{"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 Read Directions on side panel for how to use adults and children 2 years of age and older apply to the affected area, Gargle, swish around in the mouth, or allow to remain in place for at least 15 seconds 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"],"dosage_and_administration_table":["
adults and children 2 years of age and older apply to the affected area, Gargle, swish around in the mouth, or allow to remain in place for at least 15 seconds and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.
children under 12 years of ageshould be supervised in the use of the product
children under 2 years of agedo not use
"],"effective_time":"20260325","id":"83139f6d-1d4d-47d5-8da5-5dad5b9fe3b7","inactive_ingredient":["Inactive ingredients flavor, polyethylene glycol, sucralose"],"indications_and_usage":["Uses for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat."],"keep_out_of_reach_of_children":["Keep out of reach of children. If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."],"openfda":{"application_number":["M022"],"brand_name":["Benzocaine 20%"],"generic_name":["BENZOCAINE 20%"],"is_original_packager":[true],"manufacturer_name":["PAI Holdings, LLC dba PAI Pharma"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["0121-1077-01","0121-1077-25"],"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":["0121-1077"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["308657"],"spl_id":["83139f6d-1d4d-47d5-8da5-5dad5b9fe3b7"],"spl_set_id":["7fbce9a5-00dc-4a4a-8709-ab752bdf2f59"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Principal Display Panel - pouch NDC 0121- 1077 -01 BENZOCAINE 20% SOLUTION Individually Wrapped Single-Unit Dose Applicator 20% Benzocaine Oral Anesthetic CHERRY FLAVOR Store at 15° - 30°C (59 - 86°F) 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 the blood. This can occur even if you have used this product before. stop use and seek immediate medical attention if you or your 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. Please refer to Drug Facts for complete product information. 1 Single-Unit Dose Applicator 0.017 fl oz (0.5 mL) Benzocaine pouch","Principal Display Panel - carton NDC 0121- 1077 -25 PAI Pharma Compare to the active ingredient in HurriCaine ONE® BENZOCAINE 20% SOLUTION Individually Wrapped Single-Unit Dose Applicator 20% Benzocaine Oral Anesthetic CHERRY FLAVOR 25 Single-Unit Dose Applicators 0.017 fl. oz. (0.5 mL) EACH 0.425 fl. oz (12.5 mL) TOTAL Benzocaine carton"],"purpose":["Purpose Oral Anesthetic"],"questions":["Questions or comments? call 1-800-845-8210 *This product is not manufactured or distributed by Beutlich Pharmaceuticals. LLC, the distributor of HurriCaine ONE®, and owner of the registered trademark HurriCaine ONE®, [Beutlich Pharmaceuticals, LLC does not make or license PAI's product.]"],"set_id":"7fbce9a5-00dc-4a4a-8709-ab752bdf2f59","spl_product_data_elements":["Benzocaine 20% Benzocaine 20% BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 SUCRALOSE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop using and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops"],"storage_and_handling":["Other information do not use if foil pouch is torn or open store at 15-30°C (59-86°F)"],"version":"4","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 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 if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly. Do not use for teething in children under 2 years of age When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor or dentist Stop using and ask a doctor 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 accidently swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."],"when_using":["When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor or dentist"]}