{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Drs. pharmacy HEMORRHOIDAL COOLING phenylephrine HCL, witch hazel PROPYLENE GLYCOL SODIUM CITRATE, UNSPECIFIED FORM METHYLPARABEN EDETATE DISODIUM PROPYLPARABEN SODIUM METABISULFITE HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WITCH HAZEL WITCH HAZEL"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Phenylephrine HCI, 0.25% Witch Hazel, 50.0%"
      ],
      "purpose": [
        "PURPOSE Vasoconstrictor Astringent"
      ],
      "indications_and_usage": [
        "USES helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas"
      ],
      "warnings": [
        "WARNINGS For external use only"
      ],
      "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 this product into the rectum by using fingers or any mechanical device or applicator"
      ],
      "stop_use": [
        "STOP USING AND ASK YOUR DOCTOR IF bleeding occurs condition worsens or does not improve within 7 days"
      ],
      "pregnancy_or_breast_feeding": [
        "IF PREGNENT 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 wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel. when first opening the tube, puncture foil seal with top end of cap apply externally to the affected area up to 4 times daily, especially at night, in the morning or 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 edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite"
      ],
      "questions": [
        "QUESTIONS www.drspharmacyusa.com"
      ],
      "package_label_principal_display_panel": [
        "hemorroidal cooling gel"
      ],
      "set_id": "d6f6b482-d85d-001c-e053-2995a90ad98c",
      "id": "2b521bcb-3d08-f590-e063-6294a90a36c0",
      "effective_time": "20250109",
      "version": "8",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Drs. pharmacy HEMORRHOIDAL COOLING"
        ],
        "generic_name": [
          "PHENYLEPHRINE HCL, WITCH HAZEL"
        ],
        "manufacturer_name": [
          "OL PHARMA TECH, LLC Drs PHARMACY"
        ],
        "product_ndc": [
          "80489-959"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PHENYLEPHRINE HYDROCHLORIDE",
          "WITCH HAZEL"
        ],
        "spl_id": [
          "2b521bcb-3d08-f590-e063-6294a90a36c0"
        ],
        "spl_set_id": [
          "d6f6b482-d85d-001c-e053-2995a90ad98c"
        ],
        "package_ndc": [
          "80489-959-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "04JA59TNSJ",
          "101I4J0U34"
        ]
      }
    }
  ]
}