{
  "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,
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    }
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  "results": [
    {
      "spl_product_data_elements": [
        "Eurofresh Whitening SODIUM FLUORIDE CALCIUM CARBONATE SORBITOL WATER HYDRATED SILICA LAURYL GLUCOSIDE XANTHAN GUM TITANIUM DIOXIDE SODIUM BENZOATE SACCHARIN SODIUM TEA TREE OIL ASIAN GINSENG ALOE VERA LEAF SALVADORA PERSICA ROOT SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS Sodium Fluoride - 0.24% PURPOSE Anticavity"
      ],
      "purpose": [
        "PURPOSE Anticavity"
      ],
      "indications_and_usage": [
        "USE Helps protect against cavities Helps whiten teeth"
      ],
      "warnings": [
        "WARNINGS Do not use if irritation occurs and persists. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use if irritation occurs and persists."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "DIRECTION Supervise children as necessary until capable of using without supervision. Do not swallow. Rinse away toothpaste residue thoroughly after brushing. Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years: ask a dentist or physician."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Calcium Carbonate, Sorbitol, Water/Aqua, Hydrated Silica, Lauryl Glucoside, Xanthan Gum, Flavour/Aroma, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tea Tree Oil/Melaleuca alternifolia Leaf Oil, Panax Ginseng Root Extract, aloe Juice Barbadensis Leaf juice, Salvadora Persica Bark/Root Extract."
      ],
      "questions": [
        "Questions or Comments? info@farmasius.com 1786 236 7338 Monday - Friday (9 a.m-6 p.m. EST)"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label Label2"
      ],
      "set_id": "b56b2b55-e3a4-785a-e053-2a95a90a7abf",
      "id": "0973365b-3496-8024-e063-6294a90a60c8",
      "effective_time": "20231105",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Eurofresh Whitening"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Farmasi US LLC"
        ],
        "product_ndc": [
          "74690-008"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "0973365b-3496-8024-e063-6294a90a60c8"
        ],
        "spl_set_id": [
          "b56b2b55-e3a4-785a-e053-2a95a90a7abf"
        ],
        "package_ndc": [
          "74690-008-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}