{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "White Petrolatum Petrolatum PETROLATUM PETROLATUM"
      ],
      "active_ingredient": [
        "Active Ingredient White Petrolatum 100%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and relieves minor cuts scrapes burns chapped or cracked skin and lips"
      ],
      "stop_use": [
        "Stop use and ask a doctor Condition worsens Symptoms last more than 7 days or clear up and occur again with a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately"
      ],
      "when_using": [
        "When using this product Avoid contact with eyes"
      ],
      "do_not_use": [
        "Do Not Use On deep or puncture wounds Animal Bites Serious Burns"
      ],
      "dosage_and_administration": [
        "Directions Apply as needed"
      ],
      "inactive_ingredient": [
        "Inactive ingredients mineral oil, vitamin A Palmitate, vitamin D3, Microcrystalline Wax, Paraffin"
      ],
      "spl_unclassified_section": [
        "Distributed By Trifecta Pharmaceuticals USA 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 www.trifecta-pharma.com 1-888-296-9067"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "questions": [
        "Questions Call: 1-888-296-9067"
      ],
      "storage_and_handling": [
        "Store at room temperature 20º-25ºC (68º-77ºF) Tamper evident, do not use if packet is torn, cut or opened Avoid excessive heat and humidity"
      ],
      "package_label_principal_display_panel": [
        "Package Label Globe White Petrolatum 5g CDER"
      ],
      "set_id": "f1eb0ec2-98e7-13a2-e053-2a95a90a2938",
      "id": "29b3e33a-5451-40b4-e063-6394a90a1107",
      "effective_time": "20241220",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "White Petrolatum"
        ],
        "generic_name": [
          "PETROLATUM"
        ],
        "manufacturer_name": [
          "Trifecta Pharmaceuticals USA LLC"
        ],
        "product_ndc": [
          "69396-114"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PETROLATUM"
        ],
        "rxcui": [
          "204754"
        ],
        "spl_id": [
          "29b3e33a-5451-40b4-e063-6394a90a1107"
        ],
        "spl_set_id": [
          "f1eb0ec2-98e7-13a2-e053-2a95a90a2938"
        ],
        "package_ndc": [
          "69396-114-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850026393590"
        ],
        "unii": [
          "4T6H12BN9U"
        ]
      }
    }
  ]
}