{
  "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,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "RoyceDerm Sulfur Soap. Sulfur WATER OLEA EUROPAEA (OLIVE) FRUIT OIL STYPHNOLOBIUM JAPONICUM FLOWER BUD ALOE SORBITOL LAURIC ACID ELAEIS GUINEENSIS (PALM) OIL COCOS NUCIFERA (COCONUT) OIL STEARIC ACID GLYCERIN SALICYLIC ACID SULFUR SULFUR COLEUS FORSKOHLII ROOT OIL POTASSIUM COCOATE LANOLIN ASIAN GINSENG TEA TREE OIL"
      ],
      "active_ingredient": [
        "Sulfur 10.0%"
      ],
      "purpose": [
        "Acne Treatment"
      ],
      "when_using": [
        "For the treatment of acne."
      ],
      "dosage_and_administration": [
        "Create a rich lather with the mesh bag, gently apply to affected areas, leaving it on the skin for 3 to 5 minutes. Rinse thoroughly with waterand pat dry with a clean towel. Incorporate into your routine 1 to 3 times a day, or as directed by a doctor, for optimal results."
      ],
      "other_safety_information": [
        "Store at room temperature and out of direct sunlight"
      ],
      "questions": [
        "Visit www.roycederm.com"
      ],
      "warnings": [
        "For external use only. Apply solely to acne-affected areas.Use caution when combining with other topical acne medications to prevent skin irritation and dryness. Avoid use on broken or large skin areas. Discontinue use and consult a doctor ifexcessive skin irritation occurs. When using this product avoid contact with eyes. lf contact occurs, rinse the eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regula ruse as directed. lf swallowed, get medical help or contact a Poison Control center(1-800-222-1222) right away."
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or does not improve after regula ruse as directed."
      ],
      "keep_out_of_reach_of_children": [
        "lf swallowed, get medical help or contact a Poison Control center(1-800-222-1222) right away."
      ],
      "inactive_ingredient": [
        "Water, Olea Europaea Fruit Oil, 0,25% Salicylic Acid, Lauric Acid, Stearic Acid,Sorbitol,Glycerin, Cocos Nucifera Oil, Elaeis Guineensis Oil, Botanical Acaricide.Potassium Cocoate, Lanolin, Sophor ajaponica Extract, Aloe Extract, Sulfur Spring Extract, Ginseng, Coleus Forskohlii Root Oil, Tea Tree Essential Oil."
      ],
      "indications_and_usage": [
        "Uses for the treatment of acne"
      ],
      "package_label_principal_display_panel": [
        "Soap"
      ],
      "set_id": "3a323a77-eff4-973f-e063-6394a90a02a0",
      "id": "3a323a77-eff5-973f-e063-6394a90a02a0",
      "effective_time": "20250718",
      "version": "1",
      "openfda": {
        "application_number": [
          "M006"
        ],
        "brand_name": [
          "RoyceDerm Sulfur Soap."
        ],
        "generic_name": [
          "SULFUR"
        ],
        "manufacturer_name": [
          "RoyceDerm LLC"
        ],
        "product_ndc": [
          "85424-003"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SULFUR"
        ],
        "rxcui": [
          "1053330"
        ],
        "spl_id": [
          "3a323a77-eff5-973f-e063-6394a90a02a0"
        ],
        "spl_set_id": [
          "3a323a77-eff4-973f-e063-6394a90a02a0"
        ],
        "package_ndc": [
          "85424-003-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "70FD1KFU70"
        ]
      }
    }
  ]
}