{"active_ingredient":["Active ingredient Benzocaine 20%"],"do_not_use":["Do not use for teething in children under 2 years of age"],"dosage_and_administration":["Directions to open tube, cut tip of the tube on score mark with scissors adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age adult supervision should be given in the use of this product children under 2 years of age do not use for denture irritation: apply thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting"],"dosage_and_administration_table":["
adults and children 2 years of age and overapply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist
children under 12 years of ageadult supervision should be given in the use of this product
children under 2 years of agedo not use
"],"effective_time":"20260622","id":"54dce1ca-e78b-aa07-e063-6294a90a93f9","inactive_ingredient":["Inactive ingredients benzyl alcohol, carbomer homopolymer type b, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin"],"indications_and_usage":["Uses temporarily 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. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["Anbesol Maximum Strength"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Foundation Consumer Brands"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["80070-220-33"],"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":["80070-220"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["238910","1052633"],"spl_id":["54dce1ca-e78b-aa07-e063-6294a90a93f9"],"spl_set_id":["dcc37403-0192-4658-bb7a-059273ce0047"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack MAXIMUM STRENGTH 20% Benzocaine Anbesol ® Oral Pain Reliever/Benzocaine 20% Instant Oral Pain Relief ADA Accepted American Dental Association Toothaches Canker Sores Aligner Pain Gum Pain GEL NET WT 0.33 OZ (9 g) PDP"],"purpose":["Purpose Oral pain reliever"],"questions":["Questions or comments? Call 1-888-594-0673 weekdays 9 AM to 5 PM EST"],"set_id":"dcc37403-0192-4658-bb7a-059273ce0047","spl_product_data_elements":["Anbesol Maximum Strength BENZOCAINE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED BENZYL ALCOHOL POLYSORBATE 80 PROPYLENE GLYCOL SACCHARIN BENZOCAINE BENZOCAINE"],"spl_unclassified_section":["Drug Facts","Distributed by: Foundation Consumer Brands, LLC Pittsburgh, PA 15212"],"stop_use":["Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness lasts or worsens swelling, rash, or fever develops"],"storage_and_handling":["Other information store at 20-25°C (68-77°F) do not refrigerate"],"version":"5","warnings":["Warnings METHEMOGLOBINEMIA WARNING Use of this product may cause methemoglobinemia, a rare but 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 for teething in children under 2 years of age When using this product avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness lasts or worsens swelling, rash, or fever develops Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist"]}