{
  "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": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Alcohol-Free Anticavity Sodium fluoride GLYCERIN CETYLPYRIDINIUM CHLORIDE CINNAMALDEHYDE SACCHARIN SODIUM PHOSPHORIC ACID SODIUM BENZOATE SUCRALOSE POLOXAMER 407 BENZOIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PROPYLENE GLYCOL D&C RED NO. 33 WATER FD&C GREEN NO. 3 SODIUM FLUORIDE FLUORIDE ION"
      ],
      "other_safety_information": [
        "TEP SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION"
      ],
      "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": [
        "Warnings for this product"
      ],
      "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 twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) 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, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3"
      ],
      "spl_unclassified_section": [
        "Disclaimer This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence. *This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ® Pro-Health ® Advanced Anticavity Flouride Mouthwash Enamel Care Alcohol Free. **This product is not intended to replace brushing or flossing."
      ],
      "adverse_reactions": [
        "Adverse reaction DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872 Quality guaranteed or your money back."
      ],
      "package_label_principal_display_panel": [
        "Principal display panel CAREONE ® Compare to the Active Ingredient in Crest ® Pro-Health ® Advanced Anticavity Fluoride Mouthwash* ALCOHOL FREE FLUORIDE MOUTHWASH ANTICAVITY FLUORIDE RINSE VIOLET MINT FLAVOR KILLS BAD BREATH GERMS HELPS PREVENT CAVITIES HELPS STRENGTHEN ENAMEL CLEANS TEETH** FRESHENS BREATH IMPORTANT: Read directions for proper use 33.8 FL OZ (1.05 QT) 1L image description image description"
      ],
      "set_id": "542e067a-c134-44c9-b962-f2a2b667b76f",
      "id": "4a2bad30-e7d2-c48a-e063-6294a90a5f47",
      "effective_time": "20260206",
      "version": "20",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Alcohol-Free Anticavity"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Retail Business Services, LLC"
        ],
        "product_ndc": [
          "72476-482"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "313029"
        ],
        "spl_id": [
          "4a2bad30-e7d2-c48a-e063-6294a90a5f47"
        ],
        "spl_set_id": [
          "542e067a-c134-44c9-b962-f2a2b667b76f"
        ],
        "package_ndc": [
          "72476-482-86"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}