{"active_ingredient":["Active Ingredients (in each gram) Benzocaine 200mg"],"dosage_and_administration":["Directions Apply only amount needed to the oral mucosa to prevent or relieve pain."],"effective_time":"20251217","id":"462b9b39-e937-5526-e063-6294a90a776c","inactive_ingredient":["Inactive Ingredients flavoring, PEG 3350, PEG 400, sodium saccharin. May contain yellow #5 (tartrazine), yellow #6, red #3, red #40, blue #1, green #3 as a color additive."],"indications_and_usage":["Use For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures."],"keep_out_of_reach_of_children":["​Keep out of reach of children."],"openfda":{"application_number":["M022"],"brand_name":["Ipana 20% Benzocaine Topical"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Maxill Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["69510-352-30"],"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":["69510-352"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["238910"],"spl_id":["462b9b39-e937-5526-e063-6294a90a776c"],"spl_set_id":["9de36e4f-f966-4a58-b4bf-9ac3b86b3f09"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["LB.ipana-Topical-Gel-Wrap_US.jpg"],"purpose":["Purpose Oral Anesthetic"],"questions":["Questions? 1-855-462-9455 or 1-519-631-7370"],"set_id":"9de36e4f-f966-4a58-b4bf-9ac3b86b3f09","spl_product_data_elements":["Ipana 20% Benzocaine Topical Benzocaine FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 FD&C RED NO. 3 FD&C RED NO. 40 FD&C BLUE NO. 1 FD&C GREEN NO. 3 BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM"],"storage_and_handling":["Other Information Store at 59°-86°F (15°-30°C). Protect from freezing."],"version":"9","warnings":["Warnings ​Allergy alert: ​Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other \"caine\" anesthetics. ​Do not use ​for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly. ​When using this product ​avoid contact with eyes. If contact occurs, flush with water. ​Stop use and consult a health care practitioner ​if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. ​Do not exceed recommended dosage. ​If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately. ​If pregnant or breastfeeding, ​ask a health professional before use."]}