{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 13
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Dentalclean Ultra Refreshing Extreme Ice Dental Gel Sodium Fluoride 0.24% SUCRALOSE CETYLPYRIDINIUM CHLORIDE ANHYDROUS WATER HYDRATED SILICA SORBITOL SODIUM LAURYL SULFATE MENTHOL CARBOXYMETHYLCELLULOSE GLYCERIN SODIUM BENZOATE SODIUM FLUORIDE FLUORIDE ION FD&C BLUE NO. 1"
      ],
      "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 Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor"
      ],
      "inactive_ingredient": [
        "Water, Glycerol, Silium Dioxide, Sorbitol, Sodium Lauryl Sulphate, Carmelose Sodium, Aroma, Menthol, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, Bright Blue (CI42090)"
      ],
      "other_safety_information": [
        "Store in a dry, cool place away from sunlight."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children"
      ],
      "package_label_principal_display_panel": [
        "label"
      ],
      "set_id": "1496636d-6563-d474-e063-6394a90ab73d",
      "id": "1496636d-6564-d474-e063-6394a90ab73d",
      "effective_time": "20240326",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Dentalclean Ultra Refreshing Extreme Ice Dental Gel"
        ],
        "generic_name": [
          "SODIUM FLUORIDE 0.24%"
        ],
        "manufacturer_name": [
          "Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda"
        ],
        "product_ndc": [
          "84035-001"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "1496636d-6564-d474-e063-6394a90ab73d"
        ],
        "spl_set_id": [
          "1496636d-6563-d474-e063-6394a90ab73d"
        ],
        "package_ndc": [
          "84035-001-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}