{"active_ingredient":["Active Ingredient Eugenol 1.2%"],"dosage_and_administration":["Directions • Adults and children 2 to 12 years of age and older: Moisten a cotton pellet with 1 or 2 drops of the product and then apply to the cotton pellet on the applicable tooth. Avoid touching tissues other than the tooth cavity. Apply the dose not more than four times daily or as directed by a dentist or physician. • Children 2 to 12 years of age: should be supervised in the use of this product. Children under 2 years of age: use only under the advice of a dentist or physician."],"effective_time":"20241004","id":"af2ff29f-3dd2-4fde-ad17-21bc9dddde70","inactive_ingredient":["Inactive Ingredients: Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid"],"indications_and_usage":["Uses: For the temporary relief of throbbing, persistent toothache."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["505G(a)(3)"],"brand_name":["AnaDent Childrens Kanka Gel"],"generic_name":["EUGENOL"],"is_original_packager":[true],"manufacturer_name":["Belmora LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["27854-178-01"],"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":["27854-178"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["1248581"],"spl_id":["af2ff29f-3dd2-4fde-ad17-21bc9dddde70"],"spl_set_id":["9c06211c-f05a-4ce7-89e5-63a63efb7f96"],"substance_name":["EUGENOL"],"unii":["3T8H1794QW"],"upc":["0853030002793"]},"package_label_principal_display_panel":["Packaging Anadentgel-178"],"purpose":["Purpose Toothache Relief Agent"],"questions":["Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST"],"set_id":"9c06211c-f05a-4ce7-89e5-63a63efb7f96","spl_product_data_elements":["AnaDent Childrens Kanka Gel Eugenol EUGENOL EUGENOL AMMONIUM GLYCYRRHIZATE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM SORBIC ACID"],"spl_unclassified_section":["Drug Facts","PAIN RELIEF For toothaches Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 www.anadentusa.com"],"storage_and_handling":["Other Information • Do not purchase if package has been opened • Store at 46 - 90°F • Cap tightly to avoid evaporation"],"version":"2","warnings":["Warnings: For external use only. Allergy alert: Do not use if you are allergic to eugenol (clove oil). When using this product • use only in teeth with persistent throbbing pain • DO NOT SWALLOW to avoid irritation • avoid contact with eyes Do not use • for more than 7 days • more than the recommended dose Stop use and ask a dentist or doctor if • irritation persists • inflammation develops • fever and infection develop Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}