Triethanolamine Salicylate

Salicor™ is indicated for the temporary relief of minor aches and pains of muscles and joints associated with: arthritis, simple backache, muscle strains and sprains, bruises, bursitis, and dysmenorrhea. Salicor™ provides a localized analgesic effect directly at the site of pain, offering convenience and sustained relief compared to cream formulations.

PRECAUTIONS General If irritation or a burning sensation occurs during application, wash the product off your skin and do not reapply until the irritation subsides. When Salicor™ is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Stop use and ask a doctor if

• Condition worsens
• Symptoms persist for more than 7 days, or symptoms return within a few days after discontinuing use
• Redness is present
• Irritation develops Hepatic Disease Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of triethanolamine salicylate because of their inability to metabolize triethanolamine salicylate normally. Allergic Reactions Although rare, allergic reactions to oral or external triethanolamine salicylate may occur. Seek emergency medical help if you experience hives, difficulty breathing, or swelling of the face, lips, tongue, or throat, as these may indicate a serious allergic reaction. Non-intact Skin Although not tested, application to broken or inflamed skin may result in higher blood concentrations of triethanolamine salicylate from increased absorption. Salicor™ is only recommended for use on intact skin. External Heat Sources Placement of external heat sources, such as heating pads or electric blankets, over Salicor™ is not recommended, as this has not been evaluated and may increase plasma triethanolamine salicylate levels. Eye Exposure Although not studied, contact of Salicor™ with the eyes should be avoided based on the findings of severe eye irritation with the use of similar animal products. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. Information for Patients Methemoglobinemia Inform patients that the use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experiences the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Drugs That May Cause Methemoglobinemia When Used with Salicor™ Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia Class: Nitrates/Nitrites: Local anesthetics: Antineoplastic agents: Antibiotics: Antimalarials: Anticonvulsants: Other drugs: Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides chloroquine, primaquine phenobarbital, phenytoin, sodium valproate acetaminophen, metoclopramide, quinine, sulfasalazine carcinogenesis, mutagenesis

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy. Pregnancy Category B. Salicor™ has not been studied in pregnancy.

Safety and effectiveness in pediatric patients have not been established.