{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Selan Plus Zinc Oxide Selan Plus Zinc Oxide WATER CETYL ALCOHOL GLYCERYL MONOSTEARATE LANOLIN SORBITOL SODIUM LAURYL SULFATE METHYLPARABEN PROPYLPARABEN ZINC OXIDE ZINC OXIDE DIMETHICONE DIMETHICONE"
      ],
      "active_ingredient": [
        "Active Ingredients Dimethicone 2.1% Zinc Oxide 2%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps treat and prevent diaper rash Protects chaged skin or minor skin irritation due to diaper rash and helps seal out wetness"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product avoid contact with the eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or does not improve within 7 days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away"
      ],
      "dosage_and_administration": [
        "Directions apply cream liberally as often as necessary change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply cream with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged"
      ],
      "storage_and_handling": [
        "Other Information: Store at room temperature"
      ],
      "inactive_ingredient": [
        "Purified Water USP, Cetyl Alcohol, Sorbitol USP, Glycerol Monostearate, Sodium Lauryl Sulfate, Lanolin USP, Methylparaben, Fragrance, Propylparaben."
      ],
      "package_label_principal_display_panel": [
        "Image of 4oz tube SelanZinc4ozTube.jpg Image of 4oz tube artwork",
        "Image of 16oz jar SelanZinc16ozJar.jpg Image of 16oz Jar Artwork",
        "Image of 8ml packet SelanZinc8mlPacket.jpg Image of Selan Zinc 8mL Packet Artwork"
      ],
      "set_id": "07396c61-1dfd-4be7-bddf-0eb570a18463",
      "id": "4dc6d821-5996-c36c-e063-6394a90a41e4",
      "effective_time": "20260324",
      "version": "6",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Selan Plus Zinc Oxide"
        ],
        "generic_name": [
          "SELAN PLUS ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Trividia Manufacturing Solutions, Inc"
        ],
        "product_ndc": [
          "0159-2200"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1373379"
        ],
        "spl_id": [
          "4dc6d821-5996-c36c-e063-6394a90a41e4"
        ],
        "spl_set_id": [
          "07396c61-1dfd-4be7-bddf-0eb570a18463"
        ],
        "package_ndc": [
          "0159-2200-04",
          "0159-2200-01",
          "0159-2200-17"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0048932220165"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}