{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Dermaharmony Seborrheic Dermatitis Pyrithione Zinc PHENOXYETHANOL YELLOW WAX GLYCERIN CAPRYLYL GLYCOL TOCOPHEROL HYDROXYETHYL CELLULOSE (1800 MPA.S AT 2%) STEARYL ALCOHOL ALMOND OIL WATER AVOCADO OIL CETYL ALCOHOL COCONUT OIL CASTOR OIL BEHENTRIMONIUM METHOSULFATE SHEA BUTTER MANGIFERA INDICA SEED BUTTER PYRITHIONE ZINC PYRITHIONE ZINC"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: D3 Development, Inc. Portland, ME 04101"
      ],
      "active_ingredient": [
        "Active ingredient Pyrithione zinc 0.25%"
      ],
      "purpose": [
        "Purpose Seborrheic dermatitis cream"
      ],
      "indications_and_usage": [
        "Uses Relieves skin and/or scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis Helps eliminate recurrence of seborrheic dermatitis"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "ask_doctor": [
        "Ask a doctor before use if condition covers a large area of the body."
      ],
      "when_using": [
        "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Apply to affected area one to four times daily"
      ],
      "storage_and_handling": [
        "Other information Store at 59° to 77°F (15° to 25°C) Lot number and expiration date can be found on lid."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, prunus amygdalus dulcis (sweet almond) oil, persea gratissima (avocado) oil, behentrimonium methosulfate, cetyl alcohol, glycerin, coco nucifera (coconut) oil, ricinus communis (castor) oil, stearyl alcohol, beeswax, shea butter, mango seed butter, phenoxyethanol, caprylyl glycol, tocopherol (vitamin E), hydroxyethylcellulose"
      ],
      "questions": [
        "Questions? 1-800-827-3730 www.dermaharmony.com"
      ],
      "package_label_principal_display_panel": [
        "dermaharmony Seborrheic Dermatitis CREAM Contains 0.25% Pyrithione Zinc 3 FL OZ (89 ml) Seb Derm Cream FINAL"
      ],
      "set_id": "8d81521d-9e6f-1acf-e053-2995a90a9242",
      "id": "29ba17fa-1175-3c2b-e063-6394a90a0d4c",
      "effective_time": "20241220",
      "version": "3",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Dermaharmony Seborrheic Dermatitis"
        ],
        "generic_name": [
          "PYRITHIONE ZINC"
        ],
        "manufacturer_name": [
          "D3 Development, Inc."
        ],
        "product_ndc": [
          "71819-002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PYRITHIONE ZINC"
        ],
        "rxcui": [
          "259549"
        ],
        "spl_id": [
          "29ba17fa-1175-3c2b-e063-6394a90a0d4c"
        ],
        "spl_set_id": [
          "8d81521d-9e6f-1acf-e053-2995a90a9242"
        ],
        "package_ndc": [
          "71819-002-03",
          "71819-002-06",
          "71819-002-08"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R953O2RHZ5"
        ]
      }
    }
  ]
}