{"active_ingredient":["Active Ingredient Lidocaine HCL 4%"],"dosage_and_administration":["Direction Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a physician."],"effective_time":"20260603","id":"535f66da-cd79-3c26-e063-6294a90a0798","inactive_ingredient":["Inactive ingredients CYCLOMETHICONE Emu Oil Ethoxydiglycol Ethylhexylglycerin Glycerin Isopropyl Myristate Phenoxyethanol Polyacrylate Crosspolymer-6 Polysorbate 60 Water Xanthan Gum"],"indications_and_usage":["Uses For the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations"],"keep_out_of_reach_of_children":["Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["PURE PRIMAL DELAY"],"generic_name":["LIDOCAINE HCL"],"is_original_packager":[true],"manufacturer_name":["Prodigy Media Inc"],"package_ndc":["70171-0060-1"],"product_ndc":["70171-0060"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["535f66da-cd79-3c26-e063-6294a90a0798"],"spl_set_id":["1ddab664-7c44-452f-854f-e386cd69505e"],"substance_name":["LIDOCAINE HYDROCHLORIDE"],"unii":["V13007Z41A"]},"package_label_principal_display_panel":["Product label PPM Delay Label PPM Delay Box"],"purpose":["Purpose External Analgesic"],"set_id":"1ddab664-7c44-452f-854f-e386cd69505e","spl_product_data_elements":["PURE PRIMAL DELAY Lidocaine HCL WATER CYCLOMETHICONE ETHOXYDIGLYCOL GLYCERIN EMU OIL ISOPROPYL MYRISTATE ETHYLHEXYLGLYCERIN PHENOXYETHANOL POLYACRYLATE CROSSPOLYMER-6 XANTHAN GUM POLYSORBATE 60 LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE"],"spl_unclassified_section":["Other information Do not use if seal is broken.","Questions? 866-488-0066"],"version":"5","warnings":["Warnings For external use only. Avoid contact with eyes Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days Symptoms clear up and occur again within a few days Do not use in large quantities, particularly over raw surfaces or blistered areas. Do not exceed the recommended daily dosage unless directed by a doctor. Do not use On wounds or damaged skin."]}