{
  "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": "2026-10-29",
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  "results": [
    {
      "spl_product_data_elements": [
        "kids kare Stannous Fluoride CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) GLYCERIN TROLAMINE BERRY ANHYDROUS CITRIC ACID ASCORBIC ACID STANNOUS FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active ingredient Stannous Fluoride 0.4% (0.12% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Uses Aids in the prevention of dental cavities."
      ],
      "warnings": [
        "Warnings This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using."
      ],
      "when_using": [
        "When using this product it may produce surface staining of the teeth, Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the get to your teeth and brush thoroghly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor."
      ],
      "other_safety_information": [
        "Other information Do not use if the foil seal under the cap is torn, cut or missing."
      ],
      "inactive_ingredient": [
        "inactive ingredient Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine"
      ],
      "questions": [
        "Questions or comments? 1-800-752-2564"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel kids kare™ Preventative Treatment 0.4% Stannous Fluoride Brush-On Gel BERRY FLAVOR IMPORTANT: Read directions carefully Net Wt. 4.3 oz. (121.9 g) Kids Kare stannous gel"
      ],
      "set_id": "66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91",
      "id": "2a998081-6425-8228-e063-6294a90adc3d",
      "effective_time": "20241231",
      "version": "4",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "kids kare"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "DEN-MAT HOLDINGS, LLC."
        ],
        "product_ndc": [
          "59883-404"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL",
          "ORAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "spl_id": [
          "2a998081-6425-8228-e063-6294a90adc3d"
        ],
        "spl_set_id": [
          "66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91"
        ],
        "package_ndc": [
          "59883-404-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}