{"active_ingredient":["Active Ingredient Benzocaine 20% w/v"],"dosage_and_administration":["Directions Adults and children 2 years of age and older Using applicator, apply to affected area not more than 3 to 4 times daily Children under 2 years of age Consult a doctor"],"dosage_and_administration_table":["<table><col width=\"295\"/><col width=\"295\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Adults and children 2 years of age and older</content></td><td styleCode=\"Toprule Lrule Rrule \">Using applicator, apply to affected area not more than 3 to 4 times daily</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Children under 2 years of age</content></td><td styleCode=\"Toprule Lrule Rrule \">Consult a doctor</td></tr></tbody></table>"],"effective_time":"20241025","id":"43f87627-6147-4dc2-b4cf-1994fbfb1067","inactive_ingredient":["Inactive I ngredients Alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, PEG-8 Questions? 1-800-443-4908"],"indications_and_usage":["Use For the temporary relief of pain associated with minor skin irritations."],"keep_out_of_reach_of_children":["Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["Outgro"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Medtech Products Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["63029-531-11"],"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":["63029-531"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["43f87627-6147-4dc2-b4cf-1994fbfb1067"],"spl_set_id":["d6be8a1d-aca7-42b1-86da-881d42ffe8d5"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"other_safety_information":["Other I nformation ■ store at room temperature away from heat."],"package_label_principal_display_panel":["Principal Display Panel Outgro BENZOCAINE PAIN RELIEVING LIQUID .31 FL OZ/ 9 mL Outgro BENZOCANE PAIN RELIEVING LIQUID .31 FL OZ/ 9 mL"],"purpose":["Purpose Topical analgesic"],"questions":["Questions? 1-800-443-4908"],"set_id":"d6be8a1d-aca7-42b1-86da-881d42ffe8d5","spl_product_data_elements":["Outgro Benzocaine BENZOCAINE BENZOCAINE ALCOHOL D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 POLYETHYLENE GLYCOL 400"],"spl_unclassified_section":["Outgro® PAIN RELIEVING LIQUID Drug Facts"],"stop_use":["Stop use and ask a doctor if: ■ condition worsens ■ condition does not improve in 7 days ■ condition clears up and occurs again within a few days."],"version":"5","warnings":["Warnings ■ For external use only. ■ Extremely Flammable . Keep away from fire or flame. Avoid smoking during use and until product has dried. When using this product: avoid contact with eyes. Stop use and ask a doctor if: ■ condition worsens ■ condition does not improve in 7 days ■ condition clears up and occurs again within a few days. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product: avoid contact with eyes."]}