{"active_ingredient":["Benzalkonium chloride 0.13% Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%"],"dosage_and_administration":["cut open tip of tube on score mark adults and children 2 years of age and older : apply to affected area up to 4 times daily or as directed by a dentist or doctor children between 2 and 12 years of age : ask a doctor before use. Should be supervised in the use of this product children under 2 years of age : do not use"],"effective_time":"20251121","id":"441f0711-3eda-b056-e063-6294a90acb4c","inactive_ingredient":["ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide"],"indications_and_usage":["for the temporary relief of pain due to minor irritation or injury of the mouth and gums first aid to help prevent infection in minor oral irritation"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["4x Medicated Gum Cream"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Albertsons"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["21130-621-19"],"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":["21130-621"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["441f0711-3eda-b056-e063-6294a90acb4c"],"spl_set_id":["b81a308c-9c30-0e3d-e053-2a95a90a15d2"],"substance_name":["BENZALKONIUM CHLORIDE","MENTHOL, UNSPECIFIED FORM","BENZOCAINE","ZINC CHLORIDE"],"unii":["F5UM2KM3W7","L7T10EIP3A","U3RSY48JW5","86Q357L16B"]},"other_safety_information":["do not use if tip is cut prior to opening avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying"],"package_label_principal_display_panel":["Albertsons_4XMed_Cream_CtnCF_2821621R2"],"purpose":["Oral antiseptic Oral pain reliever Oral pain reliever Oral astringent"],"set_id":"b81a308c-9c30-0e3d-e053-2a95a90a15d2","spl_product_data_elements":["4x Medicated Gum Cream Benzocaine BENZALKONIUM CHLORIDE BENZALKONIUM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM AMMONIUM GLYCYRRHIZATE GLYCYRRHIZIN TITANIUM DIOXIDE SORBIC ACID POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM SACCHARIN BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 ZINC CHLORIDE ZINC CATION Cloudy white to yellow"],"version":"7","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 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 or allergic reaction, get medical help or contact a Poison Control Center right away."]}