FDA.reportPublic FDA data

LUSTER POWER WHITE

Manufacturer
DENTOVATIONS INC | Lornamead Inc.
Effective date
2019-02-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:58:37

Label at a glance#

ProductLUSTER POWER WHITE DEEP STAIN ERASER
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure12 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

PURPOSE: Anti-cavity toothpaste

INDICATIONS & USAGE SECTION

USE: Helps protect against cavities

WARNINGS SECTION

WARNINGS:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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.

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dentovations, Inc.

Boston, MA 02116

Made in New England, U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 57353-106Luster Power White 57353-106

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1546238sodium monofluorophosphate 0.88 % ToothpastePSN3
1546238sodium monofluorophosphate 0.0088 MG/MG ToothpasteSCD3
1546238sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )ToothpasteSY3
1546238sodium monofluorophosphate 0.88 % ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57353-106-532020-09-27C16284748780-1ab0e2407-28ae-f274-e053-dbdaa90a6471Luster Power White
57353-106-532020-09-25C16284748780-1ab0e2407-28ae-f274-e053-dbdaa90a6471Luster Power White
57353-106-532020-07-22C16284748780-1ab0e2407-28ae-f274-e053-dbdaa90a6471Luster Power White

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57353-106-13LUSTER POWER WHITEDEEP STAIN ERASER113 g in 1 TUBEGEL, DENTIFRICE1133
57353-106-53LUSTER POWER WHITEDEEP STAIN ERASER1 in 1 BOXGEL, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57353-106LUSTER POWER WHITE DEEP STAIN ERASER (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [DENTOVATIONS INC]3Legacy NDC, 2 package rows20190227_25220ab5-04c5-430e-89ba-a9c9ea3d2a3a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57353-10657353-106-13, 57353-106-53

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CALCIUM PYROPHOSPHATEX69NU20D19IACT
STARCH, CORNO8232NY3SJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CARBOMER 934Z135WT9208IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
82d17cc6-fe5e-3a12-e053-2991aa0a8b5825220ab5-04c5-430e-89ba-a9c9ea3d2a3a2019-02-26WarningsExact identifier
spl id: 82d17cc6-fe5e-3a12-e053-2991aa0a8b58
spl set id: 25220ab5-04c5-430e-89ba-a9c9ea3d2a3a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.