{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "urea",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Apply Urea 40% 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. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.",
        "source": "US FDA label for urea (Urea Cream 40%), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/urea.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "No child dose in this label. That usually means untested in children, not unsuitable - use a paediatric source.",
        "source": "Read and found silent: the US FDA label for urea (Urea Cream 40%), retrieved 2026-08-29",
        "cached_file": "labels/urea.json",
        "verbatim": false
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for urea (Urea Cream 40%), retrieved 2026-08-29",
        "cached_file": "labels/urea.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for urea (Urea Cream 40%), retrieved 2026-08-29",
        "cached_file": "labels/urea.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for urea (Urea Cream 40%), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/urea.json",
        "verbatim": true
      },
      {
        "text": "Because animal reproductive studies are not always predictive of human response, Urea 40% should be given to a pregnant woman only if clearly needed.",
        "source": "US FDA label for urea (Urea Cream 40%), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/urea.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known whether or not this drug is excreted in human milk.",
        "source": "US FDA label for urea (Urea Cream 40%), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/urea.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are excreted in human milk, caution should be exercised when Urea 40% is administered to a nursing woman.",
        "source": "US FDA label for urea (Urea Cream 40%), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/urea.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "lactation": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'caution should be exercised when Urea 40% is administered to a nursing'."
    }
  }
}