{"active_ingredient":["Active Ingredient Benzocaine 18%"],"ask_doctor":["Stop use and ask a doctor : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens"],"dosage_and_administration":["Do not use more than directed. Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children 2-12 years of age - Should be supervised in the use of the product Children under 2 years of age - Do not use"],"effective_time":"20241216","id":"29694bac-976b-0291-e063-6394a90a32d1","inactive_ingredient":["Benzalkonium Chloride (as a preservative), Gelatin Hydrolysate, Glycerin, Flavorings,FD&C Blue Dye # 1, FD&C Yellow Dye # 5, Mineral Oil, Purified Water"],"indications_and_usage":["For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances"],"information_for_owners_or_caregivers":["NDC 10733-173-01 Premier Topicale GelPatch Oral Anesthetic Suspension Benzocaine, 18 % REF 9007149 Contains: 25 - 0.2gm Packets Mint Made in U.S.A. Manufactured for: Premier® Dental Products Company, 1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A. Manufacturer: Medical Products Laboratories, Inc. 9990 Global Road Philadelphia, PA 19115 U.S.A. 0818017 Rev2 MPL 317932 Questions or Comments? 888.670.6100 or 610.239.6000 M-Th: 7:30a.m. - 5:30p.m., F: 7:30a.m. - 4:00p.m. EST To obtain an SDS, contact Customer Service Department or visit www.premusa.com. Retain drug facts for future reference."],"keep_out_of_reach_of_children":["In case of accidental overdose, get medical help or contact a Poison Control Centre immediately."],"openfda":{"application_number":["M022"],"brand_name":["Topicale"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Medical Products Laboratories, Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10733-173-01"],"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":["10733-173"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["29694bac-976b-0291-e063-6394a90a32d1"],"spl_set_id":["8282a4a6-b77c-75fc-e053-2991aa0ad4ac"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"other_safety_information":["Store at 68º to 77º F (20º - 25º C)"],"package_label_principal_display_panel":["film carton"],"purpose":["Oral Anesthetic"],"set_id":"8282a4a6-b77c-75fc-e053-2991aa0ad4ac","spl_product_data_elements":["Topicale Benzocaine GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) FD&C YELLOW NO. 5 MINERAL OIL WATER GLYCERIN BENZOCAINE BENZOCAINE BENZALKONIUM CHLORIDE FD&C BLUE NO. 1"],"version":"4","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, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy. Contraindications: Do not use in large quantities or over large areas of body Do not use for Teething Do not use in children under 2 years of age Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other \"caine\" anesthetics. When using this product Avoid contact with eyes In case of accidental overdose, get medical help or contact a Poison Control Centre immediately. Stop use and ask a doctor : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens"]}