{"active_ingredient":["Active ingredients Benzocaine 20%"],"dosage_and_administration":["Directions • Adults and children 2 years of age and over: Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider • Children between 2 and 12 years of age: Should be supervised in the use of this product • Children under 2 years of age: Do not use"],"effective_time":"20260311","id":"4cc7d90b-e806-8b9e-e063-6394a90a886e","inactive_ingredient":["Inactive ingredients Ammonium Glycyrrhizate, Fragrance, Polyethylene Glycol 400, Polyethylene Glycol 4000, Saccharin Sodium, Sorbic Acid, Water"],"indications_and_usage":["Uses • for the temporary relief of pain due to toothaches • to help protect against infection in minor oral irritation"],"keep_out_of_reach_of_children":["Keep out of reach of children . in case of overdose or allergic reaction, get medical help"],"openfda":{"application_number":["M022"],"brand_name":["ORAL PAIN RELIEF"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Nantong Health & Beyond Hygienic Products Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["43473-100-04"],"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":["43473-100"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["238910"],"spl_id":["4cc7d90b-e806-8b9e-e063-6394a90a886e"],"spl_set_id":["a5f0be98-d47e-4307-8044-304a64db774b"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Packaging ORAL PAIN RELIEF"],"purpose":["Purposes Oral pain reliever"],"set_id":"a5f0be98-d47e-4307-8044-304a64db774b","spl_product_data_elements":["ORAL PAIN RELIEF Benzocaine AMMONIUM GLYCYRRHIZATE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 4000 SACCHARIN SODIUM SORBIC ACID WATER BENZOCAINE BENZOCAINE"],"spl_unclassified_section":["Drug facts","COOLING COMFORT FORMULA • FAST COOLING • TOOTH & GUM COMFORT ​ For Pain Relief & Toothaches Mfd for and Distributed by: Universal Distribution Center LLC 330 Applegarth Road, Monroe Township, NJ 08831 www.universaldc.com MADE IN CHINA"],"storage_and_handling":["Other information • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted • do not use continuosly • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying • do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening"],"version":"1","warnings":["Warnings 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 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 Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider Stop use and ask a physician if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days Keep out of reach of children . in case of overdose or allergic reaction, get medical help"]}