{
  "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,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Personal Cleansing with Dimethicone DIMETHICONE WATER GLYCERIN PPG-15 STEARYL ETHER GLYCERYL MONOSTEARATE PEG-100 STEARATE PHENOXYETHANOL ALOE VERA LEAF CAPRYLYL GLYCOL CETOSTEARYL ALCOHOL XANTHAN GUM DIMETHICONE DIMETHICONE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other Information When not in a warmer, store between 15-30˚C (59-86˚F)."
      ],
      "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 Pull back label 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, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Cetearyl Alcohol, Xanthan Gum"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Product Label French Translation for Drug Facts Panel Drug Facts Panel"
      ],
      "set_id": "3f9a1a90-ab12-4911-b8c2-df200b0dde5b",
      "id": "2a4492f5-13ea-333d-e063-6394a90aa026",
      "effective_time": "20241227",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Personal Cleansing with Dimethicone"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Cardinal Health 200, Inc"
        ],
        "product_ndc": [
          "63517-126"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "1039149"
        ],
        "spl_id": [
          "2a4492f5-13ea-333d-e063-6394a90aa026"
        ],
        "spl_set_id": [
          "3f9a1a90-ab12-4911-b8c2-df200b0dde5b"
        ],
        "package_ndc": [
          "63517-126-21"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}