{
  "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": 107
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hemorrhoidal Pain Relief PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PARAFFIN LANOLIN THYME BENZOIC ACID BUTYLATED HYDROXYANISOLE GLYCERIN LANOLIN ALCOHOLS PETROLATUM PETROLATUM MINERAL OIL MINERAL OIL CORN OIL WHITE WAX TOCOPHEROL PROPYLPARABEN WATER"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredients Mineral oil 14% Petrolatum 74.9% Phenylephrine Hydrochloride 0.25%"
      ],
      "purpose": [
        "Active Ingredients Purpose Mineral oil 14% ..................................................................... Protectant Petrolatum 74.9%................................................................. Protectant Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor"
      ],
      "indications_and_usage": [
        "Uses 􀁑􀀃Helps relieve the local itching and discomfort associated with hemorrhoids. 􀁑􀀃Temporarily shrinks hemorrhoidal tissue and relieves burning. 􀁑􀀃Temporarily provides a coating for relief of anorectal discomforts. 􀁑􀀃Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful."
      ],
      "warnings": [
        "Warnings: Warnings: For external and/or intrarectal use only"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have: Ask a doctor before use if you have: 􀁑􀀃Heart disease 􀁑􀀃High blood pressure 􀁑􀀃Thyroid disease 􀁑􀀃Diabetes 􀁑􀀃Difficulty in urination due to enlargement of prostate gland."
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression."
      ],
      "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: Stop use and ask doctor if: 􀁑􀀃Bleeding occurs 􀁑􀀃Condition worsens or does not improve within 7 days 􀁑􀀃Introduction of applicator into the rectum causes additional pain."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)."
      ],
      "dosage_and_administration": [
        "Directions: 􀁑􀀃Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment. 􀁑􀀃When first opening the tube, puncture foil seal with top end of cap apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. 􀁑􀀃Intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum; thoroughly cleanse applicator after each use and replace cover. 􀁑􀀃Also apply ointment to external area. 􀁑􀀃Regular use provides continual therapy for relief of symptoms. 􀁑􀀃Children under 12 years of age: ask a doctor."
      ],
      "storage_and_handling": [
        "Other information: Store at 15°C - 30°C (59°F - 86°F)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients: Benzoic acid, butylated hydroxytoluene, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, propylparaben, paraffin wax, purified water, thymus vulgaris oil, tocopherol acetate, white wax"
      ],
      "safe_handling_warning": [
        "TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING"
      ],
      "other_safety_information": [
        "Important: Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product."
      ],
      "package_label_principal_display_panel": [
        "Hemorrhoidal Ointment"
      ],
      "set_id": "038a2cf5-1b72-227b-e063-6394a90a84ad",
      "id": "2c7264d0-e726-00c1-e063-6394a90af070",
      "effective_time": "20250124",
      "version": "3",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Hemorrhoidal"
        ],
        "generic_name": [
          "PAIN RELIEF"
        ],
        "manufacturer_name": [
          "NeilMed Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "13709-319"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "RECTAL"
        ],
        "substance_name": [
          "MINERAL OIL",
          "PETROLATUM",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1372298"
        ],
        "spl_id": [
          "2c7264d0-e726-00c1-e063-6394a90af070"
        ],
        "spl_set_id": [
          "038a2cf5-1b72-227b-e063-6394a90a84ad"
        ],
        "package_ndc": [
          "13709-319-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "T5L8T28FGP",
          "4T6H12BN9U",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}