{
  "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": [
    {
      "effective_time": "20170713",
      "inactive_ingredient": [
        "Inactive ingredients aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)"
      ],
      "purpose": [
        "Purpose Vasoconstrictor Astringent"
      ],
      "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."
      ],
      "warnings": [
        "Warnings For external use only Ask a doctor before use if you have heart disease high blood pressure diabetes thyroid disease trouble urinating due to an enlarged 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 do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if bleeding occurs condition gets worse 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 do not put this product into the rectum by using fingers or any mechanical device or applicator"
      ],
      "spl_product_data_elements": [
        "REXALL HEMORRHOIDAL COOLING Phenylephrine Hydrochloride and Witch Hazel ALOE VERA LEAF EDETATE DISODIUM METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE .ALPHA.-TOCOPHEROL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WITCH HAZEL WITCH HAZEL"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have heart disease high blood pressure diabetes thyroid disease trouble urinating due to an enlarged prostate gland"
      ],
      "openfda": {},
      "version": "1",
      "dosage_and_administration": [
        "Directions Adults : when practical, cleanse and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or 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"
      ],
      "stop_use": [
        "Stop use and ask a doctor if bleeding occurs condition gets worse or does not improve within 7 days If pregnant or breast-feeding, ask a health professional before use."
      ],
      "spl_unclassified_section": [
        "Other information store at 20°-25°C (68°-77°F) for lot number and expiration date, see crimp of tube or see box"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel - 26 g Carton Label REXALL HEMORRHOIDAL COOLING GEL NET WT .9 OZ (26 g) label"
      ],
      "indications_and_usage": [
        "Uses temporary relieves irritation and burning helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas"
      ],
      "set_id": "8dd3206b-7b17-41ee-a66f-98f9d3d1ae8f",
      "id": "54358a22-13fd-2b91-e054-00144ff88e88",
      "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."
      ],
      "active_ingredient": [
        "Active Ingredients Phenylephrine Hydrochloride 0.25% Witch Hazel 50%"
      ]
    }
  ]
}