{"dosage_and_administration":["Dosage and Administration: Shake well before use. This is a 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 four minutes. 3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes."],"effective_time":"20240422","id":"16b24df6-2bec-a706-e063-6294a90a5fba","inactive_ingredient":["Inactive Ingredients: Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan 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 Use Only. This product is not intended for home or unsupervised consumer use."],"openfda":{"brand_name":["Gelato Neutral pH"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc"],"package_ndc":["68400-136-15"],"product_ndc":["68400-136"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["DENTAL"],"rxcui":["245593","656838"],"spl_id":["16b24df6-2bec-a706-e063-6294a90a5fba"],"spl_set_id":["2f8fe488-4a1b-451a-852b-4ddc2cf08347"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["LB.Gelato Neutral PH Sodium Fluoride Gel.jpg"],"set_id":"2f8fe488-4a1b-451a-852b-4ddc2cf08347","spl_product_data_elements":["Gelato Neutral pH Sodium Fluoride CITRIC ACID MONOHYDRATE MAGNESIUM ALUMINUM SILICATE PHOSPHORIC ACID POLYSORBATE 20 POTASSIUM HYDROXIDE 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 Dye Free"],"spl_unclassified_section":["Active Ingredient: Sodium Fluoride 2%","Purpose: Fluoride Treatment Gel"],"storage_and_handling":["Other Infomation: • Do not store above 25°C/77°F. Do not freeze."],"version":"12","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."]}