{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "ivermectin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Apply to the affected areas of the face once daily. Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer, avoiding the eyes and lips. Ivermectin cream is not for oral, ophthalmic, or intravaginal use. Apply to the affected areas once daily. ( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )",
        "source": "US FDA label for ivermectin (IVERMECTIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness of Ivermectin cream in pediatric patients have not been established.",
        "source": "US FDA label for ivermectin (IVERMECTIN), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.json",
        "verbatim": true
      }
    ],
    "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 ivermectin (IVERMECTIN), retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.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 ivermectin (IVERMECTIN), retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary The available data on the use of ivermectin, including Ivermectin cream, in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for ivermectin (IVERMECTIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant rats and rabbits during the period of organogenesis at doses 1909 or 354 times the maximum recommended human dose (MRHD), respectively.",
        "source": "US FDA label for ivermectin (IVERMECTIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.json",
        "verbatim": true
      },
      {
        "text": "These orally administered doses were maternally toxic to pregnant rats and rabbits.",
        "source": "US FDA label for ivermectin (IVERMECTIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary The presence of ivermectin in human milk following topical administration of ivermectin has not been evaluated.",
        "source": "US FDA label for ivermectin (IVERMECTIN), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.json",
        "verbatim": true
      },
      {
        "text": "There are no data available regarding the effects of ivermectin on milk production.",
        "source": "US FDA label for ivermectin (IVERMECTIN), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.json",
        "verbatim": true
      },
      {
        "text": "Published literature suggests that ivermectin was detectable in human milk in 4 lactating women after a single 150 mcg/kg oral dose of ivermectin.",
        "source": "US FDA label for ivermectin (IVERMECTIN), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ivermectin.json",
        "verbatim": true
      }
    ]
  }
}