{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Manuka Honey Extra Strength ALLANTOIN PROPANEDIOL POTASSIUM SORBATE ROSEMARY SODIUM BENZOATE TETRASODIUM GLUTAMATE DIACETATE TOCOPHEROL WATER ALLANTOIN ALLANTOIN"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Allantoin 0.5% Purpose Skin Protectant"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects minor cuts scrapes burns helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin"
      ],
      "warnings": [
        "Warnings For external use only Do not use In the eyes On deep or puncture wounds Animal bites Serious burns Stop use and ask a doctor if Conditions worsen Symptoms last 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."
      ],
      "do_not_use": [
        "Do not use In the eyes On deep or puncture wounds Animal bites Serious burns"
      ],
      "stop_use": [
        "Stop use and ask a doctor if Conditions worsen 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 right away."
      ],
      "dosage_and_administration": [
        "Directions Apply as needed."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Helianthus Annuus Extract, Lecithin, Mãnuka Honey, Oryza Sativa Bran Extract, Propanediol, Potassium Sorbate, Rosmarinus Officinalis Leaf Extract, Sodium Acrylates Copolymer, Sodium Benzoate, Tetrasodium Glutamate Diacetate, Tocopherol, Water (Aqua)."
      ],
      "questions": [
        "Questions? 1-615-488-8168"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "b742585d-9a0c-489b-b268-590583cfabd1",
      "id": "2d5e1f54-b018-fce5-e063-6394a90a76d7",
      "effective_time": "20250204",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Manuka Honey Extra Strength"
        ],
        "generic_name": [
          "ALLANTOIN"
        ],
        "manufacturer_name": [
          "First Honey LLC"
        ],
        "product_ndc": [
          "81995-050"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ALLANTOIN"
        ],
        "spl_id": [
          "2d5e1f54-b018-fce5-e063-6394a90a76d7"
        ],
        "spl_set_id": [
          "b742585d-9a0c-489b-b268-590583cfabd1"
        ],
        "package_ndc": [
          "81995-050-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0854056008356"
        ],
        "unii": [
          "344S277G0Z"
        ]
      }
    }
  ]
}