{"active_ingredient":["Active ingredients Benzalkonium Chloride 0.13% Benzocaine 20% Menthol 0.26% Zinc Chloride 0.15%"],"do_not_use":["Do not use Do not use this product if you have a history of allergy to procaine, butacaine, benzocaine, or other \"caine\" class local anesthetics. Do not exceed the recommended dosage for more than 7 days unless directed by a dentist or doctor."],"dosage_and_administration":["Directions Adult 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 using this product. Children under 2 years of age - Do not use. Do not use if Amper-Evident Tab is open before first use. Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying."],"effective_time":"20260422","id":"fa8ae828-9f80-42f2-b23b-21d6c4bcb383","inactive_ingredient":["Inactive ingredients POLYETHYLENE GLYCOL 300, POLYETHYLENE GLYCOL 3000, SACCHARIN SODIUM, SORBIC ACID, CINNAMON, SALT SUBSTITUTE, SCHISANDRA CHINENSIS SEED, CYPERUS ROTUNDUS FRUIT"],"indications_and_usage":["Uses Temporarily relieves pain caused by minor oral and gum injuries. First aid to help prevent infection from minor oral irritations. Improves loose teeth and maintains dental health."],"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":["Ora YoGu 4X Medicated Tooth and Gum Pain Reliever"],"generic_name":["MEDICATED TOOTH AND GUM PAIN RELIEVER"],"is_original_packager":[true],"manufacturer_name":["Kungpo Health Care & Herbal Center Inc"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["87351-761-10"],"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":["87351-761"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["fa8ae828-9f80-42f2-b23b-21d6c4bcb383"],"spl_set_id":["1f10a72f-0b49-41cb-92f9-b0160d7664de"],"substance_name":["BENZOCAINE","BENZALKONIUM CHLORIDE","MENTHOL","ZINC CHLORIDE"],"unii":["U3RSY48JW5","F5UM2KM3W7","L7T10EIP3A","86Q357L16B"]},"other_safety_information":["Other information This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously. Do not use if Temper-Evident Tab is open before first use."],"package_label_principal_display_panel":["image description"],"purpose":["Purpose Benzalkonium Chloride Oral Antibacterial Benzocaine Oral Antibacterial Menthol Oral Antibacterial Zinc Chloride Oral Antibacterial"],"set_id":"1f10a72f-0b49-41cb-92f9-b0160d7664de","spl_product_data_elements":["Ora YoGu 4X Medicated Tooth and Gum Pain Reliever Medicated Tooth and Gum Pain Reliever BENZOCAINE BENZOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM MENTHOL MENTHOL ZINC CHLORIDE ZINC CATION POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 3000 SACCHARIN SODIUM SORBIC ACID CINNAMON SALT SUBSTITUTE SCHISANDRA CHINENSIS SEED CYPERUS ROTUNDUS FRUIT"],"spl_unclassified_section":["Drug Facts","Manufactured by Zhejiang Jingwei Pharmaceutical Co., Ltd Changshan Industrial Park, Zhejiang, China Product of China","Imported and distributed by KUNGPO HEALTH CARE & HERBAL CENTER INC. 1155 S. Milliken Ave, Suite H， Ontario, CA 91761 Phone: 909-377-6878"],"stop_use":["Stop use and ask a doctor if Stop use and seek immediate medical attention if you or 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 Sore mouth symptoms do not improve in 7 days. Swelling, rash or fever develops. Irritation, pain, or redness persists or worsens."],"version":"33048","warnings":["Warning Use of this product may cause methemoglobinemia, a serious condition that requires immediate treatment because it reduces the oxygen-carrying capacity of the blood. This can happen even if you have used this product before."]}