Eurofresh Whitening

Manufacturer
Farmasi US LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:05

Label at a glance#

ProductEurofresh Whitening
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride - 0.24%

PURPOSE

OTC - PURPOSE SECTION

Anticavity

USE

INDICATIONS & USAGE SECTION

Helps protect against cavities

Helps whiten teeth

WARNINGS

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if irritation occurs and persists.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DIRECTION

DOSAGE & ADMINISTRATION SECTION

  • Supervise children as necessary until capable of using without supervision.
  • Do not swallow.
  • Rinse away toothpaste residue thoroughly after brushing.
  • Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.
  • Children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing).
  • Children under 2 years: ask a dentist or physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Sorbitol, Water/Aqua, Hydrated Silica, Lauryl Glucoside, Xanthan Gum, Flavour/Aroma, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tea Tree Oil/Melaleuca alternifolia Leaf Oil, Panax Ginseng Root Extract, aloe Juice Barbadensis Leaf juice, Salvadora Persica Bark/Root Extract.

Questions or Comments?

OTC - QUESTIONS SECTION

info@farmasius.com 1786 236 7338

Monday - Friday (9 a.m-6 p.m. EST)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74690-008-01Eurofresh Whitening1 in 1 BOXPASTE, DENTIFRICE12
74690-008-01Eurofresh Whitening112 g in 1 TUBEPASTE, DENTIFRICE1122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74690-008EUROFRESH WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [FARMASI US LLC]2Current NDC, Legacy NDC, 2 package rows20231106_b56b2b55-e3a4-785a-e053-2a95a90a7abf.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74690-00874690-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
ndc (package): 74690-008-01
ndc (product): 74690-008
ndc11 (package): 74690000801
spl id: 0973365b-3496-8024-e063-6294a90a60c8
spl set id: b56b2b55-e3a4-785a-e053-2a95a90a7abf

Reported adverse events (FAERS/openFDA)#

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