{"active_ingredient":["Active ingredient Benzocaine 20%"],"dosage_and_administration":["Directions Directions: Do not exceed recommended dosage. adults and children 2 years of age and older: apply 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":"20231108","id":"09a6bf06-ea77-5aee-e063-6294a90a3bb2","inactive_ingredient":["Inactive ingredients flavor, polyethylene glycol, sodium saccharin"],"indications_and_usage":["Uses for the temporary relief of occasional minor irritation and pain, associated with: canker sores sore mouth and throat minor injury of the mouth and gums minor dental procedures 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, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M022"],"brand_name":["HurriCaine Topical Anesthetic"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Beutlich Pharmaceuticals, LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["0283-0920-43","0283-0920-34"],"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":["0283-0920"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL","ORAL","PERIODONTAL"],"rxcui":["238910","996288"],"spl_id":["09a6bf06-ea77-5aee-e063-6294a90a3bb2"],"spl_set_id":["0d2c8c0c-4c72-4400-b3b5-ed578fa35167"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Principal Display Panel Gel Syringe Unit: 0283-1820-43 1.5g in 1 syringe Gel Syringe Pack of 4: 0283-1820-34 4 x 1.5g in 1 box. 4ct Syringe Box - Mint flavor Syringe Label - Mint flavor"],"purpose":["Purpose Oral Anesthetic"],"questions":["Questions or comments? 1-800-238-8542 M-F: 8:00 a.m. - 4:30 p.m. ET"],"set_id":"0d2c8c0c-4c72-4400-b3b5-ed578fa35167","spl_product_data_elements":["HurriCaine Topical Anesthetic Benzocaine POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM BENZOCAINE BENZOCAINE"],"stop_use":["Do not use Do not use: if the tray seal is broken or missing if cap is missing or damaged for teething in children under 2 years of age"],"storage_and_handling":["Other information store at 20°-25° C (68°-77° F)"],"version":"5","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 if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly."],"when_using":["When using this product avoid contact with eyes"]}