{"active_ingredient":["Active ingredient Pramoxine HCL 1%"],"do_not_use":["Do not use if you are allergic to any of the ingredients over large areas of the body"],"dosage_and_administration":["Directions adults and children 2 years of age and older: clean the affected area apply to affected area not more than 3 to 4 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor"],"effective_time":"20170309","id":"cbfe71fd-2d5c-4c98-8caf-68fe49e54b6f","inactive_ingredient":["Inactive ingredients butyrospermum parkii (shea butter), C18-22 hydroxyalkyl hydroxypropyl guar, calendula officinalis extract, cantharis vesicatoria extract, echinacea angustifolia extract, ethyl alcohol, hydrogenated polydecene, isopropyl myristate, lanolin, lanolin alcohol, petrolatum, phenoxyethanol, water, sodium hydroxide, sodium polyacryloyldimethyl taurate, trideceth-10"],"indications_and_usage":["Uses For the temporary relief of pain and itching associated with: minor burns insect bites sunburns minor cuts scrapes minor skin irritations"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["part348"],"brand_name":["First Degree Maximum Strength Burn"],"generic_name":["PRAMOXINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Welmedix LLC"],"package_ndc":["24330-130-02"],"product_ndc":["24330-130"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1052684"],"spl_id":["cbfe71fd-2d5c-4c98-8caf-68fe49e54b6f"],"spl_set_id":["1afa337e-f411-42df-b2f5-5f72c9b52ffa"],"substance_name":["PRAMOXINE HYDROCHLORIDE"],"unii":["88AYB867L5"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 21 g Tube Box NEW & IMPROVED! First° Degree ® MAXIMUM STRENGTH BURN CREAM PRAMOXINE HCL 1% PAIN RELIEVING CREAM FAST RELIEF FOR PAIN + ITCH GREAT FOR MINOR BURNS BUG BITES HELPS REDUCE THE APPEARANCE OF SCARS ENRICHED WITH NOURISHING BOTANICALS 1 Tube Net Wt 3/4 oz (21 g) Principal Display Panel - 21 g Tube Box"],"purpose":["Purpose External analgesic"],"questions":["Questions or Comments? 1-888-565-2876 Monday through Friday, 9am-5pm EST"],"set_id":"1afa337e-f411-42df-b2f5-5f72c9b52ffa","spl_product_data_elements":["First Degree Maximum Strength Burn Pramoxine Hydrochloride Pramoxine Hydrochloride Pramoxine SHEA BUTTER CALENDULA OFFICINALIS FLOWERING TOP LYTTA VESICATORIA GUAR GUM ECHINACEA ANGUSTIFOLIA ALCOHOL HYDROGENATED POLYDECENE (550 MW) ISOPROPYL MYRISTATE LANOLIN LANOLIN ALCOHOLS PETROLATUM PHENOXYETHANOL WATER SODIUM HYDROXIDE SODIUM TAURATE TRIDECETH-10"],"spl_unclassified_section":["Drug Facts","Distributed by: Welmedix Consumer Healthcare Princeton, NJ 08540"],"stop_use":["Stop use and ask a doctor if condition worsens symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops"],"storage_and_handling":["Other information store at 20-25°C (68-77°F)"],"version":"1","warnings":["Warnings For external use only. Avoid contact with the eyes Do not use if you are allergic to any of the ingredients over large areas of the body Stop use and ask a doctor if condition worsens symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}