{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "hydroquinone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "DRUG DOSAGE AND ADMINISTRATION A thin layer of Pigment Control Creme (Hydroquinone USP, 4%) should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after 8-12 weeks of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.json",
        "verbatim": true
      },
      {
        "text": "DRUG DOSAGE AND ADMINISTRATION A thin application of Pigment Control + Blending Creme should be applied to the affected area twice daily or as directed by a physician. Consult product label for instructions on whether to rub in or not. There is no recommendation for children under 12 years of age except under the advice and supervision of a physician.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness for pediatric patients below the age of 12 years have not been established.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.json",
        "verbatim": true
      },
      {
        "text": "DRUG DOSAGE AND ADMINISTRATION A thin layer of Pigment Control Creme (Hydroquinone USP, 4%) should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after 8-12 weeks of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.json",
        "verbatim": true
      },
      {
        "text": "DRUG DOSAGE AND ADMINISTRATION A thin application of Pigment Control + Blending Creme should be applied to the affected area twice daily or as directed by a physician. Consult product label for instructions on whether to rub in or not. There is no recommendation for children under 12 years of age except under the advice and supervision of a physician.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.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 hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.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 hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Category C Animal reproduction studies have not been conducted with topical hydroquinone.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.json",
        "verbatim": true
      },
      {
        "text": "It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.json",
        "verbatim": true
      },
      {
        "text": "Topical hydroquinone should be given to a pregnant woman only if clearly needed.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known whether this drug is excreted in human milk.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.",
        "source": "US FDA label for hydroquinone (ZO Skin Health Pigment Control Program Plus Hydroquinone), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/hydroquinone.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 topical hydroquinone is administered to a nursing'."
    }
  }
}