{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "clobetasol propionate",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Clobetasol Propionate Shampoo, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use. Clobetasol Propionate Shampoo, 0.05% should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.",
        "source": "US FDA label for clobetasol propionate (clobetasol propionate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Use of clobetasol propionate shampoo, 0.05% in patients under 18 years old is not recommended due to potential for HPA axis suppression [see Warnings and Precautions ( 5.1 )] The effect of clobetasol propionate shampoo, 0.05% on HPA axis suppression was evaluated in one trial in adolescents 12 to 17 years of age with moderate to severe scalp psoriasis with involvement of at least 25% of the scalp.",
        "source": "US FDA label for clobetasol propionate (clobetasol propionate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.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 clobetasol propionate (clobetasol propionate), retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.",
        "source": "US FDA label for clobetasol propionate (clobetasol propionate), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Teratogenic effects: Pregnancy Category C.",
        "source": "US FDA label for clobetasol propionate (clobetasol propionate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.json",
        "verbatim": true
      },
      {
        "text": "There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for clobetasol propionate (clobetasol propionate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.json",
        "verbatim": true
      },
      {
        "text": "Therefore, clobetasol propionate shampoo, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.",
        "source": "US FDA label for clobetasol propionate (clobetasol propionate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.",
        "source": "US FDA label for clobetasol propionate (clobetasol propionate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.json",
        "verbatim": true
      },
      {
        "text": "It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.",
        "source": "US FDA label for clobetasol propionate (clobetasol propionate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate shampoo, 0.05% is administered to a nursing woman.",
        "source": "US FDA label for clobetasol propionate (clobetasol propionate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/clobetasol-propionate.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "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: 'should be used during pregnancy only if'."
    },
    "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 clobetasol propionate shampoo, 0.05% is administered to a nursing'."
    }
  }
}