{"active_ingredient":["Active Ingredient Dibucaine 1%"],"do_not_use":["Do Not Use In or near eyes In children under 2 years of age"],"dosage_and_administration":["Directions Adults and children 12 years of age or older. If possible, clean the affected area by platting or blotting with an appropriate cleansing wipe, gently dry by patting or blotting with a tissue or a soft cloth before applying. Apply externally to the affected area up to 3 to 4 times daily. Children under 12 years of age. ask a doctor"],"effective_time":"20240102","id":"0df7b6dd-a4d8-c9a6-e063-6394a90a0f52","inactive_ingredient":["Inactive Ingredients Lanolin, Light Mineral Oil, Purified Water, White Petrolatum"],"indications_and_usage":["Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders."],"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":["Dibucaine"],"generic_name":["DIBUCAINE 1%"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals USA LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["69396-023-01"],"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":["69396-023"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["238784"],"spl_id":["0df7b6dd-a4d8-c9a6-e063-6394a90a0f52"],"spl_set_id":["e8a56651-a292-7609-e053-2a95a90a7c36"],"substance_name":["DIBUCAINE"],"unii":["L6JW2TJG99"],"upc":["0850026393415"]},"package_label_principal_display_panel":["Packaging globe-dibucaine-1oz-CDER"],"pregnancy_or_breast_feeding":["If Pregnant or Breast-Feeding Ask a health care professional before use."],"purpose":["Hemorrhoidal Ointment"],"questions":["Questions or Comments? Call Toll Free 1-888-296-9067"],"set_id":"e8a56651-a292-7609-e053-2a95a90a7c36","spl_product_data_elements":["Dibucaine Dibucaine 1% PETROLATUM WATER LIGHT MINERAL OIL LANOLIN DIBUCAINE DIBUCAINE"],"spl_unclassified_section":["Drug Facts","Distributed By Trifecta Pharmaceuticals USA 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA 1-888-296-9067 Made in China * This product is not manufactured or distributed by Ducere Pharma, Distributor of Nuper-Cainal Child Resistant Packaging"],"stop_use":["Stop Use and ask a doctor Bleeding occurs Condition worsens or does not improve within 7 days"],"storage_and_handling":["Other Information Store at room temperature 20º-25ºC (68º-77ºF)"],"version":"2","warnings":["Warnings For External use only Allergy alert Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated do not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor."],"when_using":["When using this product Do not use more than directed unless directed by a doctor Do not put this product into the rectum by using fingers or any mechanical device or applicator."]}