{"active_ingredient":["Active Ingredient (in each gram) Benzocaine 200mg"],"dosage_and_administration":["Directions Apply only amount needed to the oral mucosa to prevent or relieve pain."],"effective_time":"20190219","id":"4d6dfbbd-e499-4bcf-b0ea-bdd6079cb348","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":{},"package_label_principal_display_panel":["FIDELISTAGELGENERIC"],"purpose":["Purpose Oral Anesthetic"],"questions":["Questions or comments? (727) 862-3282"],"set_id":"4796d0c0-a99a-4f51-8ce1-0721e359158a","spl_product_data_elements":["FIDELIS Topical Anesthetic Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM 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"],"storage_and_handling":["Other Information Store at 59° - 86°F (15°-30°C). Protect from freezing."],"version":"2","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."]}