{
  "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",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Home Care Fluoride Stannous Fluoride ASCORBIC ACID ANHYDROUS CITRIC ACID GLYCERIN TROLAMINE STANNOUS FLUORIDE FLUORIDE ION CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) Strawberry"
      ],
      "active_ingredient": [
        "Active ingredient Stannous Fluoride 0.4% (0.12% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Uses Helps aid 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 gel to your teeth and brush thoroughly. 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 ingredients Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine"
      ],
      "questions": [
        "Questions or comments? 1.800.835.0885 or 847.677.5500"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel alpha-dent® HOME CARE FLUORIDE GEL 0.4% STANNOUS FLUORIDE AIDS IN THE PREVENTION OF DENTAL CAVITIES STRAWBERRY REF 004.0402.001 NET WEIGHT - 4.3 oz. (121.9g) DENTAL TECHNOLOGIES 6901 N HAMLIN AVENUE LINCOLNWOOD, ILLINOIS 60712 USA www.dentaltech.com Stannous_Strawberry_image.jpg"
      ],
      "set_id": "16ebcb37-5703-4e10-b965-570e18434b52",
      "id": "42c873be-f572-d9df-e063-6394a90a16b4",
      "effective_time": "20251104",
      "version": "12",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Home Care Fluoride"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "Dental Technologies, Inc."
        ],
        "product_ndc": [
          "55346-0404"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL",
          "ORAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "spl_id": [
          "42c873be-f572-d9df-e063-6394a90a16b4"
        ],
        "spl_set_id": [
          "16ebcb37-5703-4e10-b965-570e18434b52"
        ],
        "package_ndc": [
          "55346-0404-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}