{
  "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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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "PerCara Kids Bubble Gum Sodium fluoride BENZYL ALCOHOL EDETATE CALCIUM DISODIUM ANHYDROUS CETYLPYRIDINIUM CHLORIDE POLOXAMER 407 POLYSORBATE 80 PROPYLENE GLYCOL D&C RED NO. 33 SODIUM BENZOATE SODIUM PHOSPHATE SODIUM PHOSPHATE DIBASIC DIHYDRATE SACCHARIN SODIUM SORBITOL WATER SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information Store at room temperature",
        "Distributed by: LEC Custom Products, Inc, Missisauga, ON L5S 1B8 MADE IN CANADA"
      ],
      "active_ingredient": [
        "Active Ingredients Sodium fluoride 0.05% (Fluoride ion-0.0226%)"
      ],
      "purpose": [
        "Purpose Anticavity rinse"
      ],
      "indications_and_usage": [
        "Uses aids the prevention of dental cavities"
      ],
      "warnings": [
        "Warning Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions adults and children 6 years of age and older, use once a day after brushing your teeth with a toothpaste Remove cap Use approximately one tablespoon and rinse vigorously 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 supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene plycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water"
      ],
      "package_label_principal_display_panel": [
        "PERCARA™ ALCOHOL FREE CAVITY PROTECTION kids BUBBLE GUM FLUORIDE RINSE 18 FL OZ (532 ML) PERCARA - Kids BG Fluoride Rinse"
      ],
      "set_id": "be3a7272-acfb-7d14-e053-2995a90a9420",
      "id": "0eb3968a-ead0-c8c9-e063-6394a90a06e5",
      "effective_time": "20240101",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "PerCara Kids Bubble Gum"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "LEC Custom Products, Inc."
        ],
        "product_ndc": [
          "67933-0016"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "240698"
        ],
        "spl_id": [
          "0eb3968a-ead0-c8c9-e063-6394a90a06e5"
        ],
        "spl_set_id": [
          "be3a7272-acfb-7d14-e053-2995a90a9420"
        ],
        "package_ndc": [
          "67933-0016-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0839294002526"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}