{"active_ingredient":["Active ingredient Benzocaine 20% w/v"],"ask_doctor":["Stop use and ask a doctor if Ask a doctor before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obstruct protective reflexes."],"do_not_use":["Allergy Alert and Contraindication Do not use if you have a history of allergy to any “Caine” local anesthetics. Avoid contact with eyes. Keep out of reach of children. If more than normal usage amount is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage."],"dosage_and_administration":["Dosage and Administration Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anesthetic. Sterile cotton or gauze should be used in applying anesthetic to mucosa. Care must be taken to avoid cross–contamination between patients. Total dose should not exceed the amount required for anesthesia. Apply to the affected area. Remain in place for at least 1 minute and then spit out. • Use up to 4 times a day or as directed by a dentist or doctor. • This product is for adults and children 2 years of age and older."],"effective_time":"20260625","id":"551e4115-9355-7ef8-e063-6394a90a5bd5","inactive_ingredient":["Inactive ingredient polyethylene glycol 400, polyethylene glycol 3350, sodium saccharin, flavor, D&C Yellow #10"],"indications_and_usage":["Indications and Uses For anesthesia of mucous membrane of oropharynx. Temporary relief of pain or discomfort caused by • Minor dental procedures • Minor gum injury • canker sores • Sore throat • Minor mouth or gum irritations caused by dentures or orthodontic appliances"],"keep_out_of_reach_of_children":["Keep out of reach of children Keep out of reach of children. If more than normal usage amount is accidentally swallowed, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M022"],"brand_name":["GingiCaine Gel"],"generic_name":["GINGICAINE GEL BANANA FLAVOR"],"is_original_packager":[true],"manufacturer_name":["Gingi-Pak a Division of the Belport"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10129-035-03","10129-035-05","10129-035-01"],"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":["10129-035"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL","ORAL","PERIODONTAL"],"rxcui":["238910","543801"],"spl_id":["551e4115-9355-7ef8-e063-6394a90a5bd5"],"spl_set_id":["62857d06-a829-4efa-e053-2991aa0a6d15"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["GingiCaine Gel Banana label Manufactured by: Gingi-Pak®, 4825 Camarillo, CA 93012 www.gingi-pak.com Gingicaine® Banana Topical Anesthetic Gel 20% Benzocaine Oral Anesthetic REF 20113 NDC 10129-035-03 1 oz. Jar Label","Gingicaine Gel Banana-Hakusui Jar Label-JP"],"purpose":["Purpose Oral Anesthetic"],"recent_major_changes":[""],"set_id":"62857d06-a829-4efa-e053-2991aa0a6d15","spl_product_data_elements":["GingiCaine Gel GingiCaine Gel Banana flavor BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM SODIUM SACCHARATE"],"storage_and_handling":["Avoid excessive heat DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN. Avoid excessive heat above 40°C (104°F)."],"version":"4","warnings":["Warnings Do not use if you have a history of hypersensitivity to ester–type local anesthetics, not for use with teething or children under 2 years of age. For topical use only Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Consumers are advised to cease use and seek immediate medical attention if they or a child in their care develop: • Pale, gray, or blue colored skin (cyanosis) • Headache • Rapid heart rate • Shortness of breath • Dizziness or lightheadedness • Fatigue or lack of energy Sore throat is severe and more than 2 days Fever, headache, rash, nausea, or vomiting develops Mouth sores do not go away in 7 days Irritation, pain, or redness worsens"]}