{
  "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": "2026-10-29",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Rugby Anti-Dandruff Selenium Sulfide Selenium Sulfide Selenium Sulfide Water Ammonium Laureth-2 Sulfate Ammonium Lauryl Sulfate COCO MONOETHANOLAMIDE Cocamidopropyl Betaine Coco Diethanolamide Magnesium Aluminum Silicate HYPROMELLOSE, UNSPECIFIED Menthol, unspecified form Chlorphenesin Phenoxyethanol DMDM Hydantoin Citric Acid Monohydrate Sodium Chloride Fd&C Blue No. 1 D&C Red No. 33"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: Rugby Laboratories 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152"
      ],
      "active_ingredient": [
        "Active ingredient Selenium Sulfide 1%"
      ],
      "purpose": [
        "Purpose Anti-seborrheic dermatitis, anti-dandruff"
      ],
      "indications_and_usage": [
        "Uses for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent their recurrence."
      ],
      "warnings": [
        "Warnings For external use only As a doctor before use if condition covers a large area of the body. When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. for color-treated or permed hair, rinse thoroughly. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "ask_doctor": [
        "As a doctor before use if condition covers a large area of the body."
      ],
      "when_using": [
        "When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. for color-treated or permed hair, rinse thoroughly."
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or does not improve after regular use of this 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 shake well shampoo, then rinse thoroughly for best results, use at least twice a week or as directed by a doctor."
      ],
      "storage_and_handling": [
        "Other information store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, cocamidopropyl betaine, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, chlorphenesin, phenoxyethanol, citric acid, sodium chloride, blue 1, red 33"
      ],
      "questions": [
        "Questions or comments? 1-866-645-2158"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label COMPARE TO ACTIVE INGREDIENT IN SELSUN BLUE ® * Rugby ® NDC 0536-1995-53 New Formula ANTI • DANDRUFF SHAMPOO Selenium Sulfide 1% BLUE FORMULA FOR NORMAL HAIR Helps to control dandruff symptoms Leaves hair soft and manageable 7 fl oz (207 mL) 05-2675A PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label"
      ],
      "set_id": "f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2",
      "id": "50c4b8c0-9787-407e-9fa6-d6a03ea4323e",
      "effective_time": "20240314",
      "version": "6",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Rugby Anti-Dandruff"
        ],
        "generic_name": [
          "SELENIUM SULFIDE"
        ],
        "manufacturer_name": [
          "Rugby Laboratories"
        ],
        "product_ndc": [
          "0536-1995"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SELENIUM SULFIDE"
        ],
        "rxcui": [
          "204642"
        ],
        "spl_id": [
          "50c4b8c0-9787-407e-9fa6-d6a03ea4323e"
        ],
        "spl_set_id": [
          "f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2"
        ],
        "package_ndc": [
          "0536-1995-53"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "Z69D9E381Q"
        ]
      }
    }
  ]
}