{"active_ingredient":["Active Ingredient Lidocaine 3%"],"dosage_and_administration":["Directions adults and children 2 years and older apply to affected area not more than 3 to 4 times daily children under 2 years of age : ask a doctor"],"effective_time":"20250507","id":"3492e688-b7e8-d380-e063-6294a90a329f","inactive_ingredient":["Inactive Ingredients: Cyclopentasiloxane, Dihydroeugenol, Dimethicone, Dimethiconol, Dimethicone/Vinyl Dimethicone Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Isoeugenyl Acetate, Petrolatum, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane."],"indications_and_usage":["Uses Temporarily relieves pain and itching due to sunburn minor burns minor cuts 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":["M017"],"brand_name":["DermaRad Relief Post Radiation Calming"],"generic_name":["LIDOCAINE 3 PERCENT"],"is_original_packager":[true],"manufacturer_name":["Renu Laboratories, LLC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["76348-970-50","76348-970-01"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["76348-970"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2607527"],"spl_id":["3492e688-b7e8-d380-e063-6294a90a329f"],"spl_set_id":["e5d64929-fb9c-7ebc-e053-2995a90a9318"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"other_safety_information":["Manufactured in the U.S.A. for Dermamedics, LLC Oklahoma City, OK 73112 www.dermamedics.com 1 800 990 6552"],"package_label_principal_display_panel":["PRODUCT BOX FOR POST RADIATION CALMING SERUM PRODUCT ARTWORK product box PACKAGE ART"],"purpose":["Purpose External Analgesic"],"recent_major_changes":["No changes at all to section. We have cloned submission for a second product with another NDC Code. No changes to any section except Principal Package display and NDC #"],"set_id":"e5d64929-fb9c-7ebc-e053-2995a90a9318","spl_product_data_elements":["DermaRad Relief Post Radiation Calming Lidocaine 3 percent CYCLOMETHICONE 5 PETROLATUM JOJOBA OIL DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) ISOEUGENYL ACETATE SQUALANE LIDOCAINE LIDOCAINE DIHYDROEUGENOL SUNFLOWER OIL"],"statement_of_identity":["DERMAMEDICS Post Radiation Calming Serum with 3 % Lidocaine"],"stop_use":["Stop use and ask a doctor if Condition gets worse Symptoms persist for more than 7 days Symptoms clear up and occur again in a few days"],"version":"2","warnings":["Warnings For external use only"],"when_using":["When using this product Do not use in large quantities particularly over raw surfaces or blistered areas Avoid contact with the eyes"]}