{
  "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": [
        "Calmol 4 Zinc Oxide and Cocoa Butter GLYCERYL MONOSTEARATE FAT, HARD METHYLPARABEN PROPYLPARABEN ZINC OXIDE ZINC OXIDE COCOA BUTTER COCOA BUTTER BISMUTH SUBGALLATE"
      ],
      "active_ingredient": [
        "Active Ingredients (in each suppository) Cocoa Butter 76% Zinc Oxide 10%"
      ],
      "purpose": [
        "Purpose Protectant Astringent"
      ],
      "indications_and_usage": [
        "Uses gives temporary relief of burning, irritation, itching and discomfort associated with hemorrhoids temporarily provides a coating for for anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful"
      ],
      "warnings": [
        "Warnings For rectal use only When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask doctor if bleeding occurs or if condition worsens or does not improve within 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product do not exceed the recommended daily dosage unless directed by a doctor"
      ],
      "stop_use": [
        "Stop use and ask doctor if bleeding occurs or if condition worsens or does not improve within 7 days"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product detach one suppository from the strip; remove wrapper before inserting into rectum as follows: slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppository insert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movement children under 12 years of age, consult a doctor"
      ],
      "other_safety_information": [
        "Other information store in a cool place not ober 80°F to avoid melting if subjected to higher temperatures, refrigeration may restore to a usable condition"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Bismuth subgallate, glyceryl stearate, hydrogenated vegetable oil, methylparaben, propylparaben"
      ],
      "questions": [
        "Questions or comments? Call toll-free 1-800-204-6434 weekdays 9 AM to 5 PM EST"
      ],
      "package_label_principal_display_panel": [
        "Calmol 4 Suppository 24 count CALMOL 24ct_R0625.p1.pdf Calmol 4 Hemorrhoidal Suppository 24 count Distributed by: Resical Inc. Orchard Park, New York 14127 The image below depicts a representative sample of packaging that is available. CALMOL 24CT_R0625.p1.jpg"
      ],
      "set_id": "5516f800-d3fa-4b90-a3eb-c0bdf3183b9b",
      "id": "41eb9348-e861-4ac7-e063-6294a90a96cf",
      "effective_time": "20251024",
      "version": "12",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Calmol 4"
        ],
        "generic_name": [
          "ZINC OXIDE AND COCOA BUTTER"
        ],
        "manufacturer_name": [
          "Resical Inc."
        ],
        "product_ndc": [
          "67492-104"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "RECTAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "COCOA BUTTER"
        ],
        "rxcui": [
          "1049137",
          "1113714"
        ],
        "spl_id": [
          "41eb9348-e861-4ac7-e063-6294a90a96cf"
        ],
        "spl_set_id": [
          "5516f800-d3fa-4b90-a3eb-c0bdf3183b9b"
        ],
        "package_ndc": [
          "67492-104-11",
          "67492-104-12",
          "67492-104-13"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "512OYT1CRR"
        ]
      }
    }
  ]
}