{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hydro Gel Glycerin 20% ALOE VERA LEAF METHYLPARABEN PEG-4 OLEATE PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE ALLANTOIN WATER GLYCERIN GLYCERIN SODIUM POLYACRYLATE (2500000 MW) DIAZOLIDINYL UREA PROPYLPARABEN PEG-60 HYDROGENATED CASTOR OIL EDETATE SODIUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information Store at room temperature 15°-30°C (59°-86°F) ** Tamper evident. Do not use if seal is damaged",
        "Distributed By Distributed By Trifecta Pharmaceuticals USA® 101 NE Third Avenue Suite 1500 Fort Lauderdale, FL. 33301 USA www.trifecta-pharma.com"
      ],
      "active_ingredient": [
        "Active Ingredient Glycerin 20%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve minor skin irritation and itching of minor cuts, scrapes and burns Maintains a moist wound environment Ideal for managment of stasis ulcers, pressure ulcers (stages 1-4), first and second degree burns, cuts, post-operative incisions, and skin conditions associated with peristomal care."
      ],
      "stop_use": [
        "Stop use and ask a doctor condition worsens or does not improve within 10-14 days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children If swallowed get medical help or contact Poison Control Center right away"
      ],
      "when_using": [
        "When Using this product Avoid contact with eyes"
      ],
      "dosage_and_administration": [
        "Directions Apply liberally as often as necessary to cover affected areas. If gauze is used as a wound covering, moisten first. Children under 6 months: Consult a doctor before use"
      ],
      "warnings": [
        "Warning For External Use Only"
      ],
      "do_not_use": [
        "DO NOT USE Do not use on Deep pumcture wounds or Animal Bites"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Allantoin, Aloe Vera gel, Diazolidinyl urea, Methylparaben, PEG-4 olivate, PEG-60, hydrogenated castor oil, Propylene glycol, Propylparaben, Purified water, Sodium Polyacrylate, Tetrasodium EDTA, Tocopherol acetate"
      ],
      "questions": [
        "Questions or Comments Call Toll Free 1-888-296-9067"
      ],
      "package_label_principal_display_panel": [
        "4852 GLOBE HYDROGEL 3OZ 062523 CDER"
      ],
      "set_id": "02e8e5d0-7844-39fe-e063-6394a90a57e1",
      "id": "0f4e25fa-bccd-b725-e063-6294a90ac340",
      "effective_time": "20240119",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Hydro Gel"
        ],
        "generic_name": [
          "GLYCERIN 20%"
        ],
        "manufacturer_name": [
          "Trifecta Pharmaceuticals USA LLC"
        ],
        "product_ndc": [
          "69396-127"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "GLYCERIN"
        ],
        "spl_id": [
          "0f4e25fa-bccd-b725-e063-6294a90ac340"
        ],
        "spl_set_id": [
          "02e8e5d0-7844-39fe-e063-6394a90a57e1"
        ],
        "package_ndc": [
          "69396-127-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850026393835"
        ],
        "nui": [
          "N0000185370",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0000728",
          "M0009417"
        ],
        "pharm_class_epc": [
          "Non-Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Glycerol [CS]"
        ],
        "unii": [
          "PDC6A3C0OX"
        ]
      }
    }
  ]
}