{"active_ingredient":["Active ingredient Purpose Benzocaine 20%............................................Oral Pain Reliever"],"do_not_use":["Do not use more than directed for more than 7 days unless directed by a doctor for teething in children under 2 years of age"],"dosage_and_administration":["Distributed by: United Exchange Corp. 5836 Corporate Ave. Cypress, CA 90630 USA 1-800-814-8028 Made in China"],"effective_time":"20251030","id":"4262e1af-6041-bc2d-e063-6294a90a006f","inactive_ingredient":["Inactive ingredients glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol"],"indications_and_usage":["Directions Adults and children 2 years of age and older. Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around 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."],"indications_and_usage_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Adults and children 2 years of age and older.</td><td>Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.</td></tr><tr><td>Children under 12 years of age.</td><td>Should be supervised 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>"],"keep_out_of_reach_of_children":["Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M022"],"brand_name":["Iodent Oral Analgesic"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["United Exchange Corp."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["65923-094-11"],"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":["65923-094"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["238910"],"spl_id":["4262e1af-6041-bc2d-e063-6294a90a006f"],"spl_set_id":["63902125-f8dc-0ada-e053-2991aa0a7ce5"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"],"upc":["0831527004901"]},"package_label_principal_display_panel":["480.1"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Uses for the temporary relief of pain due to: toothache canker sores gum pain denture pain cheek bites"],"set_id":"63902125-f8dc-0ada-e053-2991aa0a7ce5","spl_product_data_elements":["Iodent Oral Analgesic Benzocaine SACCHARIN SODIUM SACCHARIN SORBITOL BENZOCAINE BENZOCAINE GLYCERIN PEPPERMINT OIL PEPPERMINT POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 4000"],"stop_use":["Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness does not go away swelling, rash or fever develops"],"storage_and_handling":["Other information store at room temperature 20° to 25°C (68° to 77°) this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist or doctor can be consulted do not use continuously"],"version":"8","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 your child has a history of allergy or local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics."]}