{"active_ingredient":["Active Ingredient Benzocaine 20%"],"dosage_and_administration":["Directions Apply only amount needed to the oral mucosa to prevent or relieve pain. Children under 2 years of age: do not use"],"effective_time":"20240411","id":"15d7eb39-c284-291a-e063-6294a90adc6a","inactive_ingredient":["Inactive Ingredients Ethyl Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and propane)."],"indications_and_usage":["Uses For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures. For Professional Use Only."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Avoid spraying in eyes."],"openfda":{"application_number":["M022"],"brand_name":["Gelato Topical Anesthetic"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["68400-323-35"],"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":["68400-323"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["1435490","1435495"],"spl_id":["15d7eb39-c284-291a-e063-6294a90adc6a"],"spl_set_id":["9991de96-99a1-42f0-9ddd-e530ca9ceab1"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["front box label"],"purpose":["Purpose Oral Anesthetic"],"questions":["Questions or comments? 1-800-333-3131"],"set_id":"9991de96-99a1-42f0-9ddd-e530ca9ceab1","spl_product_data_elements":["Gelato Topical Anesthetic Benzocaine POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM ALCOHOL ISOBUTANE PROPANE BENZOCAINE BENZOCAINE Clear"],"storage_and_handling":["Other information Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations."],"version":"7","warnings":["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 the 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, gray or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics. Flammable. Do not use near fire or flame. Avoid smoking during use. Do not use for teething in children under 2 years of age"]}