LUSTER PREMIUM WHITE

Manufacturer
French Transit, Ltd.
Effective date
2020-10-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:32:24

Label at a glance#

ProductLUSTER PREMIUM WHITE
Active ingredientSODIUM FLUORIDE
Label structure9 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 adentist 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 dentist or physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.24% (0.15% W/V FLUORIDE ION)

PURPOSE

OTC - PURPOSE SECTION

ANTI-CAVITY

USE

INDICATIONS & USAGE SECTION

HELPS PROTECT AGAINST CAVITIES.

WARNINGS

WARNINGS SECTION

If you accidentally swallow more than used for brushing, get medical help,

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older—Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by adentist 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 dentist or physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Glycerin, Sorbitol, Hydrated Silica, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mica, Titanium Dioxide, Charcoal Powder, Mentha Arvensis (Cornmint) Leaf Oil, Menthol, Vanilla Planifolia Fruit Extract

QUESTIONS

OTC - QUESTIONS SECTION

1-800-823-5272 | French Transit, Ltd., Louisville, CO 80027 USA
*Visit LusterPremiumWhite.com for more information.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_Luster Premium White_4oz01b UC_Luster Premium White_4oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN5
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD5
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY5
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY5
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72805-201-142022-01-28C16284748780-1d6a99b39-febf-a426-e053-dadaa90af4c2LUSTER PREMIUM WHITE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-201-14LUSTER PREMIUM WHITE113 g in 1 TUBEGEL, DENTIFRICE1135
72805-201-14LUSTER PREMIUM WHITE1 in 1 BOXGEL, DENTIFRICE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-201LUSTER PREMIUM WHITE (SODIUM FLUORIDE) GEL, DENTIFRICE [FRENCH TRANSIT, LTD.]5Legacy NDC, 2 package rows20201025_e29f8a27-3a2f-4a48-9619-5154cbd9d406.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72805-20172805-201-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
59586abd-512c-42c6-a74d-fda87ce8fd33e29f8a27-3a2f-4a48-9619-5154cbd9d4062020-10-24WarningsExact identifier
spl id: 59586abd-512c-42c6-a74d-fda87ce8fd33
spl set id: e29f8a27-3a2f-4a48-9619-5154cbd9d406

Reported adverse events (FAERS/openFDA)#

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