{"dosage_and_administration":["Dosage and administration: Shake well before use. This is a one minute of four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year. • After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. • Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). • Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes."],"effective_time":"20220202","id":"d70c8143-4a70-9538-e053-2a95a90a059c","inactive_ingredient":["Inactive Ingredients: Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol"],"indications_and_usage":["Indications and usage: • A stable thixotropic fluoride treatment gel used to help prevent dental decay. • For Professional Office Use Only. This product is not intended for home or unsupervised consumer use."],"openfda":{"brand_name":["Iris 60 Second APF"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Benco Dental"],"package_ndc":["66975-054-15"],"product_ndc":["66975-054"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["DENTAL"],"rxcui":["245593"],"spl_id":["d70c8143-4a70-9538-e053-2a95a90a059c"],"spl_set_id":["d5658bf8-3a13-4d8b-b727-5f1575919571"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["Benco_APF_straw.jpg"],"set_id":"d5658bf8-3a13-4d8b-b727-5f1575919571","spl_product_data_elements":["Iris 60 Second APF Sodium Fluoride CITRIC ACID MONOHYDRATE MAGNESIUM ALUMINUM SILICATE PHOSPHORIC ACID POLYSORBATE 20 SODIUM BENZOATE SACCHARIN SODIUM TITANIUM DIOXIDE WATER XANTHAN GUM XYLITOL FD&C RED NO. 40 SODIUM FLUORIDE FLUORIDE ION Summer Strawberry"],"spl_unclassified_section":["Active Ingredients: 1.23% Fluoride Ion Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.","Purpose: Fluoride Treatment Gel"],"storage_and_handling":["Other information: Do not store above 25°C/77°F. Do not freeze."],"version":"3","warnings":["Warnings: • Keep out of reach of children. • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away. • Read directions carefully before using."]}