{"active_ingredient":["ACTIVE INGREDIENT Benzocaine 20% Menthol 0.26%"],"do_not_use":["Do not use ■ more than directed ■ for more than 7 days unless directed by a dentist or doctor ■ for teething ■ in children under 2 years of age"],"dosage_and_administration":["DIRECTIONS cut open tip of tube on score mark Adults and children 2 years of age and over: apply to affected area up to 4 times daily or as directed by a dentist or doctor Children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product. Children under 2 years of age: do not use"],"effective_time":"20241105","id":"262be295-4eb0-3136-e063-6294a90a7dcc","inactive_ingredient":["Inactive ingredients ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid"],"indications_and_usage":["USE for the temporary relief of pain due to toothaches"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away"],"openfda":{"application_number":["M022"],"brand_name":["Orajel 2X Medicated Gel"],"generic_name":["ORAL PAIN RELIEVER"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10237-782-25"],"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":["10237-782"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2117337"],"spl_id":["262be295-4eb0-3136-e063-6294a90a7dcc"],"spl_set_id":["262be295-4eaf-3136-e063-6294a90a7dcc"],"substance_name":["BENZOCAINE","MENTHOL"],"unii":["U3RSY48JW5","L7T10EIP3A"],"upc":["0310310430283"]},"other_safety_information":["Other information ■ do not use if tube tip is cut prior to opening ■ this preparation is intended for use in cases of toothache, only as temporary expedient until a physician can be consulted"],"package_label_principal_display_panel":["#1 ORAL PAIN RELIEF BRAND FOR ADULTS ORAJEL TM 2X TOOTHACHE & GUM MEDICATED IMMEDIATE PAIN RELIEF ORAL PAIN RELIEVER Soothes Irritated Gums Delivers Targeted Pain Relief GEL NET WT 0.25 OZ (7.0 g) Product Image"],"purpose":["PURPOSE Oral pain reliever"],"questions":["Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com"],"set_id":"262be295-4eaf-3136-e063-6294a90a7dcc","spl_product_data_elements":["Orajel 2X Medicated Gel Oral Pain Reliever POLYETHYLENE GLYCOL 400 AMMONIUM GLYCYRRHIZATE SODIUM SACCHARIN BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 MENTHOL MENTHOL SORBIC ACID"],"stop_use":["Stop use and ask a doctor if ■ symptoms do not improve in 7 days ■ swelling, rash or fever develops ■ irrnation, pain or redness persists or worsens"],"version":"1","warnings":["WARNINGS Methemogloblnemla 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","Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacalne, benzocaine or other \"caine\" anesthetics"]}