{
  "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": [
        "Preparation H Cooling Gel phenylephrine hcl, witch hazel ALOE VERA LEAF EDETATE DISODIUM HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WITCH HAZEL WITCH HAZEL"
      ],
      "active_ingredient": [
        "Active ingredients Phenylephrine HCl 0.25% Witch hazel 50.0%"
      ],
      "purpose": [
        "Purposes 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 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 this product 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 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 this product 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"
      ],
      "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 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"
      ],
      "spl_unclassified_section": [
        "Other information store at 20-25°C (68-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E acetate"
      ],
      "questions": [
        "Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374 Additional information Do Not Use if tube seal under cap embossed with “H” is broken or missing. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 For most recent product information, visit www.preparationh.com Trademarks owned or licensed by GSK ©2021 GSK or licensor Made In Canada Do Not Use if tube seal under cap embossed with “H” is broken or missing."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL PREPARATION H HEMORRHOIDAL COOLING GEL Fast Cooling Relief Clear, Non-Greasy Formula with No Unpleasant Scent Prompt, Cooling Relief from Painful Burning & Itching Shrinks Swollen Hemorrhoidal Tissue Relieves External Discomfort 1 TUBE | NET WT 1.8 OZ (51 g) PAA162794 Front Carton PrepH Cooling Gel 1.8 oz (51 g)"
      ],
      "set_id": "cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4",
      "id": "15581b30-e802-550a-e063-6394a90a3aae",
      "effective_time": "20240405",
      "version": "9",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Preparation H Cooling Gel"
        ],
        "generic_name": [
          "PHENYLEPHRINE HCL, WITCH HAZEL"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0573-2840"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PHENYLEPHRINE HYDROCHLORIDE",
          "WITCH HAZEL"
        ],
        "rxcui": [
          "249465"
        ],
        "spl_id": [
          "15581b30-e802-550a-e063-6394a90a3aae"
        ],
        "spl_set_id": [
          "cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4"
        ],
        "package_ndc": [
          "0573-2840-10",
          "0573-2840-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "04JA59TNSJ",
          "101I4J0U34"
        ]
      }
    }
  ]
}