{
  "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": [
        "HEMORRHOIDALCREAMPro Phenylephrine HCl, Petrolatum, Mineral Oil POLYOXYL 100 STEARATE PROPYLENE GLYCOL WHITE WAX THYMUS VULGARIS LEAF BENZOIC ACID .ALPHA.-TOCOPHEROL ACETATE MINERAL OIL MINERAL OIL BUTYLATED HYDROXYANISOLE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PETROLATUM PETROLATUM CORN OIL GLYCERIN LANOLIN POLYOXYL 40 HYDROGENATED CASTOR OIL"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Mineral Oil (14% w/w)............................................. Skin Protectant Petrolatum (74.9% w/w)........................................... Skin Protectant Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor"
      ],
      "purpose": [
        "Mineral Oil (14% w/w)............................................. Skin Protectant Petrolatum (74.9% w/w)........................................... Skin Protectant Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor"
      ],
      "indications_and_usage": [
        "Uses Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning) Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders"
      ],
      "warnings": [
        "Warnings For external use only Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days an allergic reaction develops the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase 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."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland"
      ],
      "ask_doctor_or_pharmacist": [
        "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 do not put into the rectum by using fingers or any mechanical device or applicator"
      ],
      "stop_use": [
        "Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days an allergic reaction develops the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase"
      ],
      "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 possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use To use applicator, attach it to the tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly Apply externally to the affected area up to 4 times daily, especially at night, when waking up and after each bowel movement Children under 12 years of age: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information store at 20-25°C (68-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Alpha Tocopherol (Vitamin E), Benzoic Acid, Butylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, PEG-40 Hydrogenated Castor Oil, PEG-100 Stearate, Propylene Glycol, Thymus Vulgaris (Thyme) Flower/Leaf Oil, White Wax"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Principal Display and Drug Fact Panel"
      ],
      "set_id": "e9c32d81-cd9d-4ff2-e053-2995a90aa499",
      "id": "1bbaf306-f8dd-6054-e063-6294a90a57c3",
      "effective_time": "20240625",
      "version": "4",
      "openfda": {}
    }
  ]
}