{"active_ingredient":["Active Ingredient Lidocaine HCI 2.0%"],"do_not_use":["Do Not Use In large quantities, particularly over raw or blistered areas Near eyes, if this happens rinse throughly with water"],"dosage_and_administration":["Directions Spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily. Not to be used on children under 12 years of age."],"effective_time":"20240712","id":"1d0cada6-0c76-81d5-e063-6394a90ad666","inactive_ingredient":["Inactive Ingredients Glycerin, hydroxypropyl methylcellulose, melaleuca alternifilia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol propylene glycol, triethanolamine, water"],"indications_and_usage":["Temporary pain relief associated with minor burns."],"keep_out_of_reach_of_children":["Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["Burn Relief"],"generic_name":["LIDOCAINE HCI 2.0%"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals USA, LLC."],"package_ndc":["69396-107-02"],"product_ndc":["69396-107"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1010769"],"spl_id":["1d0cada6-0c76-81d5-e063-6394a90ad666"],"spl_set_id":["e5e524cd-bb22-715f-e053-2995a90ab5d3"],"substance_name":["LIDOCAINE HYDROCHLORIDE"],"unii":["V13007Z41A"],"upc":["0850026393491"]},"package_label_principal_display_panel":["4049 GLOBE BURN SPRAY 2OZ REV09 071024 CDER"],"purpose":["Purpose Topical Pain Relief"],"questions":["Questions or Comments Call 1-888-296-9067"],"set_id":"e5e524cd-bb22-715f-e053-2995a90ab5d3","spl_product_data_elements":["Burn Relief Lidocaine HCI 2.0% WATER LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS GLYCERIN TEA TREE OIL PHENOXYETHANOL PROPYLENE GLYCOL OCTOXYNOL-9 POLYOXYL 40 HYDROGENATED CASTOR OIL SODIUM HYDROXIDE HYPROMELLOSES"],"spl_unclassified_section":["Distributed By: Trifecta Pharmaceuticals USA, LLC. 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com SKU: 4049"],"stop_use":["Stop use and ask a doctor If the condition worsens or persists for more than 7 days or clears up and returns."],"storage_and_handling":["Other information Store at controlled room temperature 68º-77ºF (20º-25ºC)"],"version":"4","warnings":["Warnings For External Use Only"]}