Terms of Use

Last Updated: November 2025

Welcome 

Welcome to the official website for Licart® (diclofenac epolamine) topical system 1.3%, operated by Acertis Pharmaceuticals LLC (“Acertis,” “we,” “our,” or “us”). These Terms of Use (“Terms”) govern your access to and use of this website (the “Site”). Please read these Terms carefully before using the Site. By accessing or using the Site, you acknowledge that you have read, understood, and agree to be bound by these Terms and all applicable laws and regulations. If you do not agree to these Terms, please do not use this Site. 

1. Purpose of the Site 

This Site is intended to provide general information about Licart and related educational materials. The Site may contain sections designed for healthcare professionals (HCPs) and patients. Content intended solely for HCPs will be clearly labeled. Patients should not rely on any information on this Site as a substitute for professional medical advice, diagnosis, or treatment. 

2. No Medical Advice 

The information provided on this Site is for educational purposes only and is not intended to replace the advice, diagnosis, or treatment of a qualified healthcare professional. Always seek the advice of your physician or other licensed health provider with any questions you may have regarding a medical condition or treatment. Never disregard or delay seeking professional medical advice because of something you have read on this Site. 

3. Product Information 

Licart is a prescription medication approved by the U.S. Food and Drug Administration (FDA). Licart is available upon prescription from a medical doctor or qualified medical professional only and may not be available in all countries. Product information provided on this Site is consistent with U.S. labeling and intended for audiences within the U.S. only. Accessing this Site from outside the U.S. is at your own risk, and users are responsible for compliance with local laws. 

4. Privacy Policy 

Your privacy is important to Acertis. When you visit this Site, we may collect certain limited information such as your IP address, browsing behavior, or voluntarily submitted contact details. We use this information solely for Site functionality, for analytics, and to improve user experience. We do not sell or share your personal information with third parties except as required by law or to comply with legal processes. By using this Site, you consent to the collection and use of your information as described in this section. 

5. Intellectual Property 

All content on this Site—including text, graphics, logos, icons, images, videos, software, and design elements—is owned or licensed by Acertis and protected under applicable copyright, trademark, and intellectual property laws. “Acertis” and related trademarks, logos, and trade dress are the property of Acertis. “Licart®” and related trademarks, logos, and trade dress are the property of Acertis’s licensor, IBSA Pharma Inc. or its affiliates. You may view and download materials from this Site for personal, non-commercial use only. Any unauthorized reproduction, distribution, or modification is expressly prohibited. 

6. User Conduct 

You agree not to: 
– Use this Site in violation of any law or regulation
– Upload, transmit, or distribute any viruses, malware, or harmful code
– Attempt to gain unauthorized access to the Site or its systems
– Misrepresent your identity or affiliation when using this Site; Acertis reserves the right to restrict or terminate access to the Site for any user who violates these Terms

7. Links to Third-Party Websites 

This Site may contain links to third-party websites for your convenience. These links are provided for informational purposes only. Acertis does not control or endorse, and is not responsible for, the content or privacy practices of any third-party sites. Your use of such sites is at your own risk. 

8. Limitation of Liability 

To the fullest extent permitted by law, Acertis, its affiliates, officers, directors, employees, and agents are not liable for any damages (including direct, indirect, incidental, consequential, or punitive damages) arising out of or related to your access to, or use of, or inability to use this Site or any errors or omissions related to its content. 

9. Indemnification 

You agree to indemnify, defend and hold harmless Acertis, its affiliates, and their respective officers, director, employees, and agents from any claims, damages, losses, liabilities, or expenses (including, without limitation, attorneys’ fees) arising out of your access to, use of, or inability to use the Site, or any errors or omissions in the content thereof, or your violation of these Terms. 

10. Changes to Terms 

Acertis may update or modify these Terms from time to time without prior notice. The “Last Updated” date at the top of this page reflects the most recent revision. Continued use of the Site after changes are posted constitutes acceptance of the revised Terms. 

11. Governing Law 

These Terms are governed by and construed in accordance with the laws of the State of North Carolina, without regard to its conflict of law principles. Any disputes arising under or relating to these Terms shall be resolved in the appropriate state or federal courts located in that state. 

12. Contact Us 

If you have any questions about these Terms or the Site, please contact: 
 
Acertis Pharmaceuticals LLC
Attn: Customer Support 
333 Fayetteville Street, Suite 1250 
Mailbox #A-14
Raleigh, North Carolina 27601 
Email: info@acertisrx.com  

13. Disclaimer 

This website may include forward-looking statements based on current expectations, which are subject to risks and uncertainties, including, but not limited to, statements with respect to the safety, efficacy, and potential benefits of Licart. Actual results may differ materially. Nothing on this Site constitutes an offer to sell or a solicitation to buy any securities or products. 

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INDICATIONS AND USAGE

LICART contains diclofenac epolamine, which is a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
  • LICART is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

CONTRAINDICATIONS

LICART is contraindicated in the following patients:

  • Known hypersensitivity to diclofenac or any components of the drug product.
  • History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
  • In the setting of CABG surgery.
  • For use on non-intact or damaged skin.

WARNINGS AND PRECAUTIONS

  • Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
  • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
  • Heart Failure and Edema: Avoid use of LICART in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
  • Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of LICART in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
  • Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
  • Exacerbation of Asthma Related to Aspirin Sensitivity: LICART is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
  • Serious Skin Reactions: Discontinue LICART at first appearance of skin rash or other signs of hypersensitivity.
  • Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically.
  • Fetal Toxicity: Limit use of NSAIDs, including LICART, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks' gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
  • Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

ADVERSE REACTIONS

Most common adverse reactions for LICART are application site pruritus and other application site reactions.
To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at: 1-800-587-3513 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.
For Full Prescribing Information, visit licart.com/wp-content/uploads/2023/10/Licart-Full-Prescribing-Information_2024.pdf.

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