{"active_ingredient":["Benzalkonium chloride 0.13% . . . Oral antiseptic Benzocaine 20% . . . Oral pain reliever Menthol 0.5% . . . Oral pain reliever Zinc chloride 0.15% . . . Oral astringent"],"do_not_use":["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"],"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":"20200605","id":"a757d19a-e4ea-69d6-e053-2a95a90a72ca","inactive_ingredient":["ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide"],"indications_and_usage":["Use for the temporary relief of pain due to toothaches * 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":{},"other_safety_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 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"],"package_label_principal_display_panel":["NBE Carton Artwork"],"purpose":["Use for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation"],"set_id":"a757d19a-e4e9-69d6-e053-2a95a90a72ca","spl_product_data_elements":["4x Medicated Toothache and Gum Cream Benzocaine SORBIC ACID POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM SACCHARIN BENZALKONIUM CHLORIDE BENZALKONIUM AMMONIUM GLYCYRRHIZATE GLYCYRRHIZIN BENZOCAINE BENZOCAINE ZINC CHLORIDE ZINC CATION MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM TITANIUM DIOXIDE Cloudy White"],"version":"1","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, get medical help or contact a Poison Control Center right away."]}