{"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, urticarial, gastric distress, headache, and weakness."],"contraindications":["Contraindications Hypersensitivity to fluoride. Do not use if patient has a known allergy to fluoride or any of the other ingredients in this product."],"description":["Description Topex® Fluoride Gels are a family of topical fluoride gel products for professional application in trays."],"dosage_and_administration":["Dosage & Administration 1. DO NOT USE IF SEAL IS BROKEN. Shake well before using. 2. Fill applicator tray no more than 1/3 full with Fluoride gel. 3. Dry tooth surface and insert tray in mouth. 4. Use suction throughout treatment. 5. Have patient bite down for a minimum of 60 seconds to a maximum of 4 minutes. (A slight biting or chewing motion will provide interproximal coverage) 6. Remove tray and have patient expectorate excess gel. Do not swallow. 7. Instruct patient not to eat, drink, or rinse for 30 minutes after treatment."],"dosage_forms_and_strengths":["Dosage Forms & Strengths This topical gel contains 1.23% sodium fluoride ion."],"effective_time":"20220118","id":"3b8e901d-a029-4dfb-9329-80c8610eb145","indications_and_usage":["Indications & Usage For topical application to aid in the prevention of dental caries. Treatment frequency should not exceed 4 treatments per year."],"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 - Cherry Cherry label","Principal Display Label - Mint Mint Label","Principal Display Label - Orange Cream Orange Label"],"set_id":"59039cf6-9007-7367-e053-2a91aa0a2fe9","spl_product_data_elements":["Topex 60 Second Fluoride Gel Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION MAGNESIUM ALUMINUM SILICATE POLYSORBATE 20 SACCHARIN SODIUM ANHYDROUS CITRIC ACID XYLITOL SODIUM BENZOATE PHOSPHORIC ACID HYDROFLUORIC ACID TITANIUM DIOXIDE XANTHAN GUM WATER FD&C YELLOW NO. 6 TANGERINE Orange Cream Topex 60 Second Fluoride Gel Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION MAGNESIUM ALUMINUM SILICATE POLYSORBATE 20 SACCHARIN SODIUM ANHYDROUS CITRIC ACID XYLITOL SODIUM BENZOATE PHOSPHORIC ACID HYDROFLUORIC ACID WATER FD&C RED NO. 40 TITANIUM DIOXIDE XANTHAN GUM Topex 60 Second Fluoride Gel Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION MAGNESIUM ALUMINUM SILICATE POLYSORBATE 20 SACCHARIN SODIUM ANHYDROUS CITRIC ACID XYLITOL SODIUM BENZOATE PHOSPHORIC ACID HYDROFLUORIC ACID FD&C BLUE NO. 1 TITANIUM DIOXIDE XANTHAN GUM WATER FD&C YELLOW NO. 5 SPEARMINT"],"storage_and_handling":["Storage Store between 68° - 77°F (20° - 25°C). Do not allow to freeze."],"version":"2","warnings_and_cautions":["Warnings & Precautions Do not swallow. Harmful if swallowed. Keep out of reach of children. May contain FD&C Yellow #5 or FD&C Yellow #6. This product is not intended for home or unsupervised consumer use. 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."]}