{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Dermatology Psoriasis Cream COAL TAR COAL TAR COAL TAR ALKYL (C12-15) BENZOATE ALOE BARBADENSIS LEAF JUICE ARCTIUM LAPPA ROOT CAPRYLYL GLYCOL Carthamus Tinctorius (Safflower) Seed Oil CETYL ALCOHOL CHAMOMILE DIMETHICONE CETYL ESTERS WAX ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL STEARATE Hexylene Glycol HYDROCORTISONE HYDROGENATED POLYDECENE (1500 CST) LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF PEG-100 PHENOXYETHANOL PROPYLENE GLYCOL WATER SODIUM POLYACRYLATE (2500000 MW) TRIDECETH-6 Xanthan Gum"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredient 2.5% Coal Tar Solution USP (0.5% Coal Tar)"
      ],
      "purpose": [
        "Purpose .............. Psoriasis"
      ],
      "indications_and_usage": [
        "Uses ■ helps prevent the recurrence and relief of symptoms associated with psoriasis including itching, scaling, flaking, redness, and irritation of the skin"
      ],
      "warnings": [
        "Warnings For external use only Do not use unless directed by a doctor ■ for prolonged periods ■ if condition covers a large area of the body ■ in or around the rectum or in the genital area or groin ■ with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs When using this product ■ use caution in exposing skin to sunlight after applying product. It may increase your tendency to sunburn for up to 24 hours after application ■ avoid contact with eyes. If contact occurs, rinse thoroughly with water ■ talk with your physician before you use any other medicines or cleansers on your skin Stop use and ask a doctor if symptoms do not improve or if they worsen after regular use of this product"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away"
      ],
      "other_safety_information": [
        "WARNING: This product can expose you to chemicals including Coal Tar, which is known to the state of California to cause cancer. For more information go to www.P65Warnings.ca.gov",
        "Other Information store in a dry area at 15º-30ºC (59º-86ºF)"
      ],
      "dosage_and_administration": [
        "Directions ■ Apply to affected area 1 to 4 times daily or as directed by a doctor ■ children under 2 years: ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Alkyl (C12-15) Benzoate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Arctium Lappa (Burdock) Root Extract, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Flower Extract, Dimethicone, Emulsifying Wax, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Hydrocortisone, Hydrogenated Polydecene, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf, PEG-100, Phenoxyethanol, Propylene Glycol, Purified Water, Sodium Polyacrylate, Trideceth-6, Xanthan Gum"
      ],
      "package_label_principal_display_panel": [
        "G.M.J. Natural Products Labeling ---------------------------------------------- G.M.J. Natural Products DERMATOLOGY PSORIASIS CREAM Is formulated specifically to address the many symptoms of psoriasis, utilizing specially selected ingredients for maximum benefit. 4 oz (113 g) Distributed by: GMJ Natural Products 431 S Acacia Ave. Fullerton, CA 92831 (714) 254-0682 gmjnatural@yahoo.com www.gmjnaturals.com Box Bottle res Psoriasis Box Psoriasis Jar"
      ],
      "set_id": "96cc5455-f3b8-4ded-a158-5de209d7bf0d",
      "id": "c8b79a52-a29b-4e02-afe3-f1f53d29cbef",
      "effective_time": "20260821",
      "version": "1",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Dermatology Psoriasis Cream"
        ],
        "generic_name": [
          "COAL TAR"
        ],
        "manufacturer_name": [
          "G.M.J Natural Products, Inc."
        ],
        "product_ndc": [
          "87921-111"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "COAL TAR"
        ],
        "rxcui": [
          "283109"
        ],
        "spl_id": [
          "c8b79a52-a29b-4e02-afe3-f1f53d29cbef"
        ],
        "spl_set_id": [
          "96cc5455-f3b8-4ded-a158-5de209d7bf0d"
        ],
        "package_ndc": [
          "87921-111-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R533ESO2EC"
        ]
      }
    }
  ]
}