{"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, remove induction seal. DO NOT USE IF SEAL IS BROKEN. 2. Replace cap and shake well. 3. Dispense a narrow ribbon of gel into applicator trays. 4. Air dry teeth thoroughly and insert trays in mouth with head tilted slightly forward. 5. Instruct patient to continue light biting action for 1 minute (or up to 4 minutes). A slight chewing motion enhances interproximal coverage. 6. Use suction throughout treatment. 7. Have patient expectorate after treatment. 8. Instruct patient not to eat, drink, or rinse for 30 minutes. Recommended Frequency: Not to exceed four 4 treatments per year."],"effective_time":"20220124","how_supplied":["HOW SUPPLIED 2.59% sodium fluoride (1.23% fluoride ion) gel supplied in 12 fl. oz. bottles."],"id":"43c5ec5b-ea38-49f3-a473-7dc8b6c232c9","indications_and_usage":["INDICATIONS AND USAGE For topical application to aid in the protection against dental caries."],"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":["PRINCIPAL DISPLAY PANEL - Wild Cherry wild cherry","PRICIPAL DISPLAY PANEL - Bubble Gum bubble gum"],"set_id":"6154542f-4ea4-7155-e053-2991aa0ad998","spl_product_data_elements":["Nupro Fluorides Wild Cherry Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION HYDROFLUORIC ACID METHYLPARABEN CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) PHOSPHORIC ACID BENZOIC ACID FD&C RED NO. 40 WATER XANTHAN GUM SACCHARIN SODIUM Wild Cherry Nupro Fluorides Bubble Gum Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION HYDROFLUORIC ACID METHYLPARABEN CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) PHOSPHORIC ACID BENZOIC ACID FD&C RED NO. 40 WATER XANTHAN GUM SACCHARIN SODIUM"],"spl_unclassified_section":["SDS WARNINGS SAFETY DATA SHEET is available on our website, www.dentsplysirona.com, or by contacting Customer Service at 1-800-989-8826. SDS warning","MANUFACTURED FOR Manufactured For: DENTSPLY Professional 1301 Smile Way York, PA 17404 USA 1-800-989-8826 Made in the U.S.A"],"storage_and_handling":["STORAGE Store at room temperature. Protect from freezing."],"version":"5","warnings_and_cautions":["WARNINGS AND PRECAUTIONS Do not swallow. Keep out of reach of children. 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. Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants."]}