{"active_ingredient":["Active Ingredient Benzocaine 20% Benzalkonium Chloride 0.1%"],"do_not_use":["Do not use ■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider"],"dosage_and_administration":["Directions ■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider ■ children under 12 years: should be supervised in the use of this product ■ children under 2 years of age: ask a physician or health care provider"],"effective_time":"20241219","id":"299dca27-d254-e6ea-e063-6394a90a4f74","inactive_ingredient":["Inactive ingredients ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid"],"indications_and_usage":["Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infectionin minor oral irritation"],"keep_out_of_reach_of_children":["Keep out of reach of children In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away"],"openfda":{"application_number":["M022"],"brand_name":["Oral Gel Oral Pain Relief"],"generic_name":["BENZOCAINE BENZALKONIUM CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Savvy Care and Cosmetics"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["83650-101-01"],"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":["83650-101"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1595155"],"spl_id":["299dca27-d254-e6ea-e063-6394a90a4f74"],"spl_set_id":["05ede7e4-5a0a-c942-e063-6294a90a8a24"],"substance_name":["BENZOCAINE","BENZALKONIUM CHLORIDE"],"unii":["U3RSY48JW5","F5UM2KM3W7"]},"package_label_principal_display_panel":["Package Label image description"],"purpose":["Purpose Oral pain reliever Antiseptic"],"set_id":"05ede7e4-5a0a-c942-e063-6294a90a8a24","spl_product_data_elements":["Oral Gel Oral Pain Relief Benzocaine Benzalkonium Chloride AMMONIUM GLYCYRRHIZATE POLYETHYLENE GLYCOL, UNSPECIFIED SACCHARIN SODIUM SORBIC ACID BENZOCAINE BENZOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM"],"spl_unclassified_section":["Other information ■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted ■ do not use continuously ■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening"],"stop_use":["Stop use and ask a physician if ■ swelling, rash or fever develops ■ irritation, pain or redness persists or worsens ■ symptoms do not improve in 7 days"],"version":"2","warnings":["Warnings ■ Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other \"caine\" anesthetics"]}