{
  "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": "2026-07-23",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Curoxen Oral Care Olive Extract, Calendula, Clove Oil CINNAMON OIL OLIVE OIL CLOVE OIL CLOVE OIL OLEA EUROPAEA FRUIT VOLATILE OIL OLEA EUROPAEA FRUIT VOLATILE OIL CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Made in Italy Distributed by OrganiCare®, Austin, TX 78744"
      ],
      "active_ingredient": [
        "Active ingredients Calendula 3X HPUS Clove essential oil 1X Olive extract 2X HPUS"
      ],
      "purpose": [
        "Purposes Healing agent Oral pain reliever Oral antimicrobial and healing agent"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of pain and to help prevent infection and promote healing of: canker sores cold sores fever blisters minor irritation, injury, cuts or other sores of the mouth and gums."
      ],
      "warnings": [
        "Warnings"
      ],
      "stop_use": [
        "Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days swelling, rash, fever or other allergic reaction develops irritation, pain or redness persists or worsens"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If excessive product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children of any age, apply to the affected area as needed Children under 12 years of age should be supervised in the use of this product"
      ],
      "storage_and_handling": [
        "Other information store at 68° to 77°F (20° to 25°C) if liquefied, refrigerate 10 minutes to thicken"
      ],
      "inactive_ingredient": [
        "Inactive ingredients oxygenated olive oil, pure essential oil (cinnamon)"
      ],
      "questions": [
        "Questions? Call 512-401-3572 or visit www.curoxen.com"
      ],
      "package_label_principal_display_panel": [
        "MADE WITH ORGANIC INGREDIENTS NO Artificial Drugs or Chemicals #1 Oral Germ Killer Instant Pain Relief CUROXEN® ORAL CARE A Homeopathic Medicine that provides pain relief, speeds healing, and helps prevent Infection in mouth sores Pain relief and treatment of: Canker sores Cheek bites Cold sores, and abrasions from braces & dentures Mouth Sore Treatment Pain Relief Healing Fights Infection NET WT 0.42 oz (11.9 g) Curoxen Oral Revised"
      ],
      "set_id": "60cc114f-f63b-60f6-e053-2a91aa0acd53",
      "id": "419b403c-ddbf-7e14-e063-6394a90a1a90",
      "effective_time": "20251020",
      "version": "7",
      "openfda": {
        "brand_name": [
          "Curoxen Oral Care"
        ],
        "generic_name": [
          "OLIVE EXTRACT, CALENDULA, CLOVE OIL"
        ],
        "manufacturer_name": [
          "OrganiCare Nature's Science, LLC"
        ],
        "product_ndc": [
          "71042-004"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CLOVE OIL",
          "OLEA EUROPAEA FRUIT VOLATILE OIL",
          "CALENDULA OFFICINALIS FLOWERING TOP"
        ],
        "spl_id": [
          "419b403c-ddbf-7e14-e063-6394a90a1a90"
        ],
        "spl_set_id": [
          "60cc114f-f63b-60f6-e053-2a91aa0acd53"
        ],
        "package_ndc": [
          "71042-004-12"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "578389D6D0",
          "8E7358CX1J",
          "18E7415PXQ"
        ]
      }
    }
  ]
}