury/contusion.
2. Enrollment within 6 hours of the injury.
3. Baseline NRS score for POM of injured location >5 score points on an 11-point NRS.
4. Size of injury, as assessed by the investigator, ≥25 cm2 and ≤120 cm2
5. Adult male or female patients aged ≥18 years.
6. Having given written informed consent.
7. Satisfactory health as determined by the investigator based on medical history and physical examination.
Exclusion Criteria:
1. Significant concomitant injury in association with the acute injury; e.g., fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound.
2. Excessively hairy skin at application site, cutting the hair in the injured site prior to gel application will qualify for inclusion.
3. Current skin disorder or shaving hair at application site.
4. History of excessive sweating/hyperhidrosis inclusive of application site.
5. Treatment with topical or systemic NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study.
6. Intake of long-acting NSAIDs or application of topical medication since the injury (rest-ice-compression-elevation \[RICE\] is allowed).
7. Participation in a clinical study within 30 days before inclusion in the study or concomitantly.
8. Positive drug or alcohol screen or evidence of drug or alcohol abuse in the opinion of the investigator.
9. Pregnant or lactating or intending to become pregnant during the study.
10. Individuals of reproductive potential who do not agree to use of an acceptable birth control method throughout the study, when engaging in any sexual activity that comes with a risk of pregnancy.
11. History of any allergy or hypersensitivity (e.g., anaphylaxis, urticaria/hives, rhinitis, skin reaction, asthma, angioedema, or other allergic symptoms) to acetaminophen, ibuprofen, other NSAIDs, or to 1 of the excipients of the gel.
12. History of severe cutaneous adverse reactions to any medication, such as Stevens-Johnson syndrome (SJS), erythema multiforme, toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis.
13. Any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of S-ibuprofen gel 5%.
14. History of previous significant injury to the same extremity within 6 months.
15. Patients with a disease affecting the same area, such as synovitis, rheumatoid arthritis, arthrosis, etc.
16. Patients experiencing symptoms of an infectious disease including swelling of any joint of the affected area.
17. Patients having an ongoing painful condition associated with the injury/contusion.
18. Patients who had surgery of the affected area within 1 year of study entry.
19. Patients with significant diseases (defined as a disease which, in the opinion of the investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study; including patients with a history of gastrointestinal bleeding, significant cardiovascular, liver, or renal disease).
20. Patients with a blood coagulation disorder.
21. Patients who use any impermissible medication (eg. systemic or topical NSAIDs, analgesics (other than paracetamol), opiods, corticosteroids (except for topical treatment of bronchial asthma, heparin, or psychotropic agents)
22. Patients who participated in previous clinical studies of S-ibuprofen gel 5% and patients of the same household.
23. Patients who are related to those persons involved directly or indirectly with the conduct of the study.