{
  "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": [
        "Cooling Gel Pain Relief Cooling Gel HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) METHYLPARABEN POLYSORBATE 80 SULISOBENZONE ALPHA-TOCOPHEROL ACETATE WITCH HAZEL WITCH HAZEL EDETATE DISODIUM PROPYLENE GLYCOL SODIUM CITRATE PROPYLPARABEN WATER ALOE BARBADENSIS LEAF PHENYLEPHRINE PHENYLEPHRINE"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredients Phenylephrine HCl 0.25% Witch Hazel 50%"
      ],
      "purpose": [
        "Purpose Phenylephrine HCl 0.25% .......................................................................Vasoconstrictor Witch Hazel 50%. ............................................................................................Astringent"
      ],
      "indications_and_usage": [
        "Uses • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoidal tissue • provides temporary relief from irritation and burning • temporarily provides a cooling coating for relief of anorectal discomforts"
      ],
      "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 prostate gland unless directed by a doctor"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breastfeeding, ask a health professional before use."
      ],
      "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 in the rectum by using fi ngers or any mechanical device or applicator in case of bleeding, consult a doctor promptly."
      ],
      "stop_use": [
        "Stop use and ask a doctor if Bleeding occurs Condition worsens or does not improve within 7 days."
      ],
      "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 cream When fi rst opening the tube, puncture foil seal with top end of cap Apply externally to the affected area up to 4 times daily Children under 12 years of age: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information: Storage temperature: not to exceed 30°C (86°F). Protect from freezing."
      ],
      "inactive_ingredient": [
        "Inactive ingredients: Aloe Barbadensis Leaf Extract, Edetate Disodium, Hydroxyethyl Cellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purifi ed Water, Sodium Citrate, Sulisobenzone, Vitamin E Acetate."
      ],
      "questions": [
        "Questions or comments? 1 (877) 477-8633"
      ],
      "other_safety_information": [
        "TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING."
      ],
      "safe_handling_warning": [
        "Important: Please do not discard this printed box and any enclosed printed material. The inside fi nal product may not have all the details you require for the ongoing use of the product."
      ],
      "package_label_principal_display_panel": [
        "Package Label Tube Box"
      ],
      "set_id": "49fb637b-ecc5-1f9b-e063-6294a90ab41a",
      "id": "49fb637b-ecc6-1f9b-e063-6294a90ab41a",
      "effective_time": "20260204",
      "version": "1",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Cooling Gel"
        ],
        "generic_name": [
          "PAIN RELIEF COOLING GEL"
        ],
        "manufacturer_name": [
          "NeilMed Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "13709-354"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "WITCH HAZEL",
          "PHENYLEPHRINE"
        ],
        "rxcui": [
          "249465"
        ],
        "spl_id": [
          "49fb637b-ecc6-1f9b-e063-6294a90ab41a"
        ],
        "spl_set_id": [
          "49fb637b-ecc5-1f9b-e063-6294a90ab41a"
        ],
        "package_ndc": [
          "13709-354-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0705928150072"
        ],
        "nui": [
          "N0000186105",
          "N0000009917"
        ],
        "pharm_class_epc": [
          "alpha-1 Adrenergic Agonist [EPC]"
        ],
        "pharm_class_moa": [
          "Adrenergic alpha1-Agonists [MoA]"
        ],
        "unii": [
          "101I4J0U34",
          "1WS297W6MV"
        ]
      }
    }
  ]
}