{"active_ingredient":["Active Ingredients Sodium Fluoride 0.25% w/w"],"dosage_and_administration":["Directions Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor."],"effective_time":"20260909","id":"5b14d90f-23ec-372b-e063-6294a90a2066","inactive_ingredient":["Inactive Ingredients Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Flavor (aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)"],"indications_and_usage":["Uses Aids in the prevention of dental decay."],"keep_out_of_reach_of_children":["Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M021"],"brand_name":["Opalescence Whitening"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Ultradent Products, Inc"],"package_ndc":["51206-302-07","51206-302-10","51206-302-06","51206-302-08","51206-302-09","51206-302-11"],"product_ndc":["51206-302"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["1044547"],"spl_id":["5b14d90f-23ec-372b-e063-6294a90a2066"],"spl_set_id":["d07f842e-b6f1-4ae1-b576-f542ecd02dd4"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 ml Tube Box Opalescence™ whitening toothpaste NET WT. 4.7 oz • 133 g • 100 ml FLUORIDE TOOTHPASTE Original Cool Mint Principal Display Panel - 100 ml Tube Box"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments Call toll-free 1.800.552.5512"],"set_id":"d07f842e-b6f1-4ae1-b576-f542ecd02dd4","spl_product_data_elements":["Opalescence Whitening Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION GLYCERIN SACCHARIN SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5 XANTHAN GUM SODIUM LAURYL SULFATE WATER SORBITOL SODIUM BENZOATE XYLITOL SILICON DIOXIDE METHYL SALICYLATE"],"spl_unclassified_section":["Drug Facts","Manufactured by: Ultradent Products, Inc., South Jordan, UT 84095, USA"],"storage_and_handling":["Other Information Do not use if tamper-evident seal is broken Store at room temperature Contains FD&C Yellow No. 5 (tartrazine) as a color additive"],"version":"10","warnings":["Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."]}