{
  "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": "2026-10-02",
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      "spl_product_data_elements": [
        "Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION"
      ],
      "description": [
        "General Information AMD Medicom Inc. DentiCare Pro-Rinse 2% Neutral Sodium Fluoride Oral Rinse Mint 1.9 L / 64 fl oz NDC 64778-0446-1 NPN 80008542 Item code 10044-M"
      ],
      "indications_and_usage": [
        "Indications and Directions Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations. Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit, repeat the rinse procedure with an additional 10mL. Advise patient not to eat, drink or rinse for 30 minutes after application. Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls"
      ],
      "inactive_ingredient": [
        "Non-Medicinal Ingredients Citric acid, potassium sorbate, purified water, sorbitol, sucralose, blue 1, yellow 5, peppermint flavour, sodium hydroxide"
      ],
      "warnings_and_cautions": [
        "Warnings KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for use by children under 6 years of age. Do not swallow. Store at room temperature. Do not expose to excessive heat over 40ºC or 104ºF. Do not use if seal is broken."
      ],
      "spl_unclassified_section": [
        "Contact Information Rx Only in US Made in USA for AMD Medicom Inc. 2555 Chemin de l’Aviation, Pointe-Claire, Quebec, Canada H9P 2Z2 Questions: 1-800-361-2862 www.medicom.com"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel DentiCare Pro-Rinse 2% Neutral Sodium Fluoride Oral Rinse"
      ],
      "set_id": "1da64824-9389-4109-bea9-b91600caf023",
      "id": "4c4b0fd6-ca08-179a-e063-6394a90a6628",
      "effective_time": "20260305",
      "version": "8",
      "openfda": {
        "brand_name": [
          "Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "AMD Medicom"
        ],
        "product_ndc": [
          "64778-0446"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "251960",
          "991007"
        ],
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        "package_ndc": [
          "64778-0446-1",
          "64778-0446-3"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
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    }
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}