FDA.reportPublic FDA data

SODIUM FLUORIDE

Manufacturer
Buzz Export Services Pty., Ltd.
Effective date
2021-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:20:46

Label at a glance#

ProductDELTA ONE 2019 TUMI COLLINS And TUMI COLLINS BOMBAS AMENITY With Crest 3D White Brilliance
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's brushing until good habits are established children under 2 yrs.: ask a dentist

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, PEG-20M or PEG-23M, xanthan gum, sucralose, mica, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

DELTA ONE 2019 - TUMI COLLINS & TUMI COLLINS BOMBAS - AMENITY KIT With Crest 3D White Brilliance (69491-200-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KItKIt

CREST 3D WHITE BRILLIANCE 24g (37000-873-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelPastePasteBrushBrush

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69491-200-002023-01-30C16284748780-1f386c649-a534-0266-e053-dadaa90a7c1aDELTA ONE 2019 - TUMI COLLINS & TUMI COLLINS BOMBAS - AMENITY KIT With Crest 3D White Brilliance

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-873DELTA ONE 2019 TUMI COLLINS AND TUMI COLLINS BOMBAS AMENITY WITH CREST 3D WHITE BRILLIANCE (SODIUM FLUORIDE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]3Current NDC, Legacy NDC20211228_cbf8e13e-a12d-408d-bc6f-39846a31b564.zip
69491-200DELTA ONE 2019 TUMI COLLINS AND TUMI COLLINS BOMBAS AMENITY WITH CREST 3D WHITE BRILLIANCE (SODIUM FLUORIDE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]3Legacy NDC20211228_cbf8e13e-a12d-408d-bc6f-39846a31b564.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
69491-20069491-200-00
37000-87337000-873-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
HEXASODIUM HEXAMETAPHOSPHATEN40N91DW96IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
METHYL SALICYLATELAV5U5022YIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARRAGEENAN5C69YCD2YJIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POLYETHYLENE OXIDE 90000016P9295IILIACT
XANTHAN GUMTTV12P4NEEIACT
SUCRALOSE96K6UQ3ZD4IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
ndc (product): 37000-873
0cfd238f-51ed-9183-e063-6394a90ad789cbf8e13e-a12d-408d-bc6f-39846a31b5642023-12-20WarningsExact identifier
spl set id: cbf8e13e-a12d-408d-bc6f-39846a31b564

Reported adverse events (FAERS/openFDA)#

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