{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Dr. Butler Soothing Incontinence Petrolatum 36% PPG-15 STEARYL ETHER ALOE 4-TERT-BUTYLCYCLOHEXANOL PENTYLENE GLYCOL CHAMOMILE SUNFLOWER OIL POLYSORBATE 80 WATER MINERAL OIL MINERAL OIL PETROLATUM"
      ],
      "active_ingredient": [
        "Petrolatum 36%"
      ],
      "purpose": [
        "Skin Protectant"
      ],
      "indications_and_usage": [
        "Temporarily protects and helps relieve chafed, chapped, or cracked skin."
      ],
      "warnings": [
        "For external use only. Do not use on deep or puncture wounds. When using this product avoid contact in eyes, rinse with water to remove, contents under pressure, do not puncture or incinerate, do not store at temperatures above 120F. Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Ask a healthcare or professional before use."
      ],
      "pregnancy_or_breast_feeding": [
        "Ask a healthcare or professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "If swallowed, seek medical help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Shake well. Hold 4-6 inches from the skin and apply a thin continuous coating. Apply as needed."
      ],
      "inactive_ingredient": [
        "4-t-Butylcyclohexanol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, Mineral Oil, Pentylene Glycol, PPG-15 Stearyl Ether."
      ],
      "package_label_principal_display_panel": [
        "Label Label"
      ],
      "set_id": "d17a0c28-a5b7-4df0-e053-2995a90a8edd",
      "id": "2958cebe-650d-ea65-e063-6394a90a3f39",
      "effective_time": "20241215",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Dr. Butler Soothing Incontinence"
        ],
        "generic_name": [
          "PETROLATUM 36%"
        ],
        "manufacturer_name": [
          "Beyond Health P.A."
        ],
        "product_ndc": [
          "70942-017"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MINERAL OIL"
        ],
        "spl_id": [
          "2958cebe-650d-ea65-e063-6394a90a3f39"
        ],
        "spl_set_id": [
          "d17a0c28-a5b7-4df0-e053-2995a90a8edd"
        ],
        "package_ndc": [
          "70942-017-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850016254214",
          "0850016254221"
        ],
        "unii": [
          "T5L8T28FGP"
        ]
      }
    }
  ]
}