Luster Premium White

Manufacturer
French Transit, Ltd.
Effective date
2022-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:36

Label at a glance#

ProductLuster Premium White Pro Light Dental Whitening System
Active ingredientSodium Monofluorophosphate
Label structure10 sections

Dosage and administration

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.

Storage and handling

Store between 10-27°C (50-80°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.88% (w/w)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Helps protect against cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and olderBrush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or doctor.
Children 6 to 12 yearsInstruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 6 yearsDo not use unless directed by a dentist or physician.

Other information

STORAGE AND HANDLING SECTION

Store between 10-27°C (50-80°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-823-5272

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK!

LUSTER
PREMIUM WHITE®

BONUS
1OZ POWER
WHITE PRO™

PRO LIGHT
DENTAL WHITENING SYSTEM™

6 SHADES IN 30 MINUTES†

CLINICALLY PROVEN
PROFESSIONAL WHITENING TECHNOLOGY

REVERSE YEARS OF
STAINS IN 30 MIN.

3 EASY
STEPS

ENAMEL SAFE
GENTLE & SULFATE-FREE

DUAL-ENERGY WHITENING LIGHT • 4 AAA BATTERIES
ACCELERINSE 6 FL OZ (177 mL) • STAIN LIFTING SERUM .25 FL OZ (7 mL)
POWER WHITE PRO ANTICAVITY FLUORIDE TOOTHPASTE • MINT • NET WT. 1 OZ (28 g)

SATISFACTION GUARANTEED‡

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-170-13Luster Premium White Pro Light Dental Whitening System1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-150LUSTER PREMIUM WHITE PRO LIGHT DENTAL WHITENING SYSTEM (SODIUM MONOFLUOROPHOSPHATE) KIT [FRENCH TRANSIT, LTD.]3Legacy NDC20220113_235a44e1-8ef0-4310-9055-7c4eb9c319c2.zip
72805-170LUSTER PREMIUM WHITE PRO LIGHT DENTAL WHITENING SYSTEM (SODIUM MONOFLUOROPHOSPHATE) KIT [FRENCH TRANSIT, LTD.]3Legacy NDC, 1 package rows20220113_235a44e1-8ef0-4310-9055-7c4eb9c319c2.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72805-17072805-170-13
72805-15072805-150-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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
6ab82352-0605-4dfc-9100-05540256fff6235a44e1-8ef0-4310-9055-7c4eb9c319c22022-01-12WarningsExact identifier
spl id: 6ab82352-0605-4dfc-9100-05540256fff6
spl set id: 235a44e1-8ef0-4310-9055-7c4eb9c319c2

Reported adverse events (FAERS/openFDA)#

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