{
  "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": [
        "CVS Pharmacy Pro Defense Fluoride GLYCERIN SACCHARIN SODIUM WATER SODIUM TRIPOLYPHOSPHATE ANHYDROUS TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM LAURYL SULFATE STANNOUS FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active ingredient Stannous Fluoride (0.454% w/w)"
      ],
      "purpose": [
        "Purpose Anticavity/Antigingiviitis"
      ],
      "indications_and_usage": [
        "Uses aids in the prevention of dental cavities helps control bleeding gums helps interfere with harmful effects of plaque associated with gingivitis"
      ],
      "warnings": [
        "Warnings When using this product, discontinue use if irritation occurs. Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be signs or symptoms of periodontis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product, discontinue use if irritation occurs."
      ],
      "stop_use": [
        "Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be signs or symptoms of periodontis, a serious form of gum disease."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day and not more than 3 times a day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 years of age: consult a dentist or doctor"
      ],
      "other_safety_information": [
        "Other information products containing Stannous Fluoride may cause 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. This product is specially formulated to help prevent staining. Store below 77F (25C) Keep tube capped when not in use."
      ],
      "inactive_ingredient": [
        "Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, cellulose gum, cocamidopropyl betaine, titanium dioxide, sodium lauryl sulfate, flavor, sodium saccharin"
      ],
      "spl_unclassified_section": [
        "Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 ©2017 CVS/pharmacy CVS.com 1-800-SHOP CVS"
      ],
      "package_label_principal_display_panel": [
        "Carton Label"
      ],
      "set_id": "445ec57e-dc3c-49a0-8ca9-4806fcdc0303",
      "id": "47e6024c-0157-bf83-e063-6294a90a94cf",
      "effective_time": "20260108",
      "version": "10",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "CVS Pharmacy Pro Defense"
        ],
        "generic_name": [
          "FLUORIDE"
        ],
        "manufacturer_name": [
          "CVS Pharmacy"
        ],
        "product_ndc": [
          "69842-872"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "47e6024c-0157-bf83-e063-6294a90a94cf"
        ],
        "spl_set_id": [
          "445ec57e-dc3c-49a0-8ca9-4806fcdc0303"
        ],
        "package_ndc": [
          "69842-872-19"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}