{"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."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION 1. Remove cap from bottle by turning counter-clockwise. 2. Remove induction seal from bottle. DO NOT USE IF SEAL IS BROKEN. 3. Insert [enclosed] pump into bottle and tighten, turning clockwise. 4. Dispense premeasured [approximately 15 mL] fluoride rinse into cup [provided]. 5. Have patient rinse [swish] with fluoride rinse for 30 seconds. Expectorate. 6. Repeat steps 4 & 5. 7. Treatment is complete. 8. Instruct patient not to eat, drink, or rinse for 30 minutes. Recommended Frequency: Not to exceed four [4] treatments per year."],"effective_time":"20220118","how_supplied":["HOW SUPPLIED 2.0% sodium fluoride (0.9% fluoride ion) oral solution supplied in 63 Fl. oz (1863 ml bottles)"],"id":"77f1bd3b-7f25-4d36-af9f-60760bc699fd","indications_and_usage":["INDICATIONS AND USAGE For topical application to aid in the protection against dental caries. The non-acidic fluoride is safe for patients with porcelain, composite restorations, and sealants."],"openfda":{},"overdosage":["OVERDOSAGE If treatment dose is swallowed [less than 100 mg F], administer milk, limewater, or calcium-type antacid. In case of larger doses [1 pint contains 4.5 grams F ion, which is a lethal dose], use ipecac syrup emetic and immediately seek medical help."],"package_label_principal_display_panel":["PRICIPAL DISPLAY PANEL - Tropical Tropical bottle","PRINCIPAL DISPLAY PANEL - Mint Mint bottle","PRINCIPAL DISPLAY PANEL - Berry Cherry berry cherry bottle","PRINCIPAL DISPLAY PANEL - Peach Peach bottle"],"set_id":"615377b0-5682-1ba2-e053-2991aa0a096c","spl_product_data_elements":["Nupro Fluorides Tropical Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID XANTHAN GUM FD&C RED NO. 40 WATER FD&C YELLOW NO. 6 Tropical Nupro Fluorides Mint Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID XANTHAN GUM FD&C BLUE NO. 1 WATER Nupro Fluorides Berry Cherry Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID XANTHAN GUM FD&C RED NO. 40 WATER Berry Cherry Nupro Fluorides Peach Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION FD&C YELLOW NO. 6 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID XANTHAN GUM FD&C RED NO. 40 WATER Peach"],"spl_unclassified_section":["MANUFACTURED FOR Manufactured for: DENTSPLY Professional 1301 Smile Way • York, PA 17404 USA Toll Free: 800-989-8826 Made in the USA NRINSEDFU, R0-092017"],"storage_and_handling":["STORAGE Store at room temperature. Protect from freezing."],"version":"3","warnings_and_cautions":["WARNINGS AND PRECAUTIONS Do not swallow. Keep out of reach of children. May contain FD&C Yellow No. 6. Safety and effectiveness below age 3 have not been established. There have been no long-term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential."]}