Triethanolamine Salicylate

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.