{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "INCONTINENCE CARE WIPE DIMETHICONE WATER GLYCERIN CETOSTEARYL ALCOHOL PPG-15 STEARYL ETHER GLYCERYL MONOSTEARATE PEG-100 STEARATE PHENOXYETHANOL ALOE VERA LEAF CAPRYLYL GLYCOL XANTHAN GUM DIMETHICONE DIMETHICONE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other Information Store at room temperature."
      ],
      "active_ingredient": [
        "Active Ingredient Dimethicone 3.2% Purpose Skin Protectant"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily protects and helps relieve chapped or cracked skin helps prevent perineal dermatitis protects minor skin irritation associated with perineal dermatitis"
      ],
      "warnings": [
        "Warnings For external use only When using this product Avoid direct contact with the eyes Stop use and contact a physician 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. If swallowed, get medical help or contact Posion Control Center right away. Discontinue if irritation or redness develops Gloves diminish sensitivity to heat Closely monitor heat level with infants, unresponsive or skin sensitive individuals Do not use On deep or puncture wounds Animal bites Serious burns"
      ],
      "when_using": [
        "When using this product Avoid direct contact with the eyes"
      ],
      "stop_use": [
        "Stop use and contact a physician 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. If swallowed, get medical help or contact Posion Control Center right away. Discontinue if irritation or redness develops Gloves diminish sensitivity to heat Closely monitor heat level with infants, unresponsive or skin sensitive individuals"
      ],
      "do_not_use": [
        "Do not use On deep or puncture wounds Animal bites Serious burns"
      ],
      "dosage_and_administration": [
        "Directions Tear open pouch and remove wipes Thoroughly cleanse soiled area, using one wipe at a time Use as often as necessary Dispose of cloths in a waste receptacle Do not flush Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed: In a single warming session at temperatures not exceeding 52°C (125°F) and for a maximum of 200 hours. Discard wipes that have been: Exposed to warming temperatures exceeding 52°C (125°F); or Stored longer than 200 hours within the warmer; or Been warmed, allowed to cool, and then re-warmed Warming Instructions:"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aqua, Glycerin, Cetearyl Alcohol, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Xanthan Gum"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label2"
      ],
      "set_id": "1ac34c94-9e3b-45f2-ba19-a07dcd3941dd",
      "id": "48735d8d-1680-1895-e063-6294a90afb91",
      "effective_time": "20260115",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "INCONTINENCE CARE WIPE"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Cardinal Health 200, Inc."
        ],
        "product_ndc": [
          "63517-131"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "1039149"
        ],
        "spl_id": [
          "48735d8d-1680-1895-e063-6294a90afb91"
        ],
        "spl_set_id": [
          "1ac34c94-9e3b-45f2-ba19-a07dcd3941dd"
        ],
        "package_ndc": [
          "63517-131-22"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0888499011376"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}