Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Salicor™ is available as the following: 1 carton, 15 systems NDC 83881-501-15; carton front carton back
- HOW SUPPLIED Salicor™ is available as the following: 1 carton, 15 systems NDC 83881-501-15
- carton front carton back
Overview
Salicor™ is an external analgesic product containing 10% triethanolamine salicylate as the active ingredient. Triethanolamine salicylate is an organic compound formed between triethanolamine and salicylic acid, where triethanolamine neutralizes the acidity of salicylic acid. This external analgesic is designed for temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises. Unlike other external analgesics, triethanolamine salicylate has no distinct odor, which improves patient acceptability.
Indications & Usage
INDICATION AND USAGE 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.
Dosage & Administration
For adults 18 years and older: • Clean and dry the affected area • Locate the tear notch on the edge of the pouch. Tear open at the notch or carefully cut open the pouch with scissors, taking care not to cut the system inside • Remove the transparent release liner before applying Salicor™ to the skin • Apply one Salicor™ to the affected area of pain and leave it in place for 8 to 12 hours • Apply only one Salicor™ at a time • If pain persists, the used Salicor™ may be replaced with a new one for up to 8 to 12 more hours • Always remove and properly dispose of the used Salicor™ before applying a new one • Salicor™ may be cut into smaller sizes with scissors prior to removing the release liner • Safely discard the used Salicor™ (whole or cut pieces) where children and pets cannot access it • Wash hands with soap and water after applying or removing Salicor™ Visual Guide provided below: These highlights do not include all the information needed to use Salicor™ safely and effectively. See full prescribing information for Salicor™ dosing
Warnings & Precautions
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.
Drug Interactions
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
Storage & Handling
STORAGE AND HANDLING Avoid contact with the eyes. Keep away from excessive heat and direct sunlight. Salicor™ should be kept out of reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
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