{"active_ingredient":["Active Ingredients Sodium Fluoride 0.24% 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":"5b14bdd2-2852-1c00-e063-6294a90ac4cc","inactive_ingredient":["Inactive Ingredients Glycerin, Aqua (Water), Silica, Sorbitol, Xylitol, Methyl Salicylate, Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140), Flavor (Aroma), Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum"],"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 Cool Mint"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Ultradent Products, Inc."],"package_ndc":["51206-314-01","51206-314-03","51206-314-02","51206-314-04","51206-314-05"],"product_ndc":["51206-314"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["416783"],"spl_id":["5b14bdd2-2852-1c00-e063-6294a90ac4cc"],"spl_set_id":["44e7d0ed-3c37-5889-e063-6294a90afcca"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 4.7 oz Tube Carton Opalescence Whitening Toothpaste Original Cool Mint Fluoride Toothpaste NET WT. 4.7 oz Opalescence Whitening Toothpaste Original Cool Mint_4.7 oz Tube Carton"],"purpose":["Purpose Anticavity"],"questions":["Questions or Comments Call toll-free 1.800.552.5512"],"set_id":"44e7d0ed-3c37-5889-e063-6294a90afcca","spl_product_data_elements":["Opalescence Whitening Cool Mint Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM LAURYL SULFATE FD&C YELLOW NO. 5 SODIUM HYDROXIDE AQUA SORBITOL SILICON DIOXIDE XYLITOL SUCRALOSE XANTHAN GUM METHYL SALICYLATE GLYCERIN SODIUM BENZOATE POLOXAMER 407 CARBOMER FD&C BLUE NO. 1"],"spl_unclassified_section":["Drug Facts"],"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":"4","warnings":["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"]}