LUSTER POWER WHITE DEEP STAIN ERASER- sodium monofluorophosphate gel, dentifrice 
DENTOVATIONS INC

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.

----------

Luster Power White

Drug Facts

ACTIVE INGREDIENT: Sodium Monofluorophosphate 0.88% (w/w)

PURPOSE: Anti-cavity toothpaste

USE: Helps protect against cavities

WARNINGS:

Keep out of reach of children under 12 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away. Avoid contact of the product with the eyes. If irritation (such as redness, swelling or soreness) of the gums or the mouth occurs, discontinue use and consult a dentist.

DIRECTIONS: Adults and children 12 years of age and older. For the best results brush teeth thoroughly, preferably after each meal or least twice a day, or as directed by a dentist. Do not swallow. Product is not recommended for use by children under 12 years of age.

OTHER INFORMATION: Store between 50°F (10°C) and 80°F (27°C)

INACTIVE INGREDIENTS: Calcium Pyrophosphate, Vegetable Glycerin, Zea Mays (Corn) Starch, Propylene Glycol, PEG-12, Water, Sodium Lauroyl Sarcosinate, Hydrogen Peroxide, Carbomer, Cellulose Gum, Flavor, Sodium Saccharin, Piroctone Olamine

QUESTIONS OR COMMENTS?

Call 1-800-823-5727 (M-F 9 A.M. - 5 P.M. EST)

visit LusterPowerWhite.com, email: info@lusterpremiumwhite.com or follow: @LusterPremWhite

Dentovations, Inc.

Boston, MA 02116

Made in New England, U.S.A.

LUSTER PREMIUM WHITE

POWER WHITE

DEEP STAIN ERASER

FLUORIDE TOOTHPASTE

REMOVES UP TO 95% OF SURFACE STAINS IN 5 DAYS

ENAMEL SAFE

PEROXIDE WHITENING

EXCITE-MINT FLAVOR

NET WT. 4 OZ (113 G)

Luster Power White 57353-106

LUSTER POWER WHITE  DEEP STAIN ERASER
sodium monofluorophosphate gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57353-106
Route of AdministrationORAL
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
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
CARBOMER 934 (UNII: Z135WT9208)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57353-106-531 in 1 BOX12/01/2012
1NDC:57353-106-13113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/2012
Labeler - DENTOVATIONS INC (128248676)
Registrant - Lornamead Inc. (078584069)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(57353-106)

Revised: 2/2019
Document Id: 82d17cc6-fe5e-3a12-e053-2991aa0a8b58
Set id: 25220ab5-04c5-430e-89ba-a9c9ea3d2a3a
Version: 3
Effective Time: 20190226
 
DENTOVATIONS INC