{"active_ingredient":["Active ingredient Benzocaine 20%"],"do_not_use":["Do Not Use for teething in children under 2 years of age"],"dosage_and_administration":["Directions snip off tip of tube apply to affected area; carefully coat with a protective layer supervise children using this product adults and children 2 years and over: use up to 4 times daily or as directed by a doctor children under 2 years: do not use"],"effective_time":"20241217","id":"2979ed4e-4ce2-bd7d-e063-6294a90acb9f","inactive_ingredient":["Inactive Ingredients aloe barbadensis leaf extract, butylated hydroxytoluene, carbomer hompolymer, cetylpyridinium chloride, chamomilla recutita (matricaria) flower extract, cocos nucifera (coconut) oil, commiphora myrrha resin, dimethicone, echinacea purpurea extract, flavor, glyceryl stearate, menthol, mineral oil, silica dimethicone silylate, vitamin E, white petrolatum"],"indications_and_usage":["Uses temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures"],"keep_out_of_reach_of_children":["Keep Out of Reach of Children If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["Red Cross Canker Sore"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["The Mentholatum Company"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10742-8915-1"],"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":["10742-8915"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["244323","1489070"],"spl_id":["2979ed4e-4ce2-bd7d-e063-6294a90acb9f"],"spl_set_id":["54cfff96-6665-4b36-a15d-10bf6cf3a1f9"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel Red Cross Canker Sore Oral Anesthetic/Analgesic","Principal Display Panel"],"purpose":["Purpose Oral anesthetic/analgesic"],"set_id":"54cfff96-6665-4b36-a15d-10bf6cf3a1f9","spl_product_data_elements":["Red Cross Canker Sore benzocaine ALOE VERA LEAF BUTYLATED HYDROXYTOLUENE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYLPYRIDINIUM CHLORIDE CHAMOMILE COCONUT OIL MYRRH ECHINACEA PURPUREA GLYCERYL 1-STEARATE MENTHOL, UNSPECIFIED FORM MINERAL OIL SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL PETROLATUM BENZOCAINE BENZOCAINE"],"stop_use":["Stop use and ask a doctor if sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops"],"version":"4","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 for teething in children under 2 years of age When using this product do not use for more than 7 days unless directed by a dentist or doctor do not exceed recommended dosage Stop use and ask a doctor if sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops"],"when_using":["When using this product do not use for more than 7 days unless directed by a dentist or doctor do not exceed recommended dosage"]}