{"active_ingredient":["Active ingredient and Purpose . Active ingredient Purpose Benzocaine 20%...................... 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 20%......................</td><td>Oral pain reliever</td></tr></tbody></table>"],"ask_doctor":["Stop use and ask your 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"],"do_not_use":["Do not use more than directed for more than 7 days unless directed by a dentist or doctor for teething in children under 2 years of age"],"dosage_and_administration":["Directions adults and children 2 years of age and older: apply product to a cotton swab or finger to the affected area. Allow to remain in place at least 1 minute and then spit out. 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 the product children under 2 years of age: do not use"],"effective_time":"20260526","id":"52bc0c9b-e399-5c55-e063-6294a90aa2f2","inactive_ingredient":["Inactive ingredients alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium saccharin, sodium methylparaben"],"indications_and_usage":["Uses For the temporary relief of canker sores minor injury of the mouth and gums minor irritation of the mouth and gums caused by dentures or orthodontic appliances"],"keep_out_of_reach_of_children":["Keep out of reach of children. If more than used for pain is accidentally swallowed or an allergic reaction occurs, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["Dolodent Maximum Strength"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["55758-505-01"],"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":["55758-505"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1435490"],"spl_id":["52bc0c9b-e399-5c55-e063-6294a90aa2f2"],"spl_set_id":["351ecc2b-cc1a-2bbf-e063-6394a90a5c14"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"other_safety_information":["Other information do not use if clear seal over cap is torn, broken, or missing store between 68-77°F (20-25°C)"],"package_label_principal_display_panel":["Principal Display Panel PDP DOLODENT"],"purpose":["Active ingredient Purpose Benzocaine 20%...................... 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 20%......................</td><td>Oral pain reliever</td></tr></tbody></table>"],"questions":["Questions or comments? +1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com"],"set_id":"351ecc2b-cc1a-2bbf-e063-6394a90a5c14","spl_product_data_elements":["Dolodent Maximum Strength Benzocaine ALCOHOL CLOVE OIL GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM SACCHARIN SODIUM METHYLPARABEN BENZOCAINE BENZOCAINE PROPYLENE GLYCOL"],"spl_unclassified_section":["DRUG FACTS","Dist. by/ por: Dist. by/ por: PHARMADEL LLC New Castle, DE 19720 +1-866-359-3478 www.pharmadel.com"],"version":"4","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. Flammable . Keep away from fire or flame. Avoid smoking during application. Do not use more than directed for more than 7 days unless directed by a dentist or doctor for teething in children under 2 years of age Stop use and ask your 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 more than used for pain is accidentally swallowed or an allergic reaction occurs, get medical help or contact a Poison Control Center right away."]}