{
  "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": "2026-06-02",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Alpha-Pro Sodium Fluoride and Hydrofluoric Acid SODIUM FLUORIDE FLUORIDE ION HYDROFLUORIC ACID FLUORIDE ION Vanilla Orange"
      ],
      "indications_and_usage": [
        "Indications and Usage: Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times per year."
      ],
      "contraindications": [
        "Contraindications: Hypersensitivity to fluoride."
      ],
      "warnings": [
        "Warning: Keep out of reach of children. Do not swallow. If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. Contains FD&C Yellow No.6."
      ],
      "precautions": [
        "Precautions: For professional use only. This product is not intended for home or unsupervised consumer use. Repeated use may cause dulling of porcelain and ceramic restorations."
      ],
      "adverse_reactions": [
        "Adverse Reactions: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness."
      ],
      "dosage_and_administration": [
        "Dosage and Administration: After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes."
      ],
      "how_supplied": [
        "How Supplied: A gel, one bottle contains up to 68 individual applications. Store at controlled room temperature 20°- 25°C (68°-77°F). Do not allow to freeze."
      ],
      "description": [
        "Active Ingredients: 1.23% w/w Fluoride Ion (0.79% from Sodium Fluoride and 0.44% from Hydrogen Fluoride) in 0.1 Molar Phosphoric Acid. DENTAL TECHNOLOGIES LINCOLNWOOD, ILLINOIS 60712 USA www.dentaltech.com Questions or Comments? Call: 1-800-835-0885 (US) or 1-847-677-5500 PM-5098 Rev002"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel DENTAL TECHNOLOGIES www.dentaltech.com ALPHA-PRO® APF TOPICAL GEL 60 SECOND TREATMENT Acidulated Phosphate Fluoirde 1.23% Fluoride Ion Rx Only Vanilla Orange REF No. 009-4301-002 NET WEIGHT: 17.5 oz. (497g) APF_Orange"
      ],
      "set_id": "a86ec65f-f6e1-474d-aeff-412a4716a92c",
      "id": "42c899b3-99ed-0863-e063-6394a90ad112",
      "effective_time": "20251104",
      "version": "3",
      "openfda": {
        "brand_name": [
          "Alpha-Pro"
        ],
        "generic_name": [
          "SODIUM FLUORIDE AND HYDROFLUORIC ACID"
        ],
        "manufacturer_name": [
          "Dental Technologies, Inc."
        ],
        "product_ndc": [
          "55346-0943"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "HYDROFLUORIC ACID",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1297381"
        ],
        "spl_id": [
          "42c899b3-99ed-0863-e063-6394a90ad112"
        ],
        "spl_set_id": [
          "a86ec65f-f6e1-474d-aeff-412a4716a92c"
        ],
        "package_ndc": [
          "55346-0943-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RGL5YE86CZ",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}