{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Comfort Shield Barrier dimethicone WATER GLYCERYL MONOSTEARATE PEG-100 STEARATE ISOPROPYL PALMITATE CETYL ALCOHOL GLYCERIN STEARYL ALCOHOL PHENOXYETHANOL METHYLPROPANEDIOL CHLORHEXIDINE GLUCONATE HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) ETHYLHEXYLGLYCERIN POLYQUATERNIUM-37 (25000 MPA.S) PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE GLUCONOLACTONE PPG-1 TRIDECETH-6 DIMETHICONE DIMETHICONE"
      ],
      "active_ingredient": [
        "Active Ingredient Dimethicone 3%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses helps seal out wetness helps treat and prevent perineal dermatitis protects from minor skin irritation associated with perineal dermatitis"
      ],
      "warnings": [
        "Warnings For external perineal use only. Avoid contact with the eyes. Stop use and consult a doctor if condition worsens or does not improve within 7 days Keep out of reach of children. 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. 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 cloth after use - DO NOT FLUSH CLOTHS use as often as necessary, especially if prolonged exposure to wetness is anticipated for individual use only reseal label between uses discard package immediately if cloths are dry If warming is desired: peel open label without completely removing it heat entire package in microwave no longer than [see package for time]. since microwave wattage varies, adjust heating time accordingly Comfort Shield® may also be used at room temperature or warmed in a Comfort Personal Cleansing Warmer. Caution: If there is any indication barrier cloths are excessively hot, do not use Remember, gloves diminish your sensitivity to heat Closely monitor heat level with infants, unresponsive or skin sensitive individuals"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, cetyl alcohol, glycerin, stearyl alcohol, phenoxyethanol, methylpropanediol, chlorhexidine gluconate, hydroxyethyl cellulose, ethylhexylglycerin, polyquaternium-37, propylene glycol dicaprylate/dicaprate, glucono-delta-lactone, PPG-1 trideceth-6 Barrier cloths: cellulose fiber/polyester (PET) fiber"
      ],
      "questions": [
        "Questions or Comments? 800-323-2220"
      ],
      "package_label_principal_display_panel": [
        "Comfort Shield Barrier R5549_7803 R4157N R5545 R6223B R5548 R5567C"
      ],
      "set_id": "cc08f571-84ae-4c2f-b09d-a83a8efc39f5",
      "id": "54ee06dc-1e51-3f8a-e063-6294a90a1fb0",
      "effective_time": "20260623",
      "version": "17",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Comfort Shield Barrier"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Sage Products LLC"
        ],
        "product_ndc": [
          "53462-915"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "968663",
          "1088604"
        ],
        "spl_id": [
          "54ee06dc-1e51-3f8a-e063-6294a90a1fb0"
        ],
        "spl_set_id": [
          "cc08f571-84ae-4c2f-b09d-a83a8efc39f5"
        ],
        "package_ndc": [
          "53462-915-50",
          "53462-915-51",
          "53462-915-62",
          "53462-915-80",
          "53462-915-81",
          "53462-915-24"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}