{"active_ingredient":["Active ingedient Benzocaine 20%"],"adverse_reactions":["Adverse Reactions: Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition."],"dosage_and_administration":["Directions do not exceed recommend 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: consult a dentist or doctor"],"effective_time":"20250108","id":"9ba522de-44db-9c46-e053-2a95a90a3e12","inactive_ingredient":["Inactive ingredient 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":["0283-0998-31"],"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":["0283-0998"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL","PERIODONTAL"],"rxcui":["238910","996288"],"spl_id":["9ba522de-44db-9c46-e053-2a95a90a3e12"],"spl_set_id":["723da3ae-3f1f-4962-920b-f2a30c8c3253"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"],"upc":["0072112002012"]},"package_label_principal_display_panel":["Principal Display Panel NDC 0283-0998-31 HURRICAINE® Topical Anesthetic GEL 20% Benzocaine Oral Anesthetic FRESH MINT Manufactured for: Beutlich® Pharmaceuticals, LLC Bunnell, FL www.beutlich.com image of 1oz carton"],"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":"723da3ae-3f1f-4962-920b-f2a30c8c3253","spl_product_data_elements":["HurriCaine Topical Anesthetic Benzocaine POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM BENZOCAINE BENZOCAINE"],"stop_use":["Stop use and ask doctor if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens"],"storage_and_handling":["Other information do not use if imprinted seal under cap is broken or missing store at 20-25 °C (68-77 °F)"],"version":"45","warnings":["Warnings Allergy alert: ​Do not use if you have a history of allergy to local anesthetics such as procaine, butaine, benzocaine or other \"caine\" anesthetics."],"when_using":["When using this product avoid contact with eyes"]}