{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "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"
      ],
      "active_ingredient": [
        "Active Ingredient Dimethicone 1% w/w"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps prevent and temporarily protect chafed, chapped, cracked, dry skin."
      ],
      "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."
      ],
      "do_not_use": [
        "For external use only."
      ],
      "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."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Directions Apply liberally as often as necessary."
      ],
      "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."
      ],
      "questions": [
        "Questions? 1-866-819-9007 www.CoriaLabs.com"
      ],
      "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"
      ],
      "set_id": "2c8dc616-20c1-4d33-8a89-9bcdb22b35c8",
      "id": "24ade6cc-c3b3-2d87-e063-6394a90afc61",
      "effective_time": "20241017",
      "version": "4",
      "openfda": {
        "application_number": [
          "M014"
        ],
        "brand_name": [
          "TheraSeal"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Bausch Health US, LLC"
        ],
        "product_ndc": [
          "0187-1660"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "200010",
          "826807"
        ],
        "spl_id": [
          "24ade6cc-c3b3-2d87-e063-6394a90afc61"
        ],
        "spl_set_id": [
          "2c8dc616-20c1-4d33-8a89-9bcdb22b35c8"
        ],
        "package_ndc": [
          "0187-1660-06"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}