{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "PRO-SYS Sensitivity - Mint (OTC) CELLULOSE GUM TITANIUM DIOXIDE SODIUM LAURYL SULFATE SORBITOL HYDRATED SILICA PEG-12 GLYCERIN DISODIUM PHOSPHATE SODIUM SACCHARIN WATER SODIUM BENZOATE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active Ingredient Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion) Potassium Nitrate 5%"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Titanium Dioxide, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin"
      ],
      "purpose": [
        "Purpose Anticavity Toothpaste"
      ],
      "indications_and_usage": [
        "Uses Helps protect against cavities"
      ],
      "warnings": [
        "Warnings Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult a dentist or doctor."
      ],
      "questions": [
        "Questions or Comments? For more information on the entire family of PRO-SYS oral care products, visit www.PRO-SYS.com. 1-800-462-3626"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel PRO-SYS® PROFESSIONAL ANTI-CAVITY FLUORIDE TOOTHPASTE SENSITIVE MINT, 0.85 OZ. (24G) BENCO DENTAL PRO-SYS® PROFESSIONAL ANTI-CAVITY FLUORIDE TOOTHPASTE SENSITIVE MINT, 4.0 OZ. (113G) BENCO DENTAL Tube1 Tube2"
      ],
      "set_id": "4e46847e-8c1d-c988-e063-6394a90a8e50",
      "id": "500d7c21-dc0f-a18a-e063-6394a90ab3ee",
      "effective_time": "20260422",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "PRO-SYS"
        ],
        "generic_name": [
          "SENSITIVITY - MINT (OTC)"
        ],
        "manufacturer_name": [
          "Benco Dental"
        ],
        "product_ndc": [
          "66975-780"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL",
          "ORAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "500d7c21-dc0f-a18a-e063-6394a90ab3ee"
        ],
        "spl_set_id": [
          "4e46847e-8c1d-c988-e063-6394a90a8e50"
        ],
        "package_ndc": [
          "66975-780-01",
          "66975-780-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}