{"active_ingredient":["Active Ingredient Menthol USP 4% Active"],"dosage_and_administration":["Directions Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a doctor."],"effective_time":"20260122","id":"48fdd7f5-f062-0f63-e063-6294a90a452a","inactive_ingredient":["Inactive Ingredients Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Certerii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leaf), Camphor, Carbomer, Glycerin, Llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, Tocopheryl Acetate, Triethanolamine"],"indications_and_usage":["Use(s) • Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains • Provides penetrating pain relief"],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed, get medical help. Contact a physician or Poison Control Center (1-800-222-1222) right way."],"openfda":{"application_number":["M017"],"brand_name":["X-Treme Freeze"],"generic_name":["COLD THERAPY GEL"],"is_original_packager":[true],"manufacturer_name":["Dynarex Corporation"],"package_ndc":["67777-144-11","67777-144-10","67777-144-21","67777-144-20","67777-144-41","67777-144-40","67777-144-71","67777-144-70"],"product_ndc":["67777-144"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["415974"],"spl_id":["48fdd7f5-f062-0f63-e063-6294a90a452a"],"spl_set_id":["79f0802f-03ad-bf8f-e053-2991aa0ae4b5"],"substance_name":["MENTHOL"],"unii":["L7T10EIP3A"],"upc":["0616784144412","0616784144214","0616784144122","0616784144719"]},"other_safety_information":["Questions? 1-888-DYNAREX Monday-Friday, 9AM-5PM EST"],"package_label_principal_display_panel":["1441 Label 1441_BX_MASTER","1442 Label 1442_IN_MASTER","1444 Label 1444_IN_MASTER","1447 Label 1447_IN MASTER"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding: Ask a health professional before use."],"purpose":["Purpose Cooling Pain Relief"],"set_id":"79f0802f-03ad-bf8f-e053-2991aa0ae4b5","spl_product_data_elements":["X-Treme Freeze Cold Therapy Gel ISOPROPYL MYRISTATE TROLAMINE MENTHOL MENTHOL CARBOXYPOLYMETHYLENE ALOE VERA LEAF GLYCERIN ISOPROPYL ALCOHOL ARNICA MONTANA FLOWER FRANKINCENSE CALENDULA OFFICINALIS FLOWER ILEX PARAGUARIENSIS LEAF MELISSA OFFICINALIS LEAF ARCTIUM LAPPA ROOT GREEN TEA LEAF ALPHA-TOCOPHEROL ACETATE SILICON DIOXIDE .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR FD&C YELLOW NO. 5 WATER FD&C BLUE NO. 1"],"stop_use":["Stop use and ask a doctor if: • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days, discontinue use of this product"],"storage_and_handling":["Other Information • Store in a cool dry place • Tamper evident. Do not use if seal is damaged."],"version":"6","warnings":["Warnings For External Use Only When using this product • Avoid contact with eyes • Do not apply to wounds or damaged skin • Do not bandage tightly Stop use and ask a doctor if: • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days, discontinue use of this product If pregnant or breast feeding: Ask a health professional before use. Keep out of reach of children If swallowed, get medical help. Contact a physician or Poison Control Center (1-800-222-1222) right way."],"when_using":["When using this product • Avoid contact with eyes • Do not apply to wounds or damaged skin • Do not bandage tightly"]}