{
  "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,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "DERMOGEN ZINC OXIDE ZINC OXIDE ZINC CATION BUTYLATED HYDROXYTOLUENE DIAZOLIDINYL UREA METHYLPARABEN MINERAL OIL PROPYLENE GLYCOL PROPYLPARABEN VITAMIN A VITAMIN D .ALPHA.-TOCOPHEROL PETROLATUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "For the Treatment & Prevention of Diaper Rash Contains the same active ingredient as Dermocrem ® Manufactured in the USA for Kramer Novis, San Juan, PR 00917. T: (787) 767-2072. www.kramernovis.com Dermocrem ® is a registered trademark of Forest Tosara Ltd. This product is not manufactured, distributed or marketed by Forest Tosara Ltd."
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide 15.25%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses • helps treat and prevent diaper rash • protects chafed skin due to diaper rash and helps seal out wetness"
      ],
      "warnings": [
        "Warning ​• For external use only. When using this product • do not get into eyes Stop and ask a doctor if • condition worsens • symptoms lasts 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."
      ],
      "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 or soiled diapers promptly. • cleanse the diaper area • allow to dry • apply cream liberally as often as necessary, with each diaper, especially at bedtime or anytime when exposure to wet diapers may be prolonged"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Butylhydroxytoluene, diazolidinyl urea, fragrance, methylparaben, mineral oil, propylene glycol, propylparaben, Vitamin A, Vitamin D, Vitamin E and white petrolatum."
      ],
      "storage_and_handling": [
        "Other information • Store at controlled room temperature 15°-30°C (59°-86°F) • Do not use if seal is broken"
      ],
      "package_label_principal_display_panel": [
        "Packaging DERMOGEN"
      ],
      "set_id": "38e02d1c-c143-4da6-ad32-a3ce2861aac5",
      "id": "2a461bfd-7006-4b64-addf-474ee1fbd48f",
      "effective_time": "20251114",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "DERMOGEN"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "KRAMER NOVIS"
        ],
        "product_ndc": [
          "52083-680"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1793915"
        ],
        "spl_id": [
          "2a461bfd-7006-4b64-addf-474ee1fbd48f"
        ],
        "spl_set_id": [
          "38e02d1c-c143-4da6-ad32-a3ce2861aac5"
        ],
        "package_ndc": [
          "52083-680-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}