{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Dentalclean Advanced Pro Sodium Fluoride 0.24% SODIUM FLUORIDE FLUORIDE ION MENTHOL SUCRALOSE CETYLPYRIDINIUM CHLORIDE ANHYDROUS SODIUM LAURYL SULFATE WATER SILICON DIOXIDE SORBITOL POTASSIUM CITRATE METHYL SALICYLATE GLYCERIN SODIUM BENZOATE TITANIUM DIOXIDE SODIUM PYROPHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED"
      ],
      "active_ingredient": [
        "Sodium fluoride 0.24%"
      ],
      "purpose": [
        "Anticavity"
      ],
      "indications_and_usage": [
        "Use • Aids in the prevention of cavities • Helps prevent gingivitis •Helps interfere with harmful effects of plaque associated with gingivitis • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact."
      ],
      "warnings": [
        "WARNINGS: When using this product for sensitivity , do not use longer than 4 weeks unless recommended by a dentist. Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a dentist if • gingivitis, bleeding, or redness persists for more than 2 weeks • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children"
      ],
      "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 bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth. Do not swallow. Children under 12 year of age: consult a dentist."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Silicon Dioxide, Glycerol, Sorbitol, Sodium Lauryl Sulphate, Potassium Citrate Monohydrate, Aroma, Carmellose Sodium, Titanium Dioxide, Tetrasodium Pyrophosphate, Menthol, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, Methyl Salicylate."
      ],
      "package_label_principal_display_panel": [
        "label label"
      ],
      "set_id": "4d261dc8-b065-567f-e063-6294a90aa93f",
      "id": "5aae5bcf-6f26-c44b-e063-6394a90afd94",
      "effective_time": "20260904",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Dentalclean Advanced Pro"
        ],
        "generic_name": [
          "SODIUM FLUORIDE 0.24%"
        ],
        "manufacturer_name": [
          "Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda"
        ],
        "product_ndc": [
          "84035-013"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "5aae5bcf-6f26-c44b-e063-6394a90afd94"
        ],
        "spl_set_id": [
          "4d261dc8-b065-567f-e063-6294a90aa93f"
        ],
        "package_ndc": [
          "84035-013-06",
          "84035-013-50"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}