{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "ProCure SkinGuard Petrolatum 49.9% LANOLIN ALUMINUM STEARATE CORN OIL PHENOXYETHANOL ALOE VERA LEAF ZINC OXIDE .ALPHA.-TOCOPHEROL ACETATE SORBITAN SESQUIOLEATE PETROLATUM PETROLATUM PARAFFIN ETHYLHEXYLGLYCERIN CHLOROXYLENOL WATER PROPYLENE GLYCOL CHOLECALCIFEROL VITAMIN A PALMITATE IMIDUREA YELLOW WAX MINERAL OIL"
      ],
      "active_ingredient": [
        "Active Ingredient Petrolatum 49.9%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps treat and prevent incontinence or diaper rash Protects chafed skin associated with incontinence or diaper rash and helps seal out wetness Temporarily protects and helps relieve chafed, chapped or cracked skin"
      ],
      "warnings": [
        "Warnings Warnings For External Use Only When using this product When using this product do not get into the eyes Stop use and ask a doctor if 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 Do not use on Do not use on deep or puncture wounds, animal bites, or serious burns Keep out of reach of children Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away."
      ],
      "when_using": [
        "When using this product When using this product do not get into the eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if 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"
      ],
      "do_not_use": [
        "Do not use on Do not use on deep or puncture wounds, animal bites, or serious burns"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions For skin protectant use: apply as needed For incontinence or diaper rash: Change wet and soiled undergarments promptly Gently cleanse affected skin, and allow to dry Apply ointment liberally as often as necessary, with each undergarment change, especially at bedtime or anytime when exposure to wet diapers may be prolonged",
        "Directions For skin protectant use: apply as needed For incontinence or diaper rash: Change wet and soiled undergarments promptly Gently cleanse affected skin, and allow to dry Apply ointment liberally as often as necessary, with each undergarment change, especially at bedtime or anytime when exposure to wet diapers may be prolonged"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Mineral Oil, Water, Propylene Glycol, Paraffin, Zinc Oxide, Sorbitan Sesquioleate, Lanolin, Beeswax, Aluminum Stearate, Corn Oil, Phenoxyethanol, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Chloroxylenol, Aloe Barbadensis Leaf Extract, Cholecalciferol, Vitamin A Palmitate, Vitamin E Acetate"
      ],
      "package_label_principal_display_panel": [
        "PCPG35 Image"
      ],
      "set_id": "3a1721f6-1bb0-cd47-e063-6394a90a148e",
      "id": "3ac23056-720f-eca5-e063-6394a90a8cc7",
      "effective_time": "20250725",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "ProCure SkinGuard"
        ],
        "generic_name": [
          "PETROLATUM 49.9%"
        ],
        "manufacturer_name": [
          "Twin Med LLC"
        ],
        "product_ndc": [
          "55681-030"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PETROLATUM"
        ],
        "rxcui": [
          "2719616"
        ],
        "spl_id": [
          "3ac23056-720f-eca5-e063-6394a90a8cc7"
        ],
        "spl_set_id": [
          "3a1721f6-1bb0-cd47-e063-6394a90a148e"
        ],
        "package_ndc": [
          "55681-030-04",
          "55681-030-07",
          "55681-030-05",
          "55681-030-14"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4T6H12BN9U"
        ]
      }
    }
  ]
}