{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Care One Maximum Strength Fluoride WATER SACCHARIN SODIUM SODIUM TRIPOLYPHOSPHATE POLYETHYLENE GLYCOL 400 SORBITOL TITANIUM DIOXIDE SODIUM HYDROXIDE GLYCERIN XANTHAN GUM HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION mint"
      ],
      "active_ingredient": [
        "Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Antihypersensitivity Anticavity"
      ],
      "indications_and_usage": [
        "Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact aids in the prevention oif dental cavities"
      ],
      "warnings": [
        "Warnings When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product do not use longer than 4 weeks unless recommended by a dentist or physician."
      ],
      "stop_use": [
        "See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children . If more than used for brushing is accidentally swallowed, 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 one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: consult a dentist or physician."
      ],
      "inactive_ingredient": [
        "Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum"
      ],
      "storage_and_handling": [
        "Store in a cool, dry place. Keep tube capped when not in use."
      ],
      "spl_unclassified_section": [
        "DISTRIBUTED BY: American Sales Company 4201 Walden Avenue Lancaster, NY 14086"
      ],
      "package_label_principal_display_panel": [
        "Carton R9"
      ],
      "set_id": "24715cc7-cf02-4ea0-a491-2a111ad3660e",
      "id": "439584ef-226b-fedb-e063-6394a90aaffd",
      "effective_time": "20251114",
      "version": "10",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Care One Maximum Strength"
        ],
        "generic_name": [
          "FLUORIDE"
        ],
        "manufacturer_name": [
          "American Sales"
        ],
        "product_ndc": [
          "41520-582"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE",
          "POTASSIUM NITRATE"
        ],
        "rxcui": [
          "1038929"
        ],
        "spl_id": [
          "439584ef-226b-fedb-e063-6394a90aaffd"
        ],
        "spl_set_id": [
          "24715cc7-cf02-4ea0-a491-2a111ad3660e"
        ],
        "package_ndc": [
          "41520-582-12",
          "41520-582-19"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7",
          "RU45X2JN0Z"
        ]
      }
    }
  ]
}