{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Claravie Dimethicone DIMETHICONE DIMETHICONE WATER GLYCERYL MONOSTEARATE STEARIC ACID PEG-100 MONOSTEARATE CETOSTEARYL ALCOHOL GLYCERIN PROPYLENE GLYCOL NIACINAMIDE PHENOXYETHANOL ALOE VERA LEAF ZEA MAYS (CORN) OIL CARBOMER TROLAMINE EDETATE DISODIUM ORANGE OIL CANOLA OIL CITRUS LIMON (LEMON) PEEL OIL LAVENDER OIL OLIVE OIL .ALPHA.-TOCOPHEROL ACETATE ASCORBYL PALMITATE PYRIDOXINE HCL VITAMIN A PALMITATE CHOLECALCIFEROL ETHYLHEXYLGLYCERIN"
      ],
      "description": [
        "Powered by nature, perfected by science—the ClaraVie™ skin care collection offers a harmonious blend of advanced technology and natural ingredients for radiant, healthy skin."
      ],
      "active_ingredient": [
        "Active ingredients Dimethicone 5% w/w"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve chafed, chapped or cracked skin. Helps protect from the drying effects of wind and cold weather. Helps prevent and undergarment rash. Protects minor skin irritation associated with undergarment rash and helps seal out wetness."
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product do not get in eyes."
      ],
      "stop_use": [
        "Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear and occur again within a few days."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children In case of accidental ingestion, contact a physician or Poison Control Center."
      ],
      "instructions_for_use": [
        "Directions As a skin protectant: Apply as needed As an undergarment cream: Change wet and soiled undergarment promptly, because the undergarment area and allow to dry. Apply cream liberally as often as necessary with each undergarment change, especially at bedtime or anytime when exposure to wet undergarment may be prolonged."
      ],
      "storage_and_handling": [
        "Other Information Store between 59°F-86°F (15°C-30°C)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Phenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, EDTA Disodium, Orange Oil, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, Alpha Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin"
      ],
      "questions": [
        "1-800-840-9041 • www.gentell.com"
      ],
      "dosage_and_administration": [
        "Apply cream liberally as often as necessary with each undergarment change, especially at bedtime or anytime when exposure to wet undergarment may be prolonged."
      ],
      "package_label_principal_display_panel": [
        "Dimethicone Skin Protectant Dimethicone Skin Protectant Label: Dimethicone Protectant"
      ],
      "set_id": "59c6da39-b5f1-8253-e063-6394a90a0e8f",
      "id": "59c6da39-b5f2-8253-e063-6394a90a0e8f",
      "effective_time": "20260824",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Claravie"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Gentell LLC"
        ],
        "product_ndc": [
          "61554-313"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "spl_id": [
          "59c6da39-b5f2-8253-e063-6394a90a0e8f"
        ],
        "spl_set_id": [
          "59c6da39-b5f1-8253-e063-6394a90a0e8f"
        ],
        "package_ndc": [
          "61554-313-11"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}