{"active_ingredient":["Benzocaine 20% . . . Oral pain reliever Menthol 0.1% . . . Oral pain reliever Zinc chloride 0.15% . . . Oral astringent"],"dosage_and_administration":["Directions cut open tip of tube on score mark * do not use if tip is cut prior to opening * 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 under 12 years of age shoul dbe supervised in the use of this product * children under 2 years of age: do not use"],"effective_time":"20251113","id":"437fc6af-b61e-b18e-e063-6294a90a75b7","inactive_ingredient":["allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water"],"indications_and_usage":["Uses temporarily relives pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums"],"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":["3x Medicated Mouth Sore Gel"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["CVS"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["69842-660-09"],"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":["69842-660"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2266762"],"spl_id":["437fc6af-b61e-b18e-e063-6294a90a75b7"],"spl_set_id":["a7572c4f-089b-0e80-e053-2a95a90a0ddf"],"substance_name":["BENZOCAINE","MENTHOL, UNSPECIFIED FORM","ZINC CHLORIDE"],"unii":["U3RSY48JW5","L7T10EIP3A","86Q357L16B"]},"package_label_principal_display_panel":["Carton Artwork"],"purpose":["Uses temporarily relives pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums"],"set_id":"a7572c4f-089b-0e80-e053-2a95a90a0ddf","spl_product_data_elements":["3x Medicated Mouth Sore Gel Benzocaine BENZOCAINE BENZOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ZINC CHLORIDE ZINC CATION POLYETHYLENE GLYCOL 400 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) PROPYLENE GLYCOL POVIDONE K90 SORBIC ACID STEARYL ALCOHOL ALLANTOIN WATER EDETATE DISODIUM EDETIC ACID POLYSORBATE 60 SACCHARIN SODIUM SACCHARIN METHYL SALICYLATE Clear to yellow tint"],"stop_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"],"version":"5","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."]}