{"active_ingredient":["Benzocaine 10% . . . Oral pain reliever Menthol 0.25% . . . Oral pain reliever"],"dosage_and_administration":["carefully remove gel cushion from blister. Gently mold with fingers until soft. Apply to the affected tooth/gum area and gently press for 5-10 seconds to mold for a comfortable fit. Gel cushion will stay in place and dissolve slowly in mouth. Adults and children 12 years of age and older: use up to 3 times daily or as directed by a dentist or doctor. Children under 12 years of age: ask a dentist or doctor. Children under 2 years of age: do not use"],"effective_time":"20251121","id":"441ec368-d742-cc10-e063-6394a90a6c66","inactive_ingredient":["cellulose gum, flavor, polyethylene glycol"],"indications_and_usage":["for the temporary relief of pain due to toothaches"],"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":["Toothache and Gum Relief Cushions"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Rite Aid"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["11822-1616-9"],"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":["11822-1616"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["441ec368-d742-cc10-e063-6394a90a6c66"],"spl_set_id":["9970d485-0b78-1438-e053-2995a90ad32c"],"substance_name":["MENTHOL","BENZOCAINE"],"unii":["L7T10EIP3A","U3RSY48JW5"]},"other_safety_information":["Do not use if blister card is broken. 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. These toothache cushions are designed to completely dissolve in place. Store at room temperature 15-30°C (59-86°F)"],"package_label_principal_display_panel":["Carton R2"],"purpose":["for the temporary relief of pain due to toothaches"],"set_id":"9970d485-0b78-1438-e053-2995a90ad32c","spl_product_data_elements":["Toothache and Gum Relief Cushions Benzocaine POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM MENTHOL MENTHOL BENZOCAINE BENZOCAINE Off white to beige Mint with menthol"],"version":"6","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 develop: * 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 * iffitation, 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."]}