{"effective_time":"20201116","id":"90fe60c1-b7dc-4162-9f56-25675460f2b3","inactive_ingredient":["Citric Acid, FD & C Red No. 40 (C.I. 16035), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan Gum, Xylitol"],"instructions_for_use":["Shake well before use. This is a four minute or one minute Fluoride gel for in-office patient use. For best results, use at least 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"],"openfda":{"brand_name":["Ionite APF"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Dharma Research, inc."],"package_ndc":["53045-203-17"],"product_ndc":["53045-203"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["DENTAL","ORAL"],"rxcui":["1535362"],"spl_id":["90fe60c1-b7dc-4162-9f56-25675460f2b3"],"spl_set_id":["e1797adf-4665-4322-a3aa-dd2da9dcd3a8"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["20200514_203_RevB"],"set_id":"e1797adf-4665-4322-a3aa-dd2da9dcd3a8","spl_product_data_elements":["Ionite APF Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION CITRIC ACID MONOHYDRATE FD&C RED NO. 40 MAGNESIUM ALUMINUM SILICATE PHOSPHORIC ACID POLYSORBATE 20 WATER SODIUM BENZOATE SACCHARIN SODIUM TITANIUM DIOXIDE .ALPHA.-TOCOPHEROL ACETATE, DL- XANTHAN GUM XYLITOL"],"storage_and_handling":["Store at 59 o - 86 o F (15 o - 30 o C) Protect from freezing Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products"],"version":"3","warnings_and_cautions":["Keep out of the 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. Do not use on patients with an allergy Fluoride. Ionite APF Gel contains artificial color, confirm that no kno.wn patient allergies exist. For professional use only."]}