{"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."],"contraindications":["Contraindications: Hypersensitivity to fluoride."],"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"],"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."],"effective_time":"20251104","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."],"id":"42c899b3-99ed-0863-e063-6394a90ad112","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."],"openfda":{"brand_name":["Alpha-Pro"],"generic_name":["SODIUM FLUORIDE AND HYDROFLUORIC ACID"],"is_original_packager":[true],"manufacturer_name":["Dental Technologies, Inc."],"package_ndc":["55346-0943-1"],"product_ndc":["55346-0943"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["DENTAL"],"rxcui":["1297381"],"spl_id":["42c899b3-99ed-0863-e063-6394a90ad112"],"spl_set_id":["a86ec65f-f6e1-474d-aeff-412a4716a92c"],"substance_name":["SODIUM FLUORIDE","HYDROFLUORIC ACID"],"unii":["8ZYQ1474W7","RGL5YE86CZ"]},"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"],"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."],"set_id":"a86ec65f-f6e1-474d-aeff-412a4716a92c","spl_product_data_elements":["Alpha-Pro Sodium Fluoride and Hydrofluoric Acid SODIUM FLUORIDE FLUORIDE ION HYDROFLUORIC ACID FLUORIDE ION Vanilla Orange"],"version":"3","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."]}