{"active_ingredient":["Active ingredient Benzocaine 20.0% (w/w)"],"dosage_and_administration":["Directions Adults and children 2 years of age and older: apply to affected area using applicator tip 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: consult a dentist or doctor"],"effective_time":"20250812","id":"3c30a984-220e-ed07-e063-6394a90ae4d7","inactive_ingredient":["Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water"],"indications_and_usage":["Uses Temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures"],"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":["M022"],"brand_name":["Topcare Maximum Strength"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["36800-443-58"],"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":["36800-443"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308657"],"spl_id":["3c30a984-220e-ed07-e063-6394a90ae4d7"],"spl_set_id":["6586fcda-b232-46b4-8461-c0042a4127c6"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Card R4"],"purpose":["Purpose Oral anesthetic"],"set_id":"6586fcda-b232-46b4-8461-c0042a4127c6","spl_product_data_elements":["Topcare Maximum Strength Benzocaine POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM PROPYLENE GLYCOL METHYLPARABEN BENZYL ALCOHOL WATER FD&C RED NO. 40 D&C YELLOW NO. 10 FD&C BLUE NO. 1 BENZOCAINE BENZOCAINE N&A Mint Flavor 619179 dark orange/red to sl brown"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 QUESTIONS? 1-888-423-0139 topcare@topco.com MADE IN CANADA"],"stop_use":["Stop use and ask doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops"],"storage_and_handling":["Other information do not use if package has been opened store at 20 - 25°C (68-77°F)"],"version":"14","warnings":["Warnings 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 When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a dentist or doctor Stop use and ask doctor or dentist 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. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a dentist or doctor"]}