{
  "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": [
        "CURODONT PROTECT STANNOUS FLUORIDE SORBITOL SODIUM HYDROXIDE WATER HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE SODIUM GLUCONATE OLIGOPEPTIDE 104 XYLITOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED PHOSPHORIC ACID STANNOUS FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS STANNOUS FLUORIDE 0.454% (0.14% W/V FLUORIDE ION)"
      ],
      "purpose": [
        "PURPOSE ANTICAVITY AND ANTISENSITIVITY"
      ],
      "indications_and_usage": [
        "USE AIDS IN THE PREVENTION OF DENTAL CAVITIES AND BUILDS INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH."
      ],
      "warnings": [
        "WARNINGS Stop use and ask a doctor if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use."
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN. IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY."
      ],
      "dosage_and_administration": [
        "DIRECTIONS Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor."
      ],
      "other_safety_information": [
        "OTHER INFORMATION This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Sorbitol, Water, Hydrated Silica, Sodium Tripolyphosphate, Sodium Gluconate, Xylitol, Cellulose Gum, Oligopeptide-104, Sodium Hydroxide, Phosphoric Acid."
      ],
      "package_label_principal_display_panel": [
        "PDP DF"
      ],
      "set_id": "03ec591c-68c3-a380-e063-6394a90a131a",
      "id": "284225ec-2b67-6ed5-e063-6294a90a89df",
      "effective_time": "20241201",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "CURODONT PROTECT"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "CREDENTIS AG"
        ],
        "product_ndc": [
          "72247-107"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "284225ec-2b67-6ed5-e063-6294a90a89df"
        ],
        "spl_set_id": [
          "03ec591c-68c3-a380-e063-6394a90a131a"
        ],
        "package_ndc": [
          "72247-107-13",
          "72247-107-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}