{"active_ingredient":["Active ingredient Benzocaine 5% Purpose Oral Pain Reliever"],"do_not_use":["Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other \"caine\" anesthetics."],"dosage_and_administration":["Directions Shake well upside down. Gargle, swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out. Children under 12 years of age should be supervised in the use of the product. Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Do not use for teething. Children under 2 years of age: Do not use."],"effective_time":"20250603","id":"36b1704e-640d-bab5-e063-6394a90a4145","inactive_ingredient":["Inactive ingredients: Purified water, Vegetable glycerin, PEG 400, Sorbitol, Polysorbate 80, Natural orange flavor, Potassium sorbate, Xanthan gum, Citric acid, Beta-carotene."],"indications_and_usage":["Uses For the temporary relief of minor irritation, pain, sore mouth, and sore throat."],"keep_out_of_reach_of_children":["Keep out of reach of children"],"openfda":{"application_number":["M022"],"brand_name":["Onral Oral Pain Reliever Mouthwash"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Syka Pharma Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["85454-0421-1"],"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":["85454-0421"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2717653"],"spl_id":["36b1704e-640d-bab5-e063-6394a90a4145"],"spl_set_id":["5dd8d933-6f32-4eaf-8eca-9365d7de55a2"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"],"upc":["0628942758683"]},"package_label_principal_display_panel":["Package Labeling: Label"],"purpose":["Purpose Oral Pain Reliever"],"set_id":"5dd8d933-6f32-4eaf-8eca-9365d7de55a2","spl_product_data_elements":["Onral Oral Pain Reliever Mouthwash BENZOCAINE WATER POLYETHYLENE GLYCOL 400 SORBITOL POLYSORBATE 80 POTASSIUM SORBATE XANTHAN GUM CITRIC ACID MONOHYDRATE BETA CAROTENE BENZOCAINE BENZOCAINE"],"spl_unclassified_section":["Drug Facts","Other information store at 68-77 ° F (20-25 ° C)"],"stop_use":["Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) rapid heart rate dizziness or lightheadedness headache shortness of breath atigue or lack of energy"],"version":"1","warnings":["Warnings 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 dentists or doctor promptly. Do not exceed recommended dosage. Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other \"caine\" anesthetics. Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce 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) rapid heart rate dizziness or lightheadedness headache shortness of breath atigue or lack of energy Keep out of reach of children"]}