EUROFRESH WHITENING- sodium fluoride pas te, dentifrice Farmas i US LLCDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 useif irritation occurs and persists.

Keep out of reach of childrenunder 6 years of age. If more than used for brushing is accidentally swallowed, get medical help orcontact a Poison Control Center right away.

DIRECTIONSupervise 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, oruse 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/Melaleucaalternifolia Leaf Oil, Panax Ginseng Root Extract, aloe Juice Barbadensis Leaf juice, Salvadora PersicaBark/Root Extract.

Questions or Comments?

info@farmasius.com 1786 236 7338Monday - Friday (9 a.m-6 p.m. EST)

Package Labeling:

EUROFRESH WHITENING sodium fluoride paste, dentifrice

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:746 9 0 -0 0 8

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) FLUORIDE ION 1.0 8 mg in 1 g

Inactive IngredientsIngredient Name Strength

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

SO RBITO L (UNII: 50 6 T6 0 A25R)

WATER (UNII: 0 59 QF0 KO0 R)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

LAURYL GLUCO SIDE (UNII: 76 LN7P7UCU)

XANTHAN GUM (UNII: TTV12P4NEE)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

TEA TREE O IL (UNII: VIF56 5UC2G)

ASIAN GINSENG (UNII: CUQ3A77YXI)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

SALVADO RA PERSICA RO O T (UNII: 526 M7ZU6 16 )

Farmasi US LLC

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:746 9 0 -0 0 8 -0 1 1 in 1 BOX 12/0 1/20 20

1 112 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part355 12/0 1/20 20

Labeler - Farmas i US LLC (113303351)

Revised: 12/2020