{"active_ingredient":["Active Ingredient Menthol 5%"],"dosage_and_administration":["DIRECTIONS Adults and Children 12 years of age and older: • Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch • Should be used up to 8 hours • Should be used no more than 3 to 4 times daily Children under 12 years of age: Consult a doctor."],"effective_time":"20250929","id":"6e490a04-d32f-4dec-9ced-ab55fae6efb1","inactive_ingredient":["Inactive Ingredients Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water"],"indications_and_usage":["Uses Temporarily relieve minor aches and pains of muscles and joints due to • simple backache • arthritis • muscle strains • bursitis • tendonitis • muscle sprains • bruises • cramps"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."],"openfda":{"application_number":["M017"],"brand_name":["COLD AND HOT MEDICATED LARGE"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Universal Distribution Center LLC"],"package_ndc":["52000-421-41","52000-421-42"],"product_ndc":["52000-421"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["420222"],"spl_id":["6e490a04-d32f-4dec-9ced-ab55fae6efb1"],"spl_set_id":["d6780230-aa96-4055-b054-be41358568b6"],"substance_name":["MENTHOL, UNSPECIFIED FORM"],"unii":["L7T10EIP3A"]},"package_label_principal_display_panel":["Packaging COLD AND HOT MEDICATED LARGE"],"purpose":["Purpose Topical Analgesic"],"set_id":"d6780230-aa96-4055-b054-be41358568b6","spl_product_data_elements":["COLD AND HOT MEDICATED LARGE Menthol MENTHOL, UNSPECIFIED FORM MENTHOL DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS EDETATE DISODIUM ETHYLHEXYLGLYCERIN GLYCERIN PHENOXYETHANOL POVIDONE, UNSPECIFIED CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER"],"spl_unclassified_section":["Drug Facts","*Compare to the active ingredient in Icy Hot ® Patch EXTRA STRENGTH Contains Menthol 5% Pain relieving ointment on a breathable adhesive pad EXTRA STRENGTH COLD & HOT MEDICATED PATCH works on contact providing pain relief that lasts for hours. The thin, flexible patch is comfortable to wear and is easy to remove. FAST RELIEF OF MINOR ACHES AND PAINS *This product is NOT manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot ® Patch. Distributed By: Universal Distribution Center 96 Distribution Boulevard • Edison, NJ 08817 MADE IN CHINA www.universaldc.com"],"storage_and_handling":["Other Information • store at room temperature 68° to 77°F (20° to 25°C)"],"version":"7","warnings":["WARNINGS: EXTERNAL USE ONLY When using this product • USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin. STOP USE and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops If pregnant or breast-feeding , ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."]}