{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Medline Dimethicone GLYCERYL STEARATE PANTHENOL PROPYLENE GLYCOL SOYBEAN OIL ALLANTOIN METHYLPARABEN PROPYLPARABEN ISOPROPYL PALMITATE DIMETHICONE DIMETHICONE GLYCERIN SODIUM LAUROYL LACTYLATE .ALPHA.-TOCOPHEROL ACETATE ZINC RICINOLEATE CITRIC ACID WATER CETEARYL ALCOHOL DIAZOLIDINYL UREA"
      ],
      "active_ingredient": [
        "Active ingredient Dimethicone 2% (w/v)"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Use helps treat and prevent diaper rash. Protect minor skin irritation due to diaper rash and helps seal out wetness."
      ],
      "warnings": [
        "Warnings For external use only. Do not use on deep or puncture wounds animal bites serious burns. When using this product do not get into eyes Stop use and ask a doctor 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 a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use on deep or puncture wounds animal bites serious burns."
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor 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 a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions change wet and soiled diapers promptly spray affected area and gently wipe with clean, soft cloth to cleanse apply product liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged."
      ],
      "inactive_ingredient": [
        "Inactive ingredients allantoin, cetearyl alcohol, citric acid, diazolidinyl urea, fragrance, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, panthenol, propylene glycol, propylparaben, sodium lauroyl lactylate, soybean oil, tocopheryl acetate (vitamin E), water, zinc ricinoleate."
      ],
      "storage_and_handling": [
        "Other information protect from freezing avoid excessive heat store at 15ºC - 30ºC (59ºF - 86ºF)"
      ],
      "questions": [
        "Questions? 1-800-MEDLINE (633-5463)"
      ],
      "spl_unclassified_section": [
        "Manufacturing Information www.medline.com ©2025 Medline, Medline Remedy and Baza are registered trademarks of Medline Industries, LP. Manufactured by: Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA. Made in USA of foreign and domestic materials 1-800-MEDLINE"
      ],
      "package_label_principal_display_panel": [
        "Package Label Package Label"
      ],
      "set_id": "509ee758-9d53-220c-e063-6394a90a4bd5",
      "id": "509ee758-9d54-220c-e063-6394a90a4bd5",
      "effective_time": "20260609",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Medline"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-251"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "198605"
        ],
        "spl_id": [
          "509ee758-9d54-220c-e063-6394a90a4bd5"
        ],
        "spl_set_id": [
          "509ee758-9d53-220c-e063-6394a90a4bd5"
        ],
        "package_ndc": [
          "53329-251-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0197344161372"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}