{
  "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": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Dermaharmony Face and Body Pyrithione Zinc STEARETH-20 ALPHA-TOCOPHEROL ACETATE FERRIC OXIDE YELLOW DISODIUM 2-SULFOLAURATE OATMEAL ARGAN OIL WATER SODIUM ISOSTEAROYL LACTYLATE COCO GLUCOSIDE SODIUM COCOYL ISETHIONATE STEARIC ACID COCONUT ACID SOYETHYL MORPHOLINIUM ETHOSULFATE CETOSTEARYL ALCOHOL OLIVE OIL SODIUM METHYL 2-SULFOLAURATE SODIUM ISETHIONATE SUCROSE COCOATE 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: 71819-008-04"
      ],
      "active_ingredient": [
        "Active ingredient Pyrithione zinc 2%"
      ],
      "purpose": [
        "Purpose Dandruff / Seborrheic dermatitis"
      ],
      "indications_and_usage": [
        "Uses 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 soap / 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 body / hair Massage into the skin or 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, coco glucoside, water, soyethyl morpholinium ethosulfate, cetearyl alcohol & ceteareth-20, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, oat (Avena Sativa) flour, sucrose cocoate, olive oil, tocopheryl acetate (vitamin E), sodium isostearoyl lactylate, iron oxides (yellow)."
      ],
      "questions": [
        "Questions? 1-800-827-3730 www.dermaharmony.com"
      ],
      "package_label_principal_display_panel": [
        "dermaharmony Face & Body with 2% Pyrithione Zinc FOR DANDRUFF & SEBORRHEIC DERMATITIS Reduces itching-irritation-redness-flaking-scaling NET WT 4 OZ (113G) Face-Body-Bar-V3"
      ],
      "set_id": "bd72b53c-b22c-40d0-e053-2995a90af9c1",
      "id": "29ba89f0-e6fb-0811-e063-6294a90a288c",
      "effective_time": "20241220",
      "version": "2",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Dermaharmony Face and Body"
        ],
        "generic_name": [
          "PYRITHIONE ZINC"
        ],
        "manufacturer_name": [
          "D3 Development, Inc."
        ],
        "product_ndc": [
          "71819-008"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PYRITHIONE ZINC"
        ],
        "rxcui": [
          "283707"
        ],
        "spl_id": [
          "29ba89f0-e6fb-0811-e063-6294a90a288c"
        ],
        "spl_set_id": [
          "bd72b53c-b22c-40d0-e053-2995a90af9c1"
        ],
        "package_ndc": [
          "71819-008-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R953O2RHZ5"
        ]
      }
    }
  ]
}