{"active_ingredient":["Benzocaine 20%"],"ask_doctor":["Stop use and ask a doctor 1. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting 2. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens"],"dosage_and_administration":["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":"20241211","id":"28dd1dbf-cda2-de75-e063-6294a90a48f6","inactive_ingredient":["Benzalkonium Chloride (as a preservative), Carbomers, D&C Red Dye # 40, Flavorings, Polyethylene Glycol, Purified Water, Saccharin Sodium"],"indications_and_usage":["For the temporary relief of minor pain irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedure, minor irritation caused by dentures or orthodontic appliances"],"information_for_owners_or_caregivers":["Peel for Drug Facts NDC 10733-176-01 Premier Topicale Xtra Topical Anesthetic Gel Benzocaine, 20 % REF 9007154 Jammin' Strawberry 28.35g (1 o.z.) For Topical Use only - Not for Injection Contains: 20 % Benzocaine in a specially designed glycol base Made in U.S.A. premierdentalco.com Manufactured for: Premier® Dental Products Company, 1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A. Mfg: Medical Products Laboratories, Inc. 9990 Global Road Philadelphia, PA 19115 U.S.A. 1120049 MPL Rev5 . 2000267(00) 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 premierdentalco.com."],"keep_out_of_reach_of_children":["In case of accidental overdose, get medical help or contact a Poison Control Centre immediately. Do not use more than directed."],"openfda":{"application_number":["M022"],"brand_name":["Topicale Xtra"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Medical Products Laboratories,Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10733-176-01"],"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":["10733-176"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["238910","864735"],"spl_id":["28dd1dbf-cda2-de75-e063-6294a90a48f6"],"spl_set_id":["e3da0e63-a891-72bd-e053-2a95a90a58bc"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"other_safety_information":["Do not use if imprinted seal under cap is broken or missing Store at 68º to 77º F (20º - 25º C)"],"package_label_principal_display_panel":["Package Carton Package Label"],"purpose":["Oral Anesthetic"],"set_id":"e3da0e63-a891-72bd-e053-2a95a90a58bc","spl_product_data_elements":["Topicale Xtra Benzocaine BENZOCAINE BENZOCAINE WATER SACCHARIN SODIUM BENZALKONIUM CHLORIDE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) POLYETHYLENE GLYCOL 400 FD&C RED NO. 40"],"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 light headedness, 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. Do not use more than directed. Stop use and ask a doctor 1. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting 2. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens"]}