Luster Premium White

Manufacturer
French Transit, Ltd.
Effective date
2022-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:46:37

Label at a glance#

ProductLuster Premium White AM/PM
Active ingredientSodium Fluoride, Sodium Monofluorophosphate
Label structure18 sections

Dosage and administration

Adults and children 6 years of age and older Brush teeth thoroughly, preferably after each meal, at least once daily in the morning, 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

AM TOOTHPASTE

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (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 once daily in the morning, 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

Sorbitol, Silica, Water, Propylene Glycol, Sodium Lauroyl Sarcosinate, Flavor, Disodium Phosphate, PVM/MA Copolymer, Cellulose Gum, Sodium Benzoate, Potassium Acesulfame, Xanthan Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, FD&C Blue No. 1

SPL UNCLASSIFIED SECTION

PM TOOTHPASTE

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 once daily at night, 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!

LUSTER
PREMIUM WHITE®

AM | PM
TOOTHPASTE REINVENTED

3X WHITER IN 3 DAYS†

FRESHER BREATH

INSTANTLY WHITER TEETH

FIGHT CAVITIES

REMOVE DEEP STAINS

WHITEN INSIDE & OUT

STRONGER ENAMEL

PROVEN EFFECTIVE
PROFESSIONAL WHITENING TECHNOLOGY

ENAMEL SAFE / ZERO TOOTH SENSITIVITY

ANTICAVITY FLUORIDE TOOTHPASTE • MINT
AM NET WT. 4 OZ (113 g) | PM NET WT. 4 OZ (113 g)

SATISFACTION GUARANTEED‡

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN4
1546238sodium monofluorophosphate 0.88 % ToothpastePSN4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD4
1546238sodium monofluorophosphate 0.0088 MG/MG ToothpasteSCD4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4
1546238sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )ToothpasteSY4
1546238sodium monofluorophosphate 0.88 % ToothpasteSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-120-13Luster Premium White AM/PM1 in 1 CARTONKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-120LUSTER PREMIUM WHITE AM/PM (SODIUM FLUORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [FRENCH TRANSIT, LTD.]4Legacy NDC, 1 package rows20220113_94542fbc-fab4-4709-9741-7dcfca253ba2.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72805-12072805-120-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
3e70f61f-fbdb-46ff-a507-ca0ef8ecf2d094542fbc-fab4-4709-9741-7dcfca253ba22022-01-12WarningsExact identifier
spl id: 3e70f61f-fbdb-46ff-a507-ca0ef8ecf2d0
spl set id: 94542fbc-fab4-4709-9741-7dcfca253ba2

Reported adverse events (FAERS/openFDA)#

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