{"active_ingredient":["Active Ingredient Benzocaine 20%"],"do_not_use":["Do not use • for teething • in children under 2 years of age • more than recommended • for more than 7 days unless told to do so by a dentist or doctor"],"dosage_and_administration":["Directions • do not exceed recommended dosage • do not use for more than 7 days unless told to do so by a dentist or doctor • adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist • children between 2 and 12 years of age: adult supervision should be given in use of this product • children under 2 years of age: do not use"],"effective_time":"20231031","id":"0904e5d4-6c9c-156d-e063-6294a90a4a7d","inactive_ingredient":["Inactive ingredients Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic Acid"],"indications_and_usage":["Uses temporary relieves pain associated with the following mouth and gum irritations: • toothache • sore gums • canker sores • braces • minor dental procedures • dentures"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["Oral Pain Relief"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["GERI-CARE PHARMACEUTICAL CORP"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["57896-139-05"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["57896-139"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["238910"],"spl_id":["0904e5d4-6c9c-156d-e063-6294a90a4a7d"],"spl_set_id":["d294a39e-55f4-272d-e053-2995a90ab7f7"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"],"upc":["0357896139056"]},"package_label_principal_display_panel":["1"],"purpose":["Purpose Oral anesthetic"],"questions":["Questions or Comments? 1-800-540-3765"],"set_id":"d294a39e-55f4-272d-e053-2995a90ab7f7","spl_product_data_elements":["Oral Pain Relief BENZOCAINE POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 1500 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM SORBIC ACID BENZOCAINE BENZOCAINE"],"spl_unclassified_section":["Drug Facts","Other information • do not use tube if it is cut prior to opening • to open tube, cut open tip of tube on score mark with scissors • store at a controlled room temperature 68º-77ºF (20º-25ºC)"],"stop_use":["Stop use and ask a doctor if • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash or fever develops"],"version":"2","warnings":["Warnings METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics. If a skin reaction occurs, stop use and seek medical help right away. Do not use • for teething • in children under 2 years of age • more than recommended • for more than 7 days unless told to do so by a dentist or doctor When using this product • avoid contact with the eyes Stop use and ask a doctor if • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash or fever develops Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product • avoid contact with the eyes"]}