EUROFRESH WHITENING- sodium fluoride paste, dentifrice 
Farmasi US LLC

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Eurofresh Whitening Toothpaste

DRUG FACTS

ACTIVE INGREDIENTS

Sodium Fluoride - 0.24%

PURPOSE

Anticavity

USE

Helps protect against cavities

Helps whiten teeth

WARNINGS

Do not use

if irritation occurs and persists.

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.

DIRECTION

INACTIVE INGREDIENTS

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?

info@farmasius.com 1786 236 7338

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

Package Labeling:

LabelLabel2

EUROFRESH WHITENING 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74690-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.08 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TEA TREE OIL (UNII: VIF565UC2G)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SALVADORA PERSICA ROOT (UNII: 526M7ZU616)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74690-008-011 in 1 BOX12/01/2020
1112 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02112/01/2020
Labeler - Farmasi US LLC (113303351)

Revised: 11/2023
Document Id: 0973365b-3496-8024-e063-6294a90a60c8
Set id: b56b2b55-e3a4-785a-e053-2a95a90a7abf
Version: 2
Effective Time: 20231105
 
Farmasi US LLC