EUROFRESH WHITENING- sodium fluoride paste, dentifrice

Eurofresh Whitening by

Drug Labeling and Warnings

Eurofresh Whitening by is a Otc medication manufactured, distributed, or labeled by Farmasi US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

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:

INGREDIENTS AND APPEARANCE

EUROFRESH WHITENING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74690-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.08 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74690-008-01	1 in 1 BOX	12/01/2020
1		112 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	12/01/2020

Labeler - Farmasi US LLC (113303351)