{"active_ingredient":["Active ingredient Benzocaine 10%"],"dosage_and_administration":["Directions adults and children 2 years and older Dry affected area. Apply a thin coat of gel with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds. children under 12 years adult supervision should be given in the use of this product children under 2 years do not use, consult a physician or dentist"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"25.000%\" align=\"left\"/><col width=\"75.000%\" align=\"left\"/><tbody><tr><td align=\"left\" styleCode=\"Toprule Botrule Rrule\" valign=\"top\">adults and children   2 years and older </td><td align=\"left\" styleCode=\"Toprule Botrule\" valign=\"top\">Dry affected area. Apply a thin coat of gel with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds.</td></tr><tr><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">children under 12 years</td><td align=\"left\" styleCode=\"Botrule\" valign=\"top\">adult supervision should be given in the use of this product</td></tr><tr><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">children under 2 years</td><td align=\"left\" styleCode=\"Botrule\" valign=\"top\">do not use, consult a physician or dentist</td></tr></tbody></table>"],"effective_time":"20251106","id":"42eec176-84ad-1e81-e063-6394a90afd01","inactive_ingredient":["Inactive ingredients Boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 38-B, tannic acid"],"indications_and_usage":["Use temporarily relieves pain caused by: canker sores minor mouth sores and gum irritations denture and brace pain"],"keep_out_of_reach_of_children":["Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately."],"openfda":{"application_number":["M022"],"brand_name":["Zilactin-B"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["ASCENT CONSUMER PRODUCTS, INC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["42829-550-32"],"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":["42829-550"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["198488","1542803"],"spl_id":["42eec176-84ad-1e81-e063-6394a90afd01"],"spl_set_id":["42eeb3d4-bac6-4e29-e063-6294a90a644d"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["ZB"],"purpose":["Purpose Oral pain reliever"],"questions":["Call 1-888-547-5492 Distributed by Ascent Consumer Products"],"set_id":"42eeb3d4-bac6-4e29-e063-6294a90a644d","spl_product_data_elements":["Zilactin-B benzocaine BORIC ACID HYDROXYPROPYL CELLULOSE (TYPE M) PROPYLENE GLYCOL SALICYLIC ACID ALCOHOL PEPPERMINT OIL TANNIC ACID WATER BENZOCAINE BENZOCAINE"],"spl_unclassified_section":["Drug Facts","Other information do not peel off protective film. Attempting to peel off film may result in skin irritation or tenderness. To remove film, first apply another coat of Zilactin-B Long Lasting Mouth Sore Gel to film, and immediately wipe the area with a moist gauze pad or tissue. contains alcohol 65% by volume store at 15-30°C (59-86°F)"],"stop_use":["Stop use and ask a physician if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens apply only to affected area do not exceed recommended dosage avoid contact with the eyes do not use for more than 7 days unless directed by a physician or dentist"],"version":"1","warnings":["Warnings Flammable: keep away from fire or flame Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics Stop use and ask a physician if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens apply only to affected area do not exceed recommended dosage avoid contact with the eyes do not use for more than 7 days unless directed by a physician or dentist Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately."]}