{"active_ingredient":["Active Ingredient: Dibucaine 1%"],"dosage_and_administration":["Directions: not for prolonged use adults should not use more than the tube in 24 hours or 1/4 tube for child apply to affected area 3 or 4 times daily cover with light dressing, if necessary"],"effective_time":"20120725","id":"cc66c053-6c73-4d9b-979b-f508f7c0aa5c","inactive_ingredient":["Inactive Ingredients acetone sodium bisulfite 1/2% as a preservative, lanolin, purified water, white petrolatum"],"indications_and_usage":["Uses: for temporary relief of pain and itching associated with: sunburn minor burns hemorrhoids cuts scratches insect bites stings"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER Fougera ® NDC 0168-0046-31 CHILD-RESISTANT PACKAGE DIBUCAINE OINTMENT USP, 1% TOPICAL ANESTHETIC NET WT 28.35g (1 Oz) FOR EXTERNAL USE ONLY DO NOT USE IN THE EYES PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON NDC 0168-0046-31 Fougera ® DIBUCAINE OINTMENT USP, 1% TOPICAL ANESTHETIC NET WT 28.35g (1 Oz) Laminate Tube with Child-Resistant Cap FOR EXTERNAL USE ONLY DO NOT USE IN THE EYES PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON"],"purpose":["Purpose: Topical Anesthetic"],"set_id":"8ae5992a-c544-4fd8-93f8-0f97c653203c","spl_product_data_elements":["DIBUCAINE DIBUCAINE DIBUCAINE DIBUCAINE ACETONE SODIUM BISULFITE LANOLIN PETROLATUM WATER"],"spl_unclassified_section":["Other information: store at room temperature. see crimp of tube for Lot Number and Expiration Date.","Questions or comments? call toll free 1-800-645-9833 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, NY 11747 C4905B R12/11"],"version":"1","warnings":["Warnings: For external use only Do not use in the eyes Stop use and ask a doctor if the condition persists or if rash or irritation develops you have rectal bleeding"]}