{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Terrasil Balanitis Relief Sulfur, Symphytum Officinale (Comfrey) ALLANTOIN CEDRUS ATLANTICA BARK OIL MEDIUM-CHAIN TRIGLYCERIDES COTTONSEED OIL JOJOBA OIL LAVENDER OIL MAGNESIUM OXIDE SILVER STEARATE WHITE WAX ZINC OXIDE SULFUR SULFUR SYMPHYTUM OFFICINALE WHOLE SYMPHYTUM OFFICINALE WHOLE"
      ],
      "active_ingredient": [
        "Active Ingredient Sulfur 1X HPUS Symphytum Officinale (Comfrey) 1X HPUS"
      ],
      "purpose": [
        "Purpose Sulfur - Rash Relief Symphytum Officinale - Inflammatory Relief"
      ],
      "indications_and_usage": [
        "Uses Helps relieve irritated skin at the head of the penis."
      ],
      "warnings": [
        "Warnings For external use only . When using this product do not use in or near eyes. Stop use and ask a doctor if symptoms last more than 3 days, symptoms worsen, or symptoms clear up and occur again within a few days."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, call Poison Control or seek medical help right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years of age and older: Apply to affected area 2 to 3 times per day or as needed. Children under 2 years of age: Consult a doctor. Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients allantoin, beeswax, cedarwood oil, cottonseed oil, jojoba oil, lavender oil, magnesium oxide, MCT Oil, silver stearate, zinc oxide."
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 14g & 50g Tubes Tube"
      ],
      "set_id": "16c243e0-dec4-4643-949f-48dfd6bc5c08",
      "id": "2763f0a0-abfe-19d4-e063-6394a90a1a7e",
      "effective_time": "20241120",
      "version": "4",
      "openfda": {
        "brand_name": [
          "Terrasil Balanitis Relief"
        ],
        "generic_name": [
          "SULFUR, SYMPHYTUM OFFICINALE (COMFREY)"
        ],
        "manufacturer_name": [
          "Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions"
        ],
        "product_ndc": [
          "24909-119"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SULFUR",
          "SYMPHYTUM OFFICINALE WHOLE"
        ],
        "spl_id": [
          "2763f0a0-abfe-19d4-e063-6394a90a1a7e"
        ],
        "spl_set_id": [
          "16c243e0-dec4-4643-949f-48dfd6bc5c08"
        ],
        "package_ndc": [
          "24909-119-14",
          "24909-119-44",
          "24909-119-15",
          "24909-119-50",
          "24909-119-28"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "70FD1KFU70",
          "H8FJJ6KX5Y"
        ]
      }
    }
  ]
}