{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "RoyceDerm Rosacea Treatment Cream. Sulphur 1X HPUS(10%) SULFUR SULFUR CETEARYL ALCOHOL TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 ETHYLHEXYL PALMITATE DIMETHICONE 1,2-HEXANEDIOL LYSOPHOSPHATIDYLCHOLINE, SOYBEAN CAMELLIA SINENSIS LEAF HYDROXYACETOPHENONE PENTYLENE GLYCOL HYALURONATE SODIUM PROPYLENE GLYCOL ISOHEXADECANE PANTHENOL SODIUM ACETYLATED HYALURONATE SODIUM STEAROYL GLUTAMATE CERAMIDE NP HYDROXYPROPYL BETADEX ACACIA SENEGAL GUM BETAINE SALICYLATE ETHYLHEXYLGLYCERIN AZELAIC ACID DISODIUM PHOSPHATE XANTHAN GUM NIACINAMIDE AQUA CAPRYLIC/CAPRIC TRIGLYCERIDE ALLANTOIN CETEARYL GLUCOSIDE PEG-100 STEARATE CENTELLA ASIATICA TRITERPENOIDS CHLORPHENESIN GLYCERIN BUTYLENE GLYCOL POLYACRYLATE CROSSPOLYMER-6 CETEARETH-25 MALTODEXTRIN PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER GLYCERYL STEARATE POTASSIUM CETYL PHOSPHATE PHENOXYETHANOL ALOE VERA WHOLE"
      ],
      "active_ingredient": [
        "Sulphur 1X HPUS*(10%)"
      ],
      "purpose": [
        "Rosacea/acne treatment"
      ],
      "dosage_and_administration": [
        "Protects and helps relieve red, irritated, or sensitive skin Reduce visible dryness and discomfort Helps improve the lookuneven skin tone"
      ],
      "warnings": [
        "For external use only conduct a patch test on a small area of skin, such as in front of the ear or under the jawline. Avoid contact with eyes. lf contact occurs, rinse thoroughly with water. On damaged or wounded skin large areasof skin condition worsens or persists for more than 7 days ask a health professional before In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)"
      ],
      "when_using": [
        "conduct a patch test on a small area of skin, such as in front of the ear or under the jawline. Avoid contact with eyes. lf contact occurs, rinse thoroughly with water."
      ],
      "do_not_use": [
        "On damaged or wounded skin large areasof skin"
      ],
      "ask_doctor": [
        "condition worsens or persists for more than 7 days"
      ],
      "pregnancy_or_breast_feeding": [
        "ask a health professional before"
      ],
      "keep_out_of_reach_of_children": [
        "In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)"
      ],
      "indications_and_usage": [
        "Cleanse and dry skin. Apply a thin layer toaffected areas. Use thrice daily or as directed by a doctor."
      ],
      "other_safety_information": [
        "store at room temperature."
      ],
      "inactive_ingredient": [
        "Aqua, Propylene Glycol, Cetearyl Alcohol,Niacinamide, lsohexadecane, Ethylhexyl Palmitate, Azelaic Acid, Caprylic/Capric Triglyceride, Hydroxypropyl Cyclodextrin, Dimethicone, Disodium Phosphate, Glyceryl Stearate, Panthenol, Polyacrylate Crosspolymer-6, Ceteareth-25, Potassium Cetyl Phosphate, Allantoin, Cetearyl Glucoside.PEG-100 Stearate, Phenoxyethanol, Methyl Cyclodextrin, 1,2-Hexanediol,Centella Asiatica Extract, Chlorphenesin, Xanthan Gum, Aloe Barbadensis Extract, Camellia Sinensis Leaf Extract, Glycerin, Acacia Senegal Gum,Maltodextrin, Butylene Glycol, Pentylene Glycol, Betaine Salicylate,Sodium Hyaluronate, Sodium Acetylated Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxyacetophenone, Hydrolyzed Sodium Hyaluronate, Phosphatidylcholine, Ethylhexylglycerin,Ceramide NP, Beta-Glucan, Sodium Stearoyl Glutamate"
      ],
      "questions": [
        "Email service@roycederm.com"
      ],
      "package_label_principal_display_panel": [
        "package"
      ],
      "set_id": "3df717fc-cf2f-8a9a-e063-6394a90ae4e2",
      "id": "3df717fc-cf30-8a9a-e063-6394a90ae4e2",
      "effective_time": "20250904",
      "version": "1",
      "openfda": {
        "application_number": [
          "M006"
        ],
        "brand_name": [
          "RoyceDerm Rosacea Treatment Cream."
        ],
        "generic_name": [
          "SULPHUR 1X HPUS(10%)"
        ],
        "manufacturer_name": [
          "RoyceDerm LLC"
        ],
        "product_ndc": [
          "85424-009"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SULFUR"
        ],
        "spl_id": [
          "3df717fc-cf30-8a9a-e063-6394a90ae4e2"
        ],
        "spl_set_id": [
          "3df717fc-cf2f-8a9a-e063-6394a90ae4e2"
        ],
        "package_ndc": [
          "85424-009-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850068161560"
        ],
        "unii": [
          "70FD1KFU70"
        ]
      }
    }
  ]
}