{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Dentalclean Whitening Max Sodium Fluoride 0.24% MENTHOL SUCRALOSE CETYLPYRIDINIUM CHLORIDE ANHYDROUS SODIUM LAURYL SULFATE WATER SILICON DIOXIDE SORBITOL POTASSIUM CITRATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM GLYCERIN SODIUM BENZOATE SODIUM FLUORIDE FLUORIDE ION TITANIUM DIOXIDE SODIUM PYROPHOSPHATE LIMONENE, (+/-)-"
      ],
      "active_ingredient": [
        "Sodium fluoride 0.24%"
      ],
      "purpose": [
        "Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental cavities"
      ],
      "warnings": [
        "WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. • Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision. • Children under 2 years of age: do not use unless directed by a dentist or doctor or as directed by a dentist or doctor."
      ],
      "other_safety_information": [
        "Store in a dry, cool place away from sunlight."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Glycerin, Silium Dioxide, Water, Sodium Lauryl Sulphate, Monohydrate Potassium Citrate, Sorbitol, Aroma, Carmetlose Sodium, Tetrasodium Pyrophosphate, Menthol, Cetytpyridinium Chloride, Sodium Benzoate, Titanium Dioxide, Sucralose, D-Limonene."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age"
      ],
      "package_label_principal_display_panel": [
        "Pack label"
      ],
      "set_id": "17e2364e-2511-3021-e063-6294a90a40e1",
      "id": "17e234b1-5dc0-ef03-e063-6294a90ae82c",
      "effective_time": "20240507",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Dentalclean Whitening Max"
        ],
        "generic_name": [
          "SODIUM FLUORIDE 0.24%"
        ],
        "manufacturer_name": [
          "Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda"
        ],
        "product_ndc": [
          "84035-004"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "17e234b1-5dc0-ef03-e063-6294a90ae82c"
        ],
        "spl_set_id": [
          "17e2364e-2511-3021-e063-6294a90a40e1"
        ],
        "package_ndc": [
          "84035-004-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}