{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Calmoseptine anorectal ointment FERRIC OXIDE RED CHLOROTHYMOL GLYCERIN PHENOL SODIUM BICARBONATE THYMOL LANOLIN LANOLIN MENTHOL MENTHOL PETROLATUM PETROLATUM ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active Ingredients Lanolin 15.7% Menthol 0.44% Petrolatum 24% Zinc Oxide 20.6% Purpose Active Ingredients Purpose Lanolin 15.7%...........................Anorectal Protectant Menthol 0.44%...........................Anorectal Analgesic Petrolatum 24%........................Anorectal Protectant Zinc Oxide 20.6%......Anorectal Protectant, Astringent"
      ],
      "purpose": [
        "Purpose Active Ingredients Purpose Lanolin 15.7%...........................Anorectal Protectant Menthol 0.44%...........................Anorectal Analgesic Petrolatum 24%........................Anorectal Protectant Zinc Oxide 20.6%......Anorectal Protectant, Astringent"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects irritated areas. For the temporary relief of: local itching and discomfort in the perianal area pain or burning skin irritations"
      ],
      "warnings": [
        "Warnings For external use only When using this product * Certain persons can develop allergic reactions to ingredients in this product. * Do not put this product into the rectum by using fingers or any mechanical device or applicator. * Do not exceed the recommended daily dosage unless directed by a doctor. * Avoid contact with eyes."
      ],
      "when_using": [
        "When using this product * Certain persons can develop allergic reactions to ingredients in this product. * Do not put this product into the rectum by using fingers or any mechanical device or applicator. * Do not exceed the recommended daily dosage unless directed by a doctor. * Avoid contact with eyes."
      ],
      "ask_doctor": [
        "Stop use and ask doctor if condition worsens or does not improve within 7 days bleeding occurs symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth or air dry before application of this product. Apply externally to the affected area up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: calamine, chlorothymol, glycerin, phenol, sodium bicarbonate, and thymol in a suitable ointment base"
      ],
      "package_label_principal_display_panel": [
        "Calmoseptine Ointment Calmoseptine"
      ],
      "set_id": "ff9539ed-d9ae-401d-adbc-df8f1d751431",
      "id": "2ba19ed3-445d-e95a-e063-6394a90abb3f",
      "effective_time": "20250113",
      "version": "14",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Calmoseptine"
        ],
        "generic_name": [
          "ANORECTAL OINTMENT"
        ],
        "manufacturer_name": [
          "Calmoseptine Inc."
        ],
        "product_ndc": [
          "0799-0001"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LANOLIN",
          "MENTHOL",
          "PETROLATUM",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1946476",
          "1946481"
        ],
        "spl_id": [
          "2ba19ed3-445d-e95a-e063-6394a90abb3f"
        ],
        "spl_set_id": [
          "ff9539ed-d9ae-401d-adbc-df8f1d751431"
        ],
        "package_ndc": [
          "0799-0001-02",
          "0799-0001-03",
          "0799-0001-04",
          "0799-0001-05",
          "0799-0001-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0746876000460"
        ],
        "unii": [
          "7EV65EAW6H",
          "L7T10EIP3A",
          "4T6H12BN9U",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}