{
  "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": "2026-10-30",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Dermaharmony Zinc Therapy Pyrithione Zinc SODIUM CHLORIDE LAURYL GLUCOSIDE WATER COCAMIDOPROPYL HYDROXYSULTAINE SOYETHYL MORPHOLINIUM ETHOSULFATE DISTEARYL PHTHALAMIC ACID TEA TREE OIL LAURAMINE OXIDE SODIUM LAUROAMPHOACETATE ALOE VERA LEAF PHENOXYETHANOL PYRITHIONE ZINC PYRITHIONE ZINC"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: D3 Development, Inc., Portland, ME 04101 Made in USA from U.S. and imported ingredients"
      ],
      "active_ingredient": [
        "Active ingredient Pyrithione zinc 2%"
      ],
      "purpose": [
        "Purposes Dandruff, Seborrheic dermatitis"
      ],
      "indications_and_usage": [
        "Uses Controls, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis."
      ],
      "warnings": [
        "Warnings For external use only Ask a doctor before use if you have seborrheic dermatitis that covers a large portion of the body When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have seborrheic dermatitis that covers a large portion 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 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 Shake before each use Use on affected areas in place of your regular soap For best results use at least twice a week or as directed by a doctor Work up a lather using warm water and massage into affected areas Rinse well"
      ],
      "storage_and_handling": [
        "Other information Store at room temperature Lot number and expiration date on bottom"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, Lauryl Glucoside, Cocamidopropyl Hydroxysultaine, Sodium Lauroamphoacetate, Distearyl Phthalic Acid Amide, Sodium Chloride, Lauramine Oxide, Melaleuca Alternifolia (Tea Tree) Oil, Soyethyl Morpholinium Ethosulfate, Phenoxyethanol, Aloe Barbadensis Leaf Juice"
      ],
      "questions": [
        "Questions? 1-800-827-3730"
      ],
      "package_label_principal_display_panel": [
        "dermaharmony Zinc Therapy CLEANSER 2% Pyrithione Zinc for Seborrheic Dermatitis & Dandruff HELPS STOP: FLAKING, REDNESS, IRRITATION, SCALING 4 FL OZ (118 ml) 71819-016 Final"
      ],
      "set_id": "cb442483-b735-01a0-e053-2995a90aaff5",
      "id": "29bad11f-2f6c-9b3d-e063-6394a90a4f86",
      "effective_time": "20241220",
      "version": "2",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Dermaharmony Zinc Therapy"
        ],
        "generic_name": [
          "PYRITHIONE ZINC"
        ],
        "manufacturer_name": [
          "D3 Development, Inc."
        ],
        "product_ndc": [
          "71819-016"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PYRITHIONE ZINC"
        ],
        "rxcui": [
          "1048123"
        ],
        "spl_id": [
          "29bad11f-2f6c-9b3d-e063-6394a90a4f86"
        ],
        "spl_set_id": [
          "cb442483-b735-01a0-e053-2995a90aaff5"
        ],
        "package_ndc": [
          "71819-016-04",
          "71819-016-12",
          "71819-016-64",
          "71819-016-99",
          "71819-016-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R953O2RHZ5"
        ]
      }
    }
  ]
}