{"active_ingredient":["Active Ingredients Benzocaine 20% (w/w)"],"do_not_use":["Do not use for teething in children under 2 years of age"],"dosage_and_administration":["Directions adults and children 2 years of age and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor. children under 2 years of age: do not use"],"effective_time":"20240216","id":"11867852-2084-bc57-e063-6394a90a45da","inactive_ingredient":["Inactive ingredients PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid"],"indications_and_usage":["Uses temporarily relieves pain caused by toothache dental work minor irritation or injury of the mouth and gums canker sores gum sores cheek bites denture irritation"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["Pain Relief"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Safetec of America, Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["61010-8100-2","61010-8100-1"],"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":["61010-8100"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["248280"],"spl_id":["11867852-2084-bc57-e063-6394a90a45da"],"spl_set_id":["de84e598-d047-4fae-b2ed-155a3788bc6f"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"other_safety_information":["Other Information Do not use if packet is torn, cut, or opened Store at room temperature, 15º to 30ºC (59º to 86ºF) Avoid contact with eyes"],"package_label_principal_display_panel":["Principal Display Panel - Safetec Oral Pain Relief Carton Label NDC 61010-800-1 Safetec First Aid Oral Pain Relief Fast mouth sore relief for: Canker Sores Gum Pain Toothache Dental Work Reorder No. 53117 To reorder: Call: 1-800-456-7077 Fax: 716-895-2969 Online: www.safetec.com Principal Display Panel - Safetec Oral Pain Relief Carton Label","Principal Display Panel - Safetec Oral Pain Relief Packet Label Safetec Oral Pain Relief 0.75 g (1/38 oz.) Safetec of America, Inc. Buffalo, NY 14215 800-456-7077 Principal Display Panel - Safetec Oral Pain Relief Packet Label"],"purpose":["Purpose Oral pain reliever"],"questions":["Questions or Comments? 1-800-456-7077"],"set_id":"de84e598-d047-4fae-b2ed-155a3788bc6f","spl_product_data_elements":["Pain Relief benzocaine POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 PEPPERMINT OIL SACCHARIN SODIUM SORBIC ACID BENZOCAINE BENZOCAINE"],"version":"4","warnings":["Warnings For oral use only. Avoid contact with eyes. 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 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. If a skin reaction occurs, stop use and seek medical help right away. Do not use for teething in children under 2 years of age When using this product Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage."]}