{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Durma DynaGel Durma DynaGel DIAZOLIDINYL UREA EDETATE SODIUM GLYCERIN GLYCERIN METHYLPARABEN POLYOXYL 60 HYDROGENATED CASTOR OIL PROPYLPARABEN WATER ALPHA-TOCOPHEROL ACETATE ALOE VERA LEAF ALLANTOIN SODIUM POLYACRYLATE (8000 MW) PROPYLENE GLYCOL"
      ],
      "active_ingredient": [
        "Active Ingredient Glycerin 20%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Use(s) • Temporarily protects and helps relieve minor skin irritation and itching of minor cute, scrapes, and burns • Maintains a moist wound environment • Ideal for management of stasis ulcers, pressure ulcers (stage 1-4), first second-degree burns, cuts, post-operative incicions, and skin conditions associated with peristomal care"
      ],
      "warnings": [
        "Warnings For External Use Only Do not use on • deep or puncture wounds • Animal bites When using this product • Avoid contact with eyes. Stop use and ask a doctor if • Condition worsens or does not improve withing 10-14 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use on • deep or puncture wounds • Animal bites"
      ],
      "when_using": [
        "When using this product • Avoid contact with eyes."
      ],
      "stop_use": [
        "Stop use and ask a doctor if • Condition worsens or does not improve withing 10-14 days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "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."
      ],
      "other_safety_information": [
        "Other Information • Store at room temperature 15° - 30ºC (59° - 86°F) • Tamper evident. Do not use if seal is damaged."
      ],
      "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? • 1-888-DYNAREX Monday - Friday, 9AM - 5PM EST."
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "Label 1280 Durma DynaGel 1280_IN_MASTER"
      ],
      "set_id": "3bcbe314-98ca-78f1-e063-6394a90a13ad",
      "id": "3bcbe314-98cb-78f1-e063-6394a90a13ad",
      "effective_time": "20250807",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Durma DynaGel"
        ],
        "generic_name": [
          "DURMA DYNAGEL"
        ],
        "manufacturer_name": [
          "Dynarex Corporation"
        ],
        "product_ndc": [
          "67777-236"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "GLYCERIN"
        ],
        "rxcui": [
          "2637866"
        ],
        "spl_id": [
          "3bcbe314-98cb-78f1-e063-6394a90a13ad"
        ],
        "spl_set_id": [
          "3bcbe314-98ca-78f1-e063-6394a90a13ad"
        ],
        "package_ndc": [
          "67777-236-01",
          "67777-236-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0616784128016"
        ],
        "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"
        ]
      }
    }
  ]
}