{
  "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": [
        "MediChoice Barrier 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",
        "If heating is desired: • Peel open label without completely removing it, heat entire package in microwave for no longer than 45 seconds. Check the temperature of cloths as microwave wattage varies. May also used at room temperature. • Ensure temperature of washcloths is not excessively hot. Gloves diminish sensitivity to heat. Closely monitor heat level with infants, unresponsive or skin sensitive individuals.",
        "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 from minor skin irritation associated with perineal dermatitis"
      ],
      "warnings": [
        "Warnings For external use only. Keep out of eyes, ears and mouth. Stop use and consult a doctor if condition worsens or does not improve within 7 days. Keep out of reach of children except with adult supervision. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "stop_use": [
        "Stop use and consult a doctor if condition worsens or does not improve within 7 days."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children except with adult supervision. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions • Remove wet and soiled garment. • Cleanse soiled area using a fresh barrier cream cloth. • Discard wipe after use. • Do not flush. • For individual use only. • Reseal label between uses."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aqua, Glycerin, Cetearyl Alcohol, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Capryly Glycol, Xanthan Gum"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Inner Package Outer Package",
        "Package Labeling: Label04"
      ],
      "set_id": "42477582-3ffa-4e51-a29b-86da07b14382",
      "id": "4d3ac95d-578a-033a-e063-6394a90ae5d5",
      "effective_time": "20260317",
      "version": "3",
      "openfda": {
        "application_number": [
          "OKM016"
        ],
        "brand_name": [
          "MediChoice Barrier"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "O&M HALYARD, INC."
        ],
        "product_ndc": [
          "39892-0951"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "1039149"
        ],
        "spl_id": [
          "4d3ac95d-578a-033a-e063-6394a90ae5d5"
        ],
        "spl_set_id": [
          "42477582-3ffa-4e51-a29b-86da07b14382"
        ],
        "package_ndc": [
          "39892-0951-1",
          "39892-0951-2"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}