{"active_ingredient":["Active ingredient Benzocaine 20%"],"dosage_and_administration":["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: consult a dentist or doctor"],"effective_time":"20241028","id":"258ffae7-a428-8dae-e063-6294a90adcc0","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":["0283-0871-31"],"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":["0283-0871"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL","ORAL","PERIODONTAL"],"rxcui":["238910","996288"],"spl_id":["258ffae7-a428-8dae-e063-6294a90adcc0"],"spl_set_id":["1f3d68f6-afd6-42e7-b3e5-210228c8e7de"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Principal Display Panel NDC 0283-0871-31 HURRICAINE® Topical Anesthetic GEL 20% Benzocaine Oral Anesthetic ORIGINAL WILD CHERRY Manufactured for: Beutlich® Pharmaceuticals, LLC Bunnell, FL 32110 1 oz. Principal Display"],"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":"1f3d68f6-afd6-42e7-b3e5-210228c8e7de","spl_product_data_elements":["HurriCaine Topical Anesthetic Benzocaine POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM BENZOCAINE BENZOCAINE amber"],"stop_use":["Stop use and ask a doctor if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting if sore mouth symptoms do not improve in 7 days, or 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":"27","warnings":["Warnings Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics."],"when_using":["When using this product avoid contact with eyes"]}