{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Vitamin A and D Lanolin, Petrolatum MICROCRYSTALLINE WAX PARAFFIN PETROLATUM PETROLATUM COD LIVER OIL MINERAL OIL LANOLIN LANOLIN"
      ],
      "active_ingredient": [
        "Active Ingredient Lanolin 15.5% Petrolatum 53.4%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness"
      ],
      "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 our of reach of children If swallowed, get medical help or contact a Poison Control Center immediately"
      ],
      "dosage_and_administration": [
        "Directions Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Cod liver oil (contains Vitamin A and Vitamin D), Fragrance, Mineral Oil, Microcrystalline Wax, Paraffin"
      ],
      "spl_unclassified_section": [
        "Distributed by Trifecta Pharmaceuticals USA 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 Product of PRC www.trifecta-pharma.com"
      ],
      "warnings": [
        "Warnings For external use only When using this product avoid contact with eyes"
      ],
      "storage_and_handling": [
        "Store at controlled room temperature 20º 25ºC (68º-77ºF) Questions 1-888-296-9067"
      ],
      "package_label_principal_display_panel": [
        "Packaging globe_vitamin_AD"
      ],
      "set_id": "453dffec-de9d-0eac-e054-00144ff8d46c",
      "id": "29b3cf7a-794a-6a29-e063-6294a90ac3d7",
      "effective_time": "20241220",
      "version": "4",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Vitamin A and D"
        ],
        "generic_name": [
          "LANOLIN, PETROLATUM"
        ],
        "manufacturer_name": [
          "Trifecta Pharmaceuticals USA LLC"
        ],
        "product_ndc": [
          "69396-009"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PETROLATUM",
          "LANOLIN"
        ],
        "rxcui": [
          "664981"
        ],
        "spl_id": [
          "29b3cf7a-794a-6a29-e063-6294a90ac3d7"
        ],
        "spl_set_id": [
          "453dffec-de9d-0eac-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "69396-009-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4T6H12BN9U",
          "7EV65EAW6H"
        ]
      }
    }
  ]
}