{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "PRO-SYS Professional Sensitivity, SLS Free - Mint (5000 ppm) SODIUM FLUORIDE FLUORIDE ION XYLITOL SODIUM BENZOATE DISODIUM PHOSPHATE SODIUM SACCHARIN POTASSIUM NITRATE NITRATE ION HYDRATED SILICA TITANIUM DIOXIDE SORBITOL COCAMIDOPROPYL BETAINE GLYCERIN PEG-12 CELLULOSE GUM WATER"
      ],
      "indications_and_usage": [
        "Indications and Usage PRO-SYS Professional is a self-applied dentrifice for prevention of tooth decay, orthodontic decalcification and hypersensitivity."
      ],
      "warnings": [
        "Warnings • Do not swallow • For topical use only • As with all medications, keep out of reach of children"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Titanium Dioxide, Cocamidopropyl Betaine, Flavor, Cellulose Gum, Xylitol, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin"
      ],
      "dosage_and_administration": [
        "Directions: Use as Directed This prescription dentifrice is recommended for adults and pediatric patients six years and older. • Apply a thin ribbon of PRO-SYS Professional along the length of the toothbrush no more than \"pea size\" total dose. Brush for two minutes. • After brushing: ADULTS-Expectorate; do not eat or drink for 30 minutes. CHILDREN SIX YEARS OF AGE OR OLDER-Expectorate and rinse mouth with water. • Use at bedtime in place of your regular toothpaste or as directed by your dental professional."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel PRO-SYS® PROFESSIONAL ANTI-CAVITY FLUORIDE TOOTHPASTE RX ONLY 5000 PPM 1.1% SODIUM FLUORIDE 5% POTASSIUM NITRATE SENSITIVE MINT, 4 OZ. (113G) SODIUM LAURYL SULFATE FREE BENCO DENTAL Tube Box"
      ],
      "set_id": "4e4761d7-f1ab-aae4-e063-6294a90a214c",
      "id": "500d975b-b5ef-fc25-e063-6294a90a8377",
      "effective_time": "20251201",
      "version": "2",
      "openfda": {
        "brand_name": [
          "PRO-SYS"
        ],
        "generic_name": [
          "PROFESSIONAL SENSITIVITY, SLS FREE - MINT (5000 PPM)"
        ],
        "manufacturer_name": [
          "Benco Dental"
        ],
        "product_ndc": [
          "66975-779"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "637365"
        ],
        "spl_id": [
          "500d975b-b5ef-fc25-e063-6294a90a8377"
        ],
        "spl_set_id": [
          "4e4761d7-f1ab-aae4-e063-6294a90a214c"
        ],
        "package_ndc": [
          "66975-779-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}