{"active_ingredient":["Active ingredients Benzocaine 20%"],"dosage_and_administration":["Directions adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age adult supervision should be given in the use of this product children under 2 years of age do not use For denture irritation: apply thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting"],"dosage_and_administration_table":["<table border=\"1\" width=\"100%\"><tbody><tr><td>adults and children 2 years of age and over</td><td>apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist</td></tr><tr><td>children under 12 years of age</td><td>adult supervision should be given in the use of this product</td></tr><tr><td>children under 2 years of age</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20251008","id":"40ab3bb4-cbc0-b9e1-e063-6294a90a5a0f","inactive_ingredient":["Inactive ingredients benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid"],"indications_and_usage":["Uses temporarily relieves pain associated with the following mouth and gum irritations: toothache canker sores minor dental procedures dentures sore gums braces"],"keep_out_of_reach_of_children":["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":["Family Wellness Oral Pain Relief"],"generic_name":["BENZOCAINE 20%"],"is_original_packager":[true],"manufacturer_name":["FAMILY DOLLAR SERVICES INC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["55319-108-14"],"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":["55319-108"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["238910"],"spl_id":["40ab3bb4-cbc0-b9e1-e063-6294a90a5a0f"],"spl_set_id":["105d87d6-9147-43d4-e063-6394a90a57ee"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"other_safety_information":["Other information store at 20-25°C (68-77°F) do not refrigerate"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL"],"purpose":["Purpose Oral pain reliever"],"set_id":"105d87d6-9147-43d4-e063-6394a90a57ee","spl_product_data_elements":["Family Wellness Oral Pain Relief Benzocaine 20% BENZOCAINE BENZOCAINE GLYCERIN POLYSORBATE 80 PROPYLENE GLYCOL SACCHARIN SODIUM D&C RED NO. 33 FD&C YELLOW NO. 6 BENZYL ALCOHOL FD&C BLUE NO. 1 CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE POLYETHYLENE GLYCOL, UNSPECIFIED SORBIC ACID"],"stop_use":["Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness lasts or worsens swelling, rash, or fever develops"],"version":"3","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: avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness lasts or worsens swelling, rash, or fever develops 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."],"when_using":["When using this product: avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist"]}