{"active_ingredient":["Active Ingredients & Purposes Active Ingredient Purpose Benzocaine 10%........................................................ Oral pain reliever"],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active Ingredient</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Benzocaine 10%........................................................</td><td>Oral pain reliever</td></tr></tbody></table>"],"ask_doctor_or_pharmacist":["Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days symptoms clear up and occur again within a few days irritation, pain or redness persists or worsens swelling, rash, or fever develops"],"do_not_use":["Do not use for teething in children under 2 years of age"],"dosage_and_administration":["Directions apply product with cotton swab or clean fingertip to the affected area adults and children 2 years of age and older : use up times 4 times daily or as directed by a dentist or doctor. Children should be supervised in the use of this product. children under 2 years of age : do not use"],"effective_time":"20241115","id":"26f71ff3-08b2-6177-e063-6394a90ace74","inactive_ingredient":["Inactive ingredients benzalkonium chloride, peppermint oil, polyethylene glycol 400, propylene glycol, sodium saccharin, tannic acid"],"indications_and_usage":["Uses Temporarily relieves pain due to canker sores cold sores fever blisters minor irritations or injury of the mouth and gums"],"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":["TANAC Oral Pain Reliever"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Leosons Overseas Corp"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["69626-0049-4"],"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":["69626-0049"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["583152","1053339"],"spl_id":["26f71ff3-08b2-6177-e063-6394a90ace74"],"spl_set_id":["81cc61fa-31a7-2214-e053-2a91aa0ae46a"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"other_safety_information":["Other information store at 20 - 25°C (68 - 77°F) do not use if imprinted safety seal is torn, broken or missing prior to opening keep carton for full drug facts"],"package_label_principal_display_panel":["Principal Display Panel canker sores gum irritations cold sores fever blisters Tanac ® Benzocaine 10% Oral Pain Reliever NO STING LIQUID 0.45 FL Oz. (13.3mL) Tanac Box"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active Ingredient Purpose Benzocaine 10%........................................................ Oral pain reliever"],"purpose_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active Ingredient</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Benzocaine 10%........................................................</td><td>Oral pain reliever</td></tr></tbody></table>"],"questions":["Questions? 1-855-452-9500 or email at info@leosonsintl.com"],"set_id":"81cc61fa-31a7-2214-e053-2a91aa0ae46a","spl_product_data_elements":["TANAC Oral Pain Reliever Benzocaine SACCHARIN SODIUM SACCHARIN TANNIC ACID PEPPERMINT OIL PEPPERMINT PROPYLENE GLYCOL BENZALKONIUM CHLORIDE POLYETHYLENE GLYCOL 400 BENZOCAINE BENZOCAINE"],"spl_unclassified_section":["Drug Facts"],"version":"4","warnings":["Warnings For oral use only. 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. Flammability warning: Keep away from fire or flame. Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days symptoms clear up and occur again within a few days irritation, pain or redness persists or worsens swelling, rash, or fever develops If pregnant or breast-feeding, ask a health professional before use. Do not use for teething in children under 2 years of age When using this product avoid contact with the eyes do not use more than directed do not use for more than 7 days unless directed by a dentist or doctor Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.","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.","Flammability warning: Keep away from fire or flame."],"when_using":["When using this product avoid contact with the eyes do not use more than directed do not use for more than 7 days unless directed by a dentist or doctor"]}