{
  "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": "2026-04-24",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Urea 41% Urea CETEARETH-20 CETYL ALCOHOL PARAFFIN PROPYLENE GLYCOL WATER C13-14 ISOPARAFFIN XANTHAN GUM UREA UREA POLYACRYLAMIDE (10000 MW) PHENOXYETHANOL LAURETH-7 ETHYLHEXYLGLYCERIN"
      ],
      "indications_and_usage": [
        "INDICATIONS & USAGE For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails."
      ],
      "contraindications": [
        "CONTRAINDICATIONS This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product."
      ],
      "warnings": [
        "WARNINGS Avoid contact with eyes, lips and mucous membranes."
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS: Discontinue use and consult a physician if redness or irritation occurs."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION Apply Urea 41% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician."
      ],
      "how_supplied": [
        "HOW SUPPLIED Urea 41% Cream 8 oz. (227 g): NDC 85477-905-30"
      ],
      "safe_handling_warning": [
        "STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."
      ],
      "package_label_principal_display_panel": [
        "Urea 41% Cream™ Distributed by Oncora Pharma Dallas, TX 75161 label"
      ],
      "set_id": "37576876-738c-ac79-e063-6394a90a84fe",
      "id": "37576876-738d-ac79-e063-6394a90a84fe",
      "effective_time": "20250611",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Urea 41%"
        ],
        "generic_name": [
          "UREA"
        ],
        "manufacturer_name": [
          "Oncora Pharma, LLC"
        ],
        "product_ndc": [
          "85477-905"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "UREA"
        ],
        "rxcui": [
          "1436933"
        ],
        "spl_id": [
          "37576876-738d-ac79-e063-6394a90a84fe"
        ],
        "spl_set_id": [
          "37576876-738c-ac79-e063-6394a90a84fe"
        ],
        "package_ndc": [
          "85477-905-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8W8T17847W"
        ]
      }
    }
  ]
}