{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Luster Premium White AM/PM Sodium Fluoride and Sodium Monofluorophosphate AM Sodium Fluoride Sodium Fluoride Fluoride Ion Sorbitol Silicon Dioxide Water Propylene Glycol Sodium Lauroyl Sarcosinate FD&C Blue No. 1 Sodium Phosphate, Dibasic, Anhydrous Carboxymethylcellulose Sodium, unspecified Sodium Benzoate Acesulfame Potassium Titanium Dioxide Xanthan Gum Sodium Pyrophosphate PM Sodium Monofluorophosphate Sodium Monofluorophosphate Fluoride Ion Water Calcium Pyrophosphate Starch, Corn Propylene Glycol Polyethylene Glycol 600 Hydrogen Peroxide Sodium Lauroyl Sarcosinate Carboxymethylcellulose Sodium, unspecified Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) Saccharin Sodium Butylated Hydroxytoluene" ], "spl_unclassified_section": [ "AM TOOTHPASTE Drug Facts", "PM TOOTHPASTE Drug Facts" ], "active_ingredient": [ "Active ingredient Sodium Fluoride 0.24% (w/w)", "Active ingredient Sodium Monofluorophosphate 0.88% (w/w)" ], "purpose": [ "Purpose Anticavity", "Purpose Anticavity" ], "indications_and_usage": [ "Use Helps protect against cavities.", "Use Helps protect against cavities." ], "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.", "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." ], "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.", "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." ], "dosage_and_administration": [ "Directions Adults and children 6 years of age and older Brush teeth thoroughly, preferably after each meal, at least once daily in the morning, or as directed by a dentist or doctor. Children 6 to 12 years Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years Do not use unless directed by a dentist or physician.", "Directions Adults and children 6 years of age and older Brush teeth thoroughly, preferably after each meal, at least once daily at night, or as directed by a dentist or doctor. Children 6 to 12 years Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years Do not use unless directed by a dentist or physician." ], "dosage_and_administration_table": [ "
Adults and children 6 years of age and olderBrush teeth thoroughly, preferably after each meal, at least once daily in the morning, or as directed by a dentist or doctor.
Children 6 to 12 yearsInstruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 6 yearsDo not use unless directed by a dentist or physician.
", "
Adults and children 6 years of age and olderBrush teeth thoroughly, preferably after each meal, at least once daily at night, or as directed by a dentist or doctor.
Children 6 to 12 yearsInstruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 6 yearsDo not use unless directed by a dentist or physician.
" ], "storage_and_handling": [ "Other information Store between 10-27°C (50-80°F)", "Other information Store between 10-27°C (50-80°F)" ], "inactive_ingredient": [ "Inactive ingredients Sorbitol, Silica, Water, Propylene Glycol, Sodium Lauroyl Sarcosinate, Flavor, Disodium Phosphate, PVM/MA Copolymer, Cellulose Gum, Sodium Benzoate, Potassium Acesulfame, Xanthan Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, FD&C Blue No. 1", "Inactive Ingredients Vegetable Glycerin, Calcium Pyrophosphate, Zea Mays (Corn) Starch, Propylene Glycol, PEG-12, Water, Hydrogen Peroxide, Sodium Lauroyl Sarcosinate, Flavor, Cellulose Gum, Carbomer, Sodium Saccharin, Butylated Hydroxytoluene" ], "questions": [ "Questions? 1-800-823-5272" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Kit Carton NEW! LUSTER PREMIUM WHITE ® AM | PM TOOTHPASTE REINVENTED 3X WHITER IN 3 DAYS † FRESHER BREATH INSTANTLY WHITER TEETH FIGHT CAVITIES REMOVE DEEP STAINS WHITEN INSIDE & OUT STRONGER ENAMEL PROVEN EFFECTIVE PROFESSIONAL WHITENING TECHNOLOGY ENAMEL SAFE / ZERO TOOTH SENSITIVITY ANTICAVITY FLUORIDE TOOTHPASTE • MINT AM NET WT. 4 OZ (113 g) | PM NET WT. 4 OZ (113 g) SATISFACTION GUARANTEED ‡ PRINCIPAL DISPLAY PANEL - Kit Carton" ], "set_id": "94542fbc-fab4-4709-9741-7dcfca253ba2", "id": "3e70f61f-fbdb-46ff-a507-ca0ef8ecf2d0", "effective_time": "20220112", "version": "4", "openfda": {} } ] }