{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Prosoria Medicated Selenium Sulfide Selenium Sulfide Selenium Sulfide Water Cetyl alcohol GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) Aloe Vera Leaf Butylated Hydroxytoluene Cocamidopropyl Betaine D&C Yellow No. 10 Edetate Disodium Anhydrous FD&C Red No. 40 Panthenol Propylene Glycol Stearyl Alcohol .ALPHA.-TOCOPHEROL ACETATE Xanthan Gum Sodium Laureth-3 Sulfate Phenoxyethanol"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by Nuvothera, Inc. Fort Worth, Texas 76104"
      ],
      "active_ingredient": [
        "Active ingredient Selenium sulfide 1%"
      ],
      "purpose": [
        "Purpose Anti-dandruff, Anti-seborrheic dermatitis"
      ],
      "indications_and_usage": [
        "Uses for the relief of itching, irritation, redness, flaking, scaling associated with dandruff and seborrheic dermatitis."
      ],
      "warnings": [
        "Warnings For external use only When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. if condition worsens or does not improve after regular use of this product as directed, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. if condition worsens or does not improve after regular use of this product as directed, consult a doctor."
      ],
      "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 for best results use at least twice a week or as directed by a doctor. for maximum control, use every time you shampoo. shake bottle before use. wet hair, massage onto scalp, rinse, repeat if desired."
      ],
      "storage_and_handling": [
        "Other information store at room temperature 59-77°F (15-25°C)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aloe Barbadensis Leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, D&C YELLOW 10, FD&C RED 40, Guar Hydroxypropyltrimonium Chloride, Panthenol, Phenoxyethanol, Propylene Glycol, Water, Sodium Laureth Sulfate, Stearyl Alcohol, Tocopheryl Acetate, Xanthan Gum."
      ],
      "questions": [
        "Questions? Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label treats prosoriä medicated shampoo selenium sulfide 1% anti-dandruff anti-seborrheic 6 FL OZ (177 mL) Principal Display Panel - 177 mL Bottle Label"
      ],
      "set_id": "44eaaeb0-1400-4697-85d0-e8c2282c1cba",
      "id": "6fec05aa-5d44-4667-98f7-c61ac09c6307",
      "effective_time": "20240111",
      "version": "2",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Prosoria Medicated"
        ],
        "generic_name": [
          "SELENIUM SULFIDE"
        ],
        "manufacturer_name": [
          "Nuvothera, Inc."
        ],
        "product_ndc": [
          "71573-121"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SELENIUM SULFIDE"
        ],
        "rxcui": [
          "204642"
        ],
        "spl_id": [
          "6fec05aa-5d44-4667-98f7-c61ac09c6307"
        ],
        "spl_set_id": [
          "44eaaeb0-1400-4697-85d0-e8c2282c1cba"
        ],
        "package_ndc": [
          "71573-121-12"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "Z69D9E381Q"
        ]
      }
    }
  ]
}