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 23:46:39

Label at a glance#

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

Dosage and administration

Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or doctor. Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. 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 Ingredients

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 older

SPL UNCLASSIFIED SECTION

Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or doctor.

Children 6 to 12 years

SPL UNCLASSIFIED SECTION

Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 6 years

SPL UNCLASSIFIED SECTION

Do 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!

LUSTER
PREMIUM WHITE®

POWER WHITE PRO
SONIC DENTAL WHITENING SYSTEM

UP TO 6 SHADES WHITER†

DEEP SONIC POWER
WHITENING TECHNOLOGY

30,000
VIBRATIONS/MIN.

3 EASY
STEPS

ENAMEL SAFE
GENTLE & SULFATE-FREE

POWER SONIC TOOTHBRUSH • 2 AA BATTERIES • 2 BRUSH HEADS
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-160-13Luster Premium White Pro Sonic 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 SONIC DENTAL WHITENING SYSTEM (SODIUM MONOFLUOROPHOSPHATE) KIT [FRENCH TRANSIT, LTD.]3Legacy NDC20220113_ef2c8cc5-8aea-4ad1-8d5f-645b092e0157.zip
72805-160LUSTER PREMIUM WHITE PRO SONIC DENTAL WHITENING SYSTEM (SODIUM MONOFLUOROPHOSPHATE) KIT [FRENCH TRANSIT, LTD.]3Legacy NDC, 1 package rows20220113_ef2c8cc5-8aea-4ad1-8d5f-645b092e0157.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
72805-16072805-160-13
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
9cc79dda-334a-46f4-9a4d-43b09274cd09ef2c8cc5-8aea-4ad1-8d5f-645b092e01572022-01-12WarningsExact identifier
spl id: 9cc79dda-334a-46f4-9a4d-43b09274cd09
spl set id: ef2c8cc5-8aea-4ad1-8d5f-645b092e0157

Reported adverse events (FAERS/openFDA)#

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