{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "RoyceDerm Tea Tree Therapeutic Salicylic Acid 3% SODIUM BENZOATE POTASSIUM SORBATE CITRIC ACID SODIUM LAURETH SULFATE ALOE BARBADENSIS LEAF JUICE MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL PANTHENOL SALICYLIC ACID SALICYLIC ACID SODIUM CHLORIDE GLYCERIN COCAMIDOPROPYL BETAINE"
      ],
      "active_ingredient": [
        "Salicylic Acid 3%"
      ],
      "purpose": [
        "Anti-dandruff, anti-psoriasis, anti-seborrheic dermatitis"
      ],
      "indications_and_usage": [
        "Helps control dandruff Relieves itching, scaling, and flaking associated with dandruff"
      ],
      "warnings": [
        "For external use only Do not use it on damaged or inflamed scalp. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. If condition worsens or does not improve after regular use. If children under 12 years old, and pregnant or breast-feeding. If swallowed, get medical help or contact a posion control center. Keep out of reach of Children."
      ],
      "when_using": [
        "Do not use it on damaged or inflamed scalp. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water."
      ],
      "ask_doctor": [
        "If condition worsens or does not improve after regular use. If children under 12 years old, and pregnant or breast-feeding. If swallowed, get medical help or contact a posion control center."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of Children."
      ],
      "dosage_and_administration": [
        "Apply shampoo, massage into the scalp, and leave on hair for 3-5 minutes to allow maximum absorption. Then rinse thoroughly and repeat as needed. For best results, use at least twice a week or as directed by a doctor."
      ],
      "inactive_ingredient": [
        "Aqua, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Cocoyl Glycinate, Cocamidopropyl Betaine, Cocamide MEA, Cocamide Methyl MEA, Sodium Chloride, Glycol Distearate, Acrylates Copolymer, Cetearyl Alcohol, Hydroxyacetophenone, 1,2-Hexanediol, Glycerin, Dipropylene Glycol, Bisamino PEG/PPG-41/3 Aminoethyl PG-Propyl Dimethicone, Guar Hydroxypropyltrimonium Chloride, Piroctone Olamine, Polyquaternium-10, PEG-12 Dimethicone, Citric Acid, Polyquaternium-7, Mentholum, Menthyl Lactate, Mentha Haplocalyx Oil, Disodium EDTA, Sodium Hydroxide, Butylene Glycol, Trehalose, PEG-150 Distearate, Gardenia Jasminoides Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Triticum Vulgare (Wheat) Germ Oil, Aloe Barbadensis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract."
      ],
      "questions": [
        "Visit www.roycederm.com +1 (307) 461 0958"
      ],
      "package_label_principal_display_panel": [
        "shampoo"
      ],
      "set_id": "46542754-2256-a23c-e063-6394a90a7795",
      "id": "46542754-2257-a23c-e063-6394a90a7795",
      "effective_time": "20251219",
      "version": "1",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "RoyceDerm Tea Tree Therapeutic"
        ],
        "generic_name": [
          "SALICYLIC ACID 3%"
        ],
        "manufacturer_name": [
          "RoyceDerm LLC"
        ],
        "product_ndc": [
          "85424-012"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SALICYLIC ACID"
        ],
        "spl_id": [
          "46542754-2257-a23c-e063-6394a90a7795"
        ],
        "spl_set_id": [
          "46542754-2256-a23c-e063-6394a90a7795"
        ],
        "package_ndc": [
          "85424-012-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "O414PZ4LPZ"
        ]
      }
    }
  ]
}