{"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":"d70c50cf-7e92-15be-e053-2a95a90a0713","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":["66975-050-15"],"product_ndc":["66975-050"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["DENTAL"],"rxcui":["245593"],"spl_id":["d70c50cf-7e92-15be-e053-2a95a90a0713"],"spl_set_id":["5fa57e34-5827-4d37-a5dc-965750e5be50"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["Benco_APF_bubble.jpg"],"set_id":"5fa57e34-5827-4d37-a5dc-965750e5be50","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"],"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":"5","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."]}