{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Crest Braces Care Anticavity Fluoride Rinse Sodium Fluoride WATER BENZOIC ACID PHOSPHORIC ACID SODIUM BENZOATE POLYSORBATE 80 POLOXAMER 407 SUCRALOSE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PROPYLENE GLYCOL SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride 0.02% (0.01% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use Aids in 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 right away."
      ],
      "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 right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years & older: Use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 mL of rinse 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 (to minimize swallowing). 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 benzoic acid, disodium phosphate, flavor, phosphoric acid, poloxamer 407, polysorbate 80, propylene glycol, sodium benzoate, sucralose, water"
      ],
      "questions": [
        "Questions? 1-844-436-7026"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 475 mL Bottle Label Crest® BRACES CARE™ ANTICAVITY FLUORIDE RINSE mouthwash HELPS PROTECT AGAINST ENAMEL LOSS TO FIGHT CAVITIES FOR PEOPLE WHO WEAR BRACES AGES 6+ FRESH MINT 475 mL (16 FL OZ) Crest Braces Care Rinse"
      ],
      "set_id": "d8398cfd-9af6-690d-e053-2995a90a9b7c",
      "id": "49efe3bb-fc3b-3100-e063-6294a90a7bad",
      "effective_time": "20260203",
      "version": "8",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Crest Braces Care Anticavity Fluoride Rinse"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "The Procter & Gamble Manufacturing Company"
        ],
        "product_ndc": [
          "69423-881"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "313029"
        ],
        "spl_id": [
          "49efe3bb-fc3b-3100-e063-6294a90a7bad"
        ],
        "spl_set_id": [
          "d8398cfd-9af6-690d-e053-2995a90a9b7c"
        ],
        "package_ndc": [
          "69423-881-16"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}