{
  "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": [
        "AquaSoothe AquaSoothe MINERAL OIL LANOLIN ALCOHOLS DEXPANTHENOL GLYCERIN PETROLATUM PETROLATUM CERESIN"
      ],
      "active_ingredient": [
        "Active ingredient Petrolatum 41%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses • Temporarily protects minor • cuts • scrapes • burns • Temporarily protects and helps relieve chapped or cracked skin and lips • Helps protect skin from the drying effects of wind and cold weather"
      ],
      "warnings": [
        "Warnings For external use only Do not get into eyes Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days or clear up and occur again with a few days Do not use • On deep or puncture wounds • Animal bites • Serious burns Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "stop_use": [
        "Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days or clear up and occur again with a few days"
      ],
      "do_not_use": [
        "Do not use • On deep or puncture wounds • Animal bites • Serious burns"
      ],
      "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."
      ],
      "other_safety_information": [
        "Other information • Store at room temperature 15º - 30ºC (59º - 86ºF)"
      ],
      "dosage_and_administration": [
        "Directions Apply as needed"
      ],
      "inactive_ingredient": [
        "Inactive ingredients ceresin wax, dexpanthenol, glycerin, lanoline alcohol, mineral oil"
      ],
      "questions": [
        "Questions? 1-888-DYNAREX Monday - Friday 9AM - 5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Label 1465 Label 1465_BX_MASTER",
        "Label 1464 Label 1464_IN_MASTER",
        "Label 1463 Label 1463_IN_MASTER"
      ],
      "set_id": "45878c3c-d05d-984c-e063-6294a90a4661",
      "id": "45878c3c-d05e-984c-e063-6294a90a4661",
      "effective_time": "20251209",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "AquaSoothe"
        ],
        "generic_name": [
          "AQUASOOTHE"
        ],
        "manufacturer_name": [
          "Dynarex Corporation"
        ],
        "product_ndc": [
          "67777-555"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PETROLATUM"
        ],
        "rxcui": [
          "725145"
        ],
        "spl_id": [
          "45878c3c-d05e-984c-e063-6294a90a4661"
        ],
        "spl_set_id": [
          "45878c3c-d05d-984c-e063-6294a90a4661"
        ],
        "package_ndc": [
          "67777-555-05",
          "67777-555-06",
          "67777-555-03",
          "67777-555-04",
          "67777-555-01",
          "67777-555-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0616784146522",
          "0616784146416",
          "0616784146317"
        ],
        "unii": [
          "4T6H12BN9U"
        ]
      }
    }
  ]
}