LUSTER PREMIUM WHITE  POWER WHITE PRO- sodium monofluorophosphate paste 
French Transit, Ltd.

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.

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Luster Premium White®
Power White Pro™

Drug Facts

Active Ingredients

Sodium Monofluorophosphate 0.88% (w/w)

Purpose

Anticavity

Use

Helps protect against cavities.

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.

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.

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

Store between 10-27 degrees Celsius (50-80 degrees Fahrenheit)

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?

1-800-823-5272

PRINCIPAL DISPLAY PANEL - 113 g Tube Box

NEW!

LUSTER
PREMIUM WHITE®

POWER
WHITE PRO
DEEP STAIN ERASER®

ANTICAVITY FLUORIDE
TOOTHPASTE

PROVEN EFFECTIVE
TO REMOVE UP TO 95%
OF SURFACE STAINS
IN 5 DAYS†

DAILY CARE + WHITENING

ENAMEL SAFE
GENTLE & SULFATE-FREE

MINT
NET WT. 4 OZ (113 g)

SATISFACTION GUARANTEED‡

PRINCIPAL DISPLAY PANEL - 113 g Tube Box

PRINCIPAL DISPLAY PANEL - 28 g Tube Label

LUSTER
PREMIUM WHITE®

POWER
WHITE PRO™
DEEP STAIN ERASER®

ANTICAVITY FLUORIDE
TOOTHPASTE

PROVEN EFFECTIVE
TO REMOVE UP TO 95% OF
SURFACE STAINS IN 5 DAYS†

DAILY CARE + WHITENING

ENAMEL SAFE
ZERO SENSITIVITY

MINT
NET WT. 1 OZ (28 g)

SATISFACTION GUARANTEED

PRINCIPAL DISPLAY PANEL - 28 g Tube Label
LUSTER PREMIUM WHITE   POWER WHITE PRO
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-140
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.88 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 FORM (UNII: K679OBS311)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-140-131 in 1 BOX04/01/2018
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/2018
LUSTER PREMIUM WHITE   POWER WHITE PRO
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-150
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.88 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 FORM (UNII: K679OBS311)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-150-2828 g in 1 TUBE; Type 0: Not a Combination Product04/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/2018
Labeler - French Transit, Ltd. (100044380)

Revised: 12/2020
Document Id: b799406a-6bf2-46e8-90e8-b9ee4c62db5d
Set id: 6ecbbe6e-17d5-4674-9347-91da8572956c
Version: 2
Effective Time: 20201215
 
French Transit, Ltd.