{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "ACT Anticavity Fluoride Arctic Blast sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL POLOXAMER 407 PROPYLENE GLYCOL MENTHOL METHYL SALICYLATE SODIUM PHOSPHATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POTASSIUM SORBATE POLYSORBATE 20 SACCHARIN SODIUM CETYLPYRIDINIUM CHLORIDE EDETATE CALCIUM DISODIUM ANHYDROUS SODIUM BENZOATE FD&C BLUE NO. 1"
      ],
      "spl_unclassified_section": [
        "ACT ® Anticavity™ Fluoride Rinse Arctic Blast Drug Facts",
        "Other information do not use if safety seal is broken or missing"
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warnings 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 of age and older: use once a day after brushing your teeth with a toothpaste remove cap hold bottle upright and squeeze. FILL to FILL LINE (10 mL) vigorously swish 10 milliliters 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 water, sorbitol, poloxamer 407, propylene glycol, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, blue 1"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL ZERO ALCOHOL ACT 1X Daily ANTICAVITY ARCTIC BLAST 18 fl oz (532 mL) PRINCIPAL DISPLAY PANEL ZERO ALCOHOL ACT 1X Daily ANTICAVITY ARCTIC BLAST 18 fl oz (532 mL) PRINCIPAL DISPLAY PANEL ZERO ALCOHOL ACT 1X Daily ANTICAVITY ARCTIC BLAST 18 fl oz (532 mL)"
      ],
      "set_id": "2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c57",
      "id": "36e783b7-17fc-4f04-a208-8b5f673041a9",
      "effective_time": "20240822",
      "version": "4",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "ACT Anticavity Fluoride Arctic Blast"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Chattem, Inc."
        ],
        "product_ndc": [
          "41167-0937"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "240698",
          "656809"
        ],
        "spl_id": [
          "36e783b7-17fc-4f04-a208-8b5f673041a9"
        ],
        "spl_set_id": [
          "2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c57"
        ],
        "package_ndc": [
          "41167-0937-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}