{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Synedent FLX Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER"
      ],
      "spl_unclassified_section": [
        "Drug Facts Active Ingredients Sodium fluoride 0.05% (0.02% fluoride ion) Purpose Anticavity Use Aids in the prevention of dental cavities Warnings Keep out of reach of children. If more than indicated is swallowed, get medical attention or contact a Poison Control Center right away. Contains shellfish derivatives. Not to be used by pets. Do not use if safety seal is broken or missing. Directions Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor. Other Information Store at room temperature. Inactive Ingredients Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide Question? Call toll-free 855-774-7962"
      ],
      "active_ingredient": [
        "Active Ingredients Sodium fluoride 0.05% (0.02% w/v fluoride ion)"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children Keep out of reach of children"
      ],
      "warnings": [
        "Warnings If more than indicates is swallowed, get medical attention or contact Poison Control Center right away. Contains shellfish derivatives. Not to be used by pets. Do not use if safety seal is broken or missing."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use Aids in the prevention of dental cavities"
      ],
      "package_label_principal_display_panel": [
        "Labels Label Front Label Middle Label Base"
      ],
      "set_id": "a011ed68-86a0-5e59-e053-2995a90acedf",
      "id": "a0201a4f-b41c-2c1d-e053-2995a90a9d62",
      "effective_time": "20200305",
      "version": "2",
      "openfda": {}
    }
  ]
}