{
  "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,
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    }
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  "results": [
    {
      "spl_product_data_elements": [
        "ProCure Moisture Barrier 1% Dimethicone, 12% ZInc Oxide CORN OIL IMIDAZOLIDINYL UREA LANOLIN ZINC OXIDE ZINC OXIDE MINERAL OIL WATER PARAFFIN ALOE VERA LEAF CHOLECALCIFEROL PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE SORBITAN SESQUIOLEATE VITAMIN A PALMITATE PETROLATUM CHLOROXYLENOL PROPYLENE GLYCOL DIMETHICONE DIMETHICONE ETHYLHEXYLGLYCERIN ALUMINUM STEARATE BEESWAX White to Off White Color"
      ],
      "active_ingredient": [
        "Active Ingredients Dimethicone 1% w/w Zinc Oxide 12% w/w"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness."
      ],
      "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 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"
      ],
      "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 Directions Change wet and soiled diaper promptly Cleanse the diaper area, and allow to dry Apply cream 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 Inactive Ingredients Aloe Barbadensis Leaf Extract, Aluminum Stearate, Beeswax, Cholecalciferol, Chloroxylenol, Corn Oil, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Lanolin, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sorbitan Sesquioleate, Tocopherol Acetate, Vitamin A Palmitate, Water"
      ],
      "package_label_principal_display_panel": [
        "PCGDZ04 Image"
      ],
      "set_id": "3988c83b-d4eb-1f09-e063-6394a90a45ad",
      "id": "39eea0b7-df3d-a70e-e063-6294a90a19ea",
      "effective_time": "20250714",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "ProCure Moisture Barrier"
        ],
        "generic_name": [
          "1% DIMETHICONE, 12% ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Twin Med LLC"
        ],
        "product_ndc": [
          "55681-025"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "DIMETHICONE"
        ],
        "spl_id": [
          "39eea0b7-df3d-a70e-e063-6294a90a19ea"
        ],
        "spl_set_id": [
          "3988c83b-d4eb-1f09-e063-6394a90a45ad"
        ],
        "package_ndc": [
          "55681-025-04"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "SOI2LOH54Z",
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}