{
  "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,
      "limit": 1,
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    }
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  "results": [
    {
      "spl_product_data_elements": [
        "Dermaharmony Tea Tree Bar Pyrithione Zinc OATMEAL TEA TREE OIL DEHYDROACETIC ACID ARGAN OIL DISODIUM 2-SULFOLAURATE BENZYL ALCOHOL WATER SODIUM ISOSTEAROYL LACTYLATE COCO GLUCOSIDE SODIUM COCOYL ISETHIONATE STEARIC ACID COCONUT ACID SOYETHYL MORPHOLINIUM ETHOSULFATE CETOSTEARYL ALCOHOL SODIUM METHYL 2-SULFOLAURATE SODIUM ISETHIONATE SUCROSE COCOATE POLYOXYL 20 CETOSTEARYL ETHER FERRIC OXIDE YELLOW PYRITHIONE ZINC PYRITHIONE ZINC"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: D3 Development, Inc., Portland, ME 04101 Made in USA of U.S. and imported ingredients. NDC Code: 71819-018-04"
      ],
      "active_ingredient": [
        "Active ingredient Pyrithione zinc 2%"
      ],
      "purpose": [
        "Purpose Dandruff / seborrheic dermatitis shampoo"
      ],
      "indications_and_usage": [
        "Uses Controls and reduces the symptoms of dandruff and seborrheic dermatitis."
      ],
      "warnings": [
        "Warnings For external use only Ask a doctor before use if you have a condition that covers a large area 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 a condition that 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 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 Use on affected areas in place of your regular shampoo For best results use at least twice a week or as directed by a doctor Rub between hands to create a lather, or apply bar directly onto hair Massage into the hair and scalp for 60-90 seconds, then rinse well"
      ],
      "storage_and_handling": [
        "Other information Store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, tea tree (Melaleuca Alternifolia) leaf oil, water, soyethyl morpholinium ethosulfate, coco glucoside, cetearyl alcohol & ceteareth-20, benzyl alcohol, dehydroacetic acid, oat (Avena Sativa) flour, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, sucrose cocoate, sodium isostearoyl lactylate, iron oxides (ochre)."
      ],
      "questions": [
        "Questions? 1-800-827-3730 www.dermaharmony.com"
      ],
      "package_label_principal_display_panel": [
        "dermaharmony TEA TREE Shampoo Bar with 2% Pyrithione Zinc FOR DANDRUFF & SEBORRHEIC DERMATITIS NET WT 4 OZ (113G) Dandruff Shampoo 71819-018-04"
      ],
      "set_id": "e9d5eb14-1840-ae21-e053-2a95a90aa321",
      "id": "29bad356-6711-ee98-e063-6394a90adc73",
      "effective_time": "20241220",
      "version": "2",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Dermaharmony Tea Tree Bar"
        ],
        "generic_name": [
          "PYRITHIONE ZINC"
        ],
        "manufacturer_name": [
          "D3 Development, Inc."
        ],
        "product_ndc": [
          "71819-018"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PYRITHIONE ZINC"
        ],
        "rxcui": [
          "244458"
        ],
        "spl_id": [
          "29bad356-6711-ee98-e063-6394a90adc73"
        ],
        "spl_set_id": [
          "e9d5eb14-1840-ae21-e053-2a95a90aa321"
        ],
        "package_ndc": [
          "71819-018-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R953O2RHZ5"
        ]
      }
    }
  ]
}