{"active_ingredient":["Active ingredient Benzocaine 20%"],"do_not_use":["Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor for teething in children under 2 years of age"],"dosage_and_administration":["Directions cut open tip of tube on scoremark adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product. children under 2 years of age: do not use"],"effective_time":"20251113","id":"437fcc59-02bc-7d8c-e063-6394a90af1c0","inactive_ingredient":["Inactive ingredients flavor, polyethylene glycol, sodium saccharin, sorbic acid"],"indications_and_usage":["Use for the temporary relief of pain due to toothaches"],"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":["TopCare Oral Pain Relief Maximum Strength"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["36800-512-29"],"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":["36800-512"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["238910"],"spl_id":["437fcc59-02bc-7d8c-e063-6394a90af1c0"],"spl_set_id":["835fb6ac-dbb7-5566-e053-2991aa0af5e2"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"other_safety_information":["Other information do not use if tip is cut prior to opening this preparation is intended for use in cases of toothache, only as a tempory expedient until a dentist can be consulted do not use continuously"],"package_label_principal_display_panel":["Carton R4"],"purpose":["Purpose Oral Pain Reliever"],"set_id":"835fb6ac-dbb7-5566-e053-2991aa0af5e2","spl_product_data_elements":["TopCare Oral Pain Relief Maximum Strength Benzocaine POLYETHYLENE GLYCOL, UNSPECIFIED SACCHARIN SODIUM SACCHARIN BENZOCAINE BENZOCAINE SORBIC ACID"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60057 QUESTIONS\" 1-888-423-0139 topcare@topco.com www.topcarebrand.com"],"stop_use":["Stop use and ask a doctor if swelling, rash, fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days allergic reaction occurs"],"version":"14","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 Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor for teething in children under 2 years of age Stop use and ask a doctor if swelling, rash, fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days allergic reaction occurs Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}