{"active_ingredient":["Active Ingredient Benzocaine 20%"],"dosage_and_administration":["Directions Cut open tip of tube on score mark Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: do not use"],"effective_time":"20241004","id":"36e537e0-993c-42d9-ac41-227cdcd5dfe3","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 pain due to toothache To help protect against infection of minor oral irritation."],"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."],"openfda":{"application_number":["M022"],"brand_name":["Anadent Kanka Gel"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["BELMORA LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["27854-177-01"],"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":["27854-177"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["238910"],"spl_id":["36e537e0-993c-42d9-ac41-227cdcd5dfe3"],"spl_set_id":["e0f73d78-5db1-43b4-8f58-e5410ca4560f"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Packaging BELMORA-177"],"purpose":["Purpose oral pain reliever"],"set_id":"e0f73d78-5db1-43b4-8f58-e5410ca4560f","spl_product_data_elements":["Anadent Kanka Gel Benzocaine BENZOCAINE BENZOCAINE AMMONIUM GLYCYRRHIZATE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM SORBIC ACID"],"spl_unclassified_section":["Drug Facts","20% BENZOCAINE TO RELIEVE ORAL PAIN COOLS GUM & RELIEVES IRRITATION For toothaches Toothache and Gum pain Relief Gel TAMPER-EVIDENT: Do not use if tube is cut prior to use. Retain carton for complete product information. Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 | www.anadentusa.com Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST"],"storage_and_handling":["Other Information Do not use if tip is cut prior to opening This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted Do not use continuously This formula will stay in place for extended duration of relief Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying"],"version":"2","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 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics Do not use more than directed • for more than 7 days unless told to do so by a dentist or doctor for teething • in children under 2 years of age Stop use and ask a dentist or doctor if swelling, rash or fever develops • irritation, pain or redness persists or worsens symptoms do not improve in 7 days • allergic reaction occurs Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away."]}