{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "TENA PROSKIN BARRIER DIMETHICONE WATER DICAPRYLYL CARBONATE GLYCERIN PEG-8 BEESWAX CETYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL STEARATE SE SODIUM CITRATE CETETH-20 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) PHENOXYETHANOL SORBITAN MONOCAPRYLATE SODIUM BENZOATE STEARETH-20 HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) HELIANTHUS ANNUUS SEED WAX ANHYDROUS CITRIC ACID SODIUM GLUCONATE ETHYLHEXYLGLYCERIN XANTHAN GUM ACACIA DECURRENS FLOWER WAX POLYGLYCERIN-3 TOCOPHEROL DIMETHICONE DIMETHICONE"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Dimethicone 5%"
      ],
      "purpose": [
        "PURPOSE Skin Protectant"
      ],
      "indications_and_usage": [
        "USES protects skin from irritation casued by contact with urine and/or stool helps prevent and releive chafed, chapped, or cracked skin"
      ],
      "warnings": [
        "WARNINGS For external use only. Do not use on deep or puncture wounds on animal bites on 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": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "DIRECTIONS cleanse skin with TENA PROSKIN Cleansing Cream and/or TENA PROSKIN WIPES apply cream liberally and reapply as needed"
      ],
      "storage_and_handling": [
        "OTHER INFORMATION Store between 32°F and 85°F"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Water, Dicaprylyl Carbonate, Glycerin, PEG-8 Beeswax, Cetyl Alcohol, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Sodium Citrate, Ceteth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sorbitan Caprylate, Sodium Benzoate, Steareth-20, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Citric Acid, Sodium Gluconate, Ethylhexylglycerin, Xanthan Gum, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol."
      ],
      "questions": [
        "QUESTIONS OR COMMENTS? Call 1-800-992-9939 or visit www.tena.us TENA® Consumer Care Center P.O. Box 8091 Eau Claire, WI 54702-8091"
      ],
      "package_label_principal_display_panel": [
        "01b LBL_Tena_Barrier Cream_100mL"
      ],
      "set_id": "118bf2df-ee7b-454f-9c0b-2697dc826268",
      "id": "467a1ea7-0abf-bd8a-e063-6394a90ae073",
      "effective_time": "20251221",
      "version": "9",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "TENA PROSKIN BARRIER"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Essity HMS North America Inc"
        ],
        "product_ndc": [
          "59608-006"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "spl_id": [
          "467a1ea7-0abf-bd8a-e063-6394a90ae073"
        ],
        "spl_set_id": [
          "118bf2df-ee7b-454f-9c0b-2697dc826268"
        ],
        "package_ndc": [
          "59608-006-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}