{
  "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": [
        "Aluroderm Scar allantoin ALLANTOIN ALLANTOIN CARBOXYMETHYLCELLULOSE SODIUM HYALURONIC ACID TAXIFOLIN POLYURETHANE-39"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS Allantoin 0.75%"
      ],
      "purpose": [
        "PURPOSE Skin Protectant"
      ],
      "indications_and_usage": [
        "USES -Scar Management -Temporarily protects and helps relieve chapped or cracked skin"
      ],
      "warnings": [
        "WARNINGS FOR EXTERNAL USE ONLY"
      ],
      "do_not_use": [
        "DO NOT USE -On deep punctures, serious burns, or infected skin"
      ],
      "when_using": [
        "WHEN USING THIS PRODUCT Avoid contact with the eyes"
      ],
      "stop_use": [
        "STOP USE AND ASK DOCTOR IF -Condition worsens -Excessive skin irritation develops -Condition persists for more than 7 days, or condition clears up and occurs again within 3 days"
      ],
      "pregnancy_or_breast_feeding": [
        "IF PREGNANT OR BREASTFEEDING Consult a physician before use"
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN If ingested, seek medical help or contact Poison Control immediately"
      ],
      "dosage_and_administration": [
        "DIRECTIONS Adults and Children 12 Years of Age and Older -Clean and dry the affected area -Apply as needed"
      ],
      "spl_unclassified_section": [
        "OTHER INFORMATION -Store at room temperature",
        "QUESTIONS OR COMMENTS info@olakinotherapeutics.com"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Hyaluronic Acid, Taxifolin, Polyurethane, Sodium Carboxymethyl Cellulose"
      ],
      "package_label_principal_display_panel": [
        "pouch box"
      ],
      "set_id": "2a848dde-8fc4-ab10-e063-6294a90a2583",
      "id": "2d94d970-563c-466c-e063-6294a90a93db",
      "effective_time": "20250207",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Aluroderm Scar"
        ],
        "generic_name": [
          "ALLANTOIN"
        ],
        "manufacturer_name": [
          "Olakino Therapeutics LLC"
        ],
        "product_ndc": [
          "84991-0316"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "CUTANEOUS"
        ],
        "substance_name": [
          "ALLANTOIN"
        ],
        "rxcui": [
          "2711688"
        ],
        "spl_id": [
          "2d94d970-563c-466c-e063-6294a90a93db"
        ],
        "spl_set_id": [
          "2a848dde-8fc4-ab10-e063-6294a90a2583"
        ],
        "package_ndc": [
          "84991-0316-1",
          "84991-0316-5"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0384991031619",
          "0384997031651"
        ],
        "unii": [
          "344S277G0Z"
        ]
      }
    }
  ]
}