Label: LUSTER PREMIUM WHITE AM/PM- sodium fluoride and sodium monofluorophosphate kit
- NDC Code(s): 72805-120-13
- Packager: French Transit, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 12, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
-
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. - Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
-
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. - Other information
- Inactive Ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL - Kit Carton
NEW!
LUSTER
PREMIUM WHITE®AM | PM
TOOTHPASTE REINVENTED3X WHITER IN 3 DAYS†
FRESHER BREATH
INSTANTLY WHITER TEETH
FIGHT CAVITIES
REMOVE DEEP STAINS
WHITEN INSIDE & OUT
STRONGER ENAMEL
PROVEN EFFECTIVE
PROFESSIONAL WHITENING TECHNOLOGYENAMEL SAFE / ZERO TOOTH SENSITIVITY
ANTICAVITY FLUORIDE TOOTHPASTE • MINT
AM NET WT. 4 OZ (113 g) | PM NET WT. 4 OZ (113 g)SATISFACTION GUARANTEED‡
-
INGREDIENTS AND APPEARANCE
LUSTER PREMIUM WHITE AM/PM
sodium fluoride and sodium monofluorophosphate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72805-120 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72805-120-13 1 in 1 CARTON 04/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 113 g Part 2 1 TUBE 113 g Part 1 of 2 AM
sodium fluoride pasteProduct Information Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.24 g in 100 g Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Silicon Dioxide (UNII: ETJ7Z6XBU4) Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Lauroyl Sarcosinate (UNII: 632GS99618) FD&C Blue No. 1 (UNII: H3R47K3TBD) Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F) Carboxymethylcellulose Sodium, unspecified (UNII: K679OBS311) Sodium Benzoate (UNII: OJ245FE5EU) Acesulfame Potassium (UNII: 23OV73Q5G9) Titanium Dioxide (UNII: 15FIX9V2JP) Xanthan Gum (UNII: TTV12P4NEE) Sodium Pyrophosphate (UNII: O352864B8Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 113 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 04/01/2018 Part 2 of 2 PM
sodium monofluorophosphate pasteProduct Information Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.88 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Calcium Pyrophosphate (UNII: X69NU20D19) Starch, Corn (UNII: O8232NY3SJ) Propylene Glycol (UNII: 6DC9Q167V3) Polyethylene Glycol 600 (UNII: NL4J9F21N9) Hydrogen Peroxide (UNII: BBX060AN9V) Sodium Lauroyl Sarcosinate (UNII: 632GS99618) Carboxymethylcellulose Sodium, unspecified (UNII: K679OBS311) Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC) Saccharin Sodium (UNII: SB8ZUX40TY) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 113 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 04/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 04/01/2018 Labeler - French Transit, Ltd. (100044380)