{"active_ingredient":["Active Ingredient - Benzocaine, 20% Benzocaine 20% w/v"],"ask_doctor":["Consult a doctor promptly If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. If mouth sore does not go away within 10 days. If irritation, pain, or redness persists or worsens."],"do_not_use":["Do not use Do not use if you have a history of allergy to any \"caine\" local anesthetics or FD&C Red #40. Do not use for teething or in children under 2 years of age."],"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 daily or as directed by a dentist or doctor. • Do not exceed recommended dosage. • This product is for adults and children 2 years of age and older. • Children under 2 years of age should consult a dentist or a doctor."],"effective_time":"20260501","id":"50cb6dbf-74de-4f3a-e063-6394a90a21bb","inactive_ingredient":["Inactive ingredients Polyethylene glycol 400, propylene glycol 3350, saccharin, flavor, FD&C Red #40."],"indications_and_usage":["Indications and usage section For anesthesia of mucous membrane of oropharynx. Temporarily relieves pain or discomfort caused by minor dental procedures, orthodontic appliances, teething, canker sores, cold sores, fever blisters, minor injury of the mouth or gums, and 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 Strawberry"],"generic_name":["GINGICAINE GEL STRAWBERRY FLAVOR"],"is_original_packager":[true],"manufacturer_name":["Gingi-Pak a Division of the Belport"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10129-036-01","10129-036-04","10129-036-05"],"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":["10129-036"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL","ORAL","PERIODONTAL"],"rxcui":["238910","543801"],"spl_id":["50cb6dbf-74de-4f3a-e063-6394a90a21bb"],"spl_set_id":["2fd37612-a28b-3aa1-e054-00144ff8d46c"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Strawberry Label USA Jar Label","GingiCaine Gel Syringe label Syringe Label","GingiCAINE in Syringe Box Syringe Box"],"purpose":["Purpose Oral Anesthetic"],"recent_major_changes":[""],"set_id":"2fd37612-a28b-3aa1-e054-00144ff8d46c","spl_product_data_elements":["Gingicaine Gel Strawberry Gingicaine Gel Strawberry Flavor POTASSIUM SODIUM SACCHARATE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 Strawberry Flavor"],"storage_and_handling":["Avoid excessive heat DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN. Storage information: Avoid excessive heat above 40°C (104°F)."],"version":"13","warnings":["Precaution Section Dentists should avoid application to severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes. Local anesthetics should be used with caution in patients with known drug sensitivities, particularly those known to be allergic to ester-type anesthetics (procaine, benzocaine, tetracaine). Dentists should avoid contact with all local anesthetics to avoid possible sensitization.","Warnings 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 Do not use in children under 2 years of age."]}