{"active_ingredient":["Active ingredients Tetracaine 2% Mineral oil 74.4% Purpose Topical analgesic Skin protectant"],"do_not_use":["Do not use on • deep or puncture wounds • animal bites • serious burns in large quantities, particularly over raw surfaces or blistered areas"],"dosage_and_administration":["Directions Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily Children under the age of 2 consult a doctor"],"effective_time":"20260115","id":"487041f0-3ef3-7c82-e063-6394a90aac74","inactive_ingredient":["Inactive ingredients peppermint oil, polyethylene, polyethylene oxide, polyethylene glycol, sodium carboxymethylcellulose"],"indications_and_usage":["Uses for the temporary relief of pain and itching associated with fever blisters and cold sores helps prevent and temporarily protects chapped or cracked lips helps prevent and protect from the drying effects of wind and cold weather"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center"],"openfda":{"application_number":["M017"],"brand_name":["Helocaine Cold Sore Fever Blister Treatment"],"generic_name":["TETRACAINE, MINERAL"],"is_original_packager":[true],"manufacturer_name":["Pagari Life Science Corp."],"nui":["N0000175683","M0007766","N0000175976"],"package_ndc":["83609-212-02"],"pharm_class_cs":["Esters [CS]"],"pharm_class_epc":["Ester Local Anesthetic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["83609-212"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2685213"],"spl_id":["487041f0-3ef3-7c82-e063-6394a90aac74"],"spl_set_id":["1b2eae09-5de0-9219-e063-6294a90af046"],"substance_name":["TETRACAINE","MINERAL OIL"],"unii":["0619F35CGV","T5L8T28FGP"]},"other_safety_information":["Other information store at 20º - 25º C (68º - 77º F)"],"package_label_principal_display_panel":["Package labeling label Label 2"],"purpose":["Purpose Topical analgesic Skin protectant"],"questions":["Questions or comments? call 1- (877) 513-3057 (toll-free)"],"set_id":"1b2eae09-5de0-9219-e063-6294a90af046","spl_product_data_elements":["Helocaine Cold Sore Fever Blister Treatment TETRACAINE, MINERAL HIGH DENSITY POLYETHYLENE TETRACAINE TETRACAINE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED MINERAL OIL MINERAL OIL PEPPERMINT OIL"],"spl_unclassified_section":["Drug Facts"],"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 allergic reaction (blister or rash worsens) to any of the ingredients"],"version":"2","warnings":["Warnings For external use only. Do not use on • deep or puncture wounds • animal bites • serious burns in large quantities, particularly over raw surfaces or blistered areas When using this product do not get into eyes 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 allergic reaction (blister or rash worsens) to any of the ingredients Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center"],"when_using":["When using this product do not get into eyes"]}