{"active_ingredient":["Active Ingredient Dimethicone 1% w/w"],"do_not_use":["For external use only."],"dosage_and_administration":["Directions Apply liberally as often as necessary."],"effective_time":"20241017","id":"24ade6cc-c3b3-2d87-e063-6394a90afc61","inactive_ingredient":["Inactive Ingredients Purified water, cyclomethicone, cyclomethicone aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol and polyglyceryl-4-isostearate and hexyl laurate, sodium chloride, imidurea."],"indications_and_usage":["Uses Helps prevent and temporarily protect chafed, chapped, cracked, dry skin."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M014"],"brand_name":["TheraSeal"],"generic_name":["DIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Bausch Health US, LLC"],"nui":["N0000010282"],"package_ndc":["0187-1660-06"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["0187-1660"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["200010","826807"],"spl_id":["24ade6cc-c3b3-2d87-e063-6394a90afc61"],"spl_set_id":["2c8dc616-20c1-4d33-8a89-9bcdb22b35c8"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 6 ounce label PROTECTS DAMAGED HANDS TheraSeal ® Hand Protection Protects hands from harmful irritants SKIN PROTECTANT NET WT. 6 OZ. Patented formulation PRINCIPAL DISPLAY PANEL - 6 ounce label"],"purpose":["Purpose Skin Protectant"],"questions":["Questions? 1-866-819-9007 www.CoriaLabs.com"],"set_id":"2c8dc616-20c1-4d33-8a89-9bcdb22b35c8","spl_product_data_elements":["TheraSeal Dimethicone WATER CYCLOMETHICONE POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE SODIUM CHLORIDE IMIDUREA DIMETHICONE DIMETHICONE"],"spl_unclassified_section":["Drug Facts","U.S. Patent 5482714 Distributed by: Coria Laboratories, a division of Valeant Pharmaceuticals, North America, Fort Worth, TX 76107 Manufactured by: DPT Laboratories, Ltd., San Antonio, Texas 78215 106022-0410"],"version":"4","warnings":["Warnings For external use only. When using this product avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, consult a physician. Keep out of reach of children."],"when_using":["When using this product avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, consult a physician."]}