{
  "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": [
        "Scarzen DIMETHICONE WATER ALOE VERA LEAF GLYCERYL MONOSTEARATE PEG-100 MONOSTEARATE STEARIC ACID CETYL ALCOHOL BUTYLENE GLYCOL GLYCERIN SODIUM ASCORBYL PHOSPHATE HYALURONIC ACID GINGER PYRIDOXINE HYDROCHLORIDE PANTOTHENIC ACID SAFFLOWER EDETATE DISODIUM ANHYDROUS SILICON DIOXIDE TROLAMINE PHENOXYETHANOL ETHYLHEXYLGLYCERIN DIMETHICONE, UNSPECIFIED DIMETHICONE"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS:"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS: Dimethicone 5.00% Skin Protectant"
      ],
      "purpose": [
        "Skin Protectant"
      ],
      "indications_and_usage": [
        "USES: Temporarily protects and helps relieve chapped or cracked skin"
      ],
      "warnings": [
        "WARNINGS: • For external use only. • Avoid contact with eyes. Stop use and ask a doctor • if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days. Do not use on deep or puncture wounds, animal bites or serious burns. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "stop_use": [
        "Stop use and ask a doctor • if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days."
      ],
      "do_not_use": [
        "Do not use on deep or puncture wounds, animal bites or serious burns."
      ],
      "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 (Adults and Children Over 12 Years): Cleanse the affected area and allow to dry. Apply as needed."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: Aqua (Deionized Water), Aloe Barbadensis (Aloe Vera Gel) Juice, Glyceryl Stearate, PEG-100 Stearate, Carthamus Tinctorius (Sunflower) Oil, Stearic Acid, Cetyl Alcohol, Butylene Glycol, Glycerin, Sodium Ascorbyl Phosphate (Vitamin C), Tocopheryl Acetate (Vitamin E), Hyaluronic Acid, Zingiber Officinale (Ginger) Extract, Pyridoxine HCL (Vitamin B6), Pantothenic Acid (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Disodium EDTA, Silica, Triethanolamine, Parfum (Fragrance), Phenoxyethanol, Ethylhexylglycerin."
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "1550f4e5-22e2-491f-8184-de65da7234e6",
      "id": "5672d48b-d218-46bd-8d40-c77bb6abf1ef",
      "effective_time": "20260101",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Scarzen"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Village Pharma LLC"
        ],
        "product_ndc": [
          "71574-500"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE, UNSPECIFIED"
        ],
        "rxcui": [
          "1602161"
        ],
        "spl_id": [
          "5672d48b-d218-46bd-8d40-c77bb6abf1ef"
        ],
        "spl_set_id": [
          "1550f4e5-22e2-491f-8184-de65da7234e6"
        ],
        "package_ndc": [
          "71574-500-72"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0371574500723"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}