{"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":"5b14e96f-d015-5738-e063-6294a90ac014","inactive_ingredient":["Inactive Ingredients Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Methyl Salicylate (flavor), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Cool Mint Flavor, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Wintermint Flavor, 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":["Opal by Opalescence Original"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Ultradent Products, Inc."],"package_ndc":["51206-312-02","51206-312-01"],"product_ndc":["51206-312"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["1044547"],"spl_id":["5b14e96f-d015-5738-e063-6294a90ac014"],"spl_set_id":["5c3bf8fc-2e8f-4a58-bcbf-e47540072a49"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton opal™ by Opalescence ® Whitening Toothpaste ORIGINAL COOL MINT FLUORIDE TOOTHPASTE NET WT. 4.7 OZ Principal Display Panel - 4.7 OZ Tube Carton"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments Call toll-free 1.800.496.8330"],"set_id":"5c3bf8fc-2e8f-4a58-bcbf-e47540072a49","spl_product_data_elements":["Opal by Opalescence Original Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION GLYCERIN WATER SILICON DIOXIDE SORBITOL XYLITOL METHYL SALICYLATE POLOXAMER 407 SODIUM LAURYL SULFATE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 FD&C YELLOW NO. 5 SODIUM BENZOATE SODIUM HYDROXIDE SUCRALOSE XANTHAN GUM"],"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":"6","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."]}