{
  "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": "2026-07-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hemorrhoid, Fissure, ProctalgiaSuppositories Carbon, Mirabilite, Peppermint oil, Borneol PEPPERMINT OIL PEPPERMINT POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 60 GLYCERIN GLYCERIN ACTIVATED CHARCOAL ACTIVATED CHARCOAL SODIUM SULFATE SODIUM SULFATE ANHYDROUS BORNEOL BORNEOL"
      ],
      "active_ingredient": [
        "Carbon 1% Mirabilite 2% Peppermint oil 0.2% Borneol 3% Glycerin 8%"
      ],
      "purpose": [
        "Adsorbent and detoxifying Anti-inflammatory and soothing Cooling and analgesic Analgesic and anti-inflammatery Humectant and moisturizing"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach ofchildren. lf swallowed, seek medicalhelp or contact a PolsonControl Center right away."
      ],
      "indications_and_usage": [
        "temporarily protects the inflamed, irritatedanorectal surface to help make bowel movementsless painful from irritation and abrasion duringbowel movement *provides temporary relief of pain, soreness, orburning*helps relieve the local or anorectal itching anddiscomfort associated with hemorrhoids"
      ],
      "warnings": [
        "For external and/or intrarectal use."
      ],
      "dosage_and_administration": [
        "adults and children 12 years of age and over:when practical, cleanse area with mild soap andwarm water and rinse thoroughly.Gently dry bypatting or blotting with toilet tissue or a soft clothbefore applying.Apply to the affected area up to 4 times daily,especially at night, in the morning or after eachbowel movement.For intrarectal use: after wetting, apply around theanal area and then insert into the rectum..children under 12 years of age: ask a doctor"
      ],
      "storage_and_handling": [
        "Additionalinformation:store in a cool, dry place.It is recommended tostore below 68°F(20°C)Refrigeration is advised."
      ],
      "inactive_ingredient": [
        "Polyethylene Glycol POLYSORBATE 60"
      ],
      "package_label_principal_display_panel": [
        "label"
      ],
      "set_id": "1d40d16a-ee52-463a-e063-6394a90a6077",
      "id": "486510a7-f140-3a89-e063-6294a90a7bf7",
      "effective_time": "20260114",
      "version": "4",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Hemorrhoid, Fissure, ProctalgiaSuppositories"
        ],
        "generic_name": [
          "CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL"
        ],
        "manufacturer_name": [
          "WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd."
        ],
        "product_ndc": [
          "84533-001"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ACTIVATED CHARCOAL",
          "BORNEOL",
          "GLYCERIN",
          "PEPPERMINT OIL",
          "SODIUM SULFATE"
        ],
        "spl_id": [
          "486510a7-f140-3a89-e063-6294a90a7bf7"
        ],
        "spl_set_id": [
          "1d40d16a-ee52-463a-e063-6394a90a6077"
        ],
        "package_ndc": [
          "84533-001-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185370",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0000728",
          "M0009417"
        ],
        "pharm_class_epc": [
          "Non-Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Glycerol [CS]"
        ],
        "unii": [
          "2P3VWU3H10",
          "M89NIB437X",
          "PDC6A3C0OX",
          "AV092KU4JH",
          "0YPR65R21J"
        ]
      }
    }
  ]
}