{"dosage_and_administration":["Dosage and administration: Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year. 1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). 3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes."],"effective_time":"20220120","id":"d604cf11-7991-e39b-e053-2a95a90acc87","inactive_ingredient":["Inactive ingredients: Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xantham Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive."],"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":["Gelato APF"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc."],"package_ndc":["68400-122-15"],"product_ndc":["68400-122"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["DENTAL"],"rxcui":["245593","656838"],"spl_id":["d604cf11-7991-e39b-e053-2a95a90acc87"],"spl_set_id":["a857af18-8eb8-47dc-bb26-73a321ed643c"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["LB.Gelato APF Gel_generic_R2.jpg"],"set_id":"a857af18-8eb8-47dc-bb26-73a321ed643c","spl_product_data_elements":["Gelato 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 BLUE NO. 1 FD&C GREEN NO. 3 FD&C RED NO. 3 FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 SODIUM FLUORIDE FLUORIDE ION Mango Smoothie"],"spl_unclassified_section":["Active ingredient: Purpose: Fluoride Ion 1.23% ...........................Fluoride Treatment Gel Available from 2.09% Sodium Fluoride and Hydrofluoric Acid."],"storage_and_handling":["Other information: • Do not store above 25°C/77°F. Do not freeze."],"version":"6","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."]}