Label: LUSTER PREMIUM WHITE POWER WHITE PRO- sodium monofluorophosphate paste
- NDC Code(s): 72805-140-13, 72805-150-28
- 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 Ingredients
- Purpose
- Use
- Warnings
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Directions
Adults and children 6 years of age and older
Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or doctor.
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 113 g Tube Box
- PRINCIPAL DISPLAY PANEL - 28 g Tube Label
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INGREDIENTS AND APPEARANCE
LUSTER PREMIUM WHITE POWER WHITE PRO
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72805-140 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 NDC:72805-140-13 1 in 1 BOX 04/01/2018 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/01/2018 LUSTER PREMIUM WHITE POWER WHITE PRO
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72805-150 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 NDC:72805-150-28 28 g in 1 TUBE; Type 0: Not a Combination Product 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)