EUROFRESH WHITENING- sodium fluoride paste, dentifrice

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Farmasi US LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Helps protect against cavities Helps whiten teeth
Authorization status:
OTC monograph final
Authorization number:
74690-008-01

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EUROFRESH WHITENING- sodium fluoride paste, dentifrice

Farmasi US LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply 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 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:

EUROFRESH WHITENING

sodium fluoride paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:746 9 0 -0 0 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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 Ingredients

Ingredient Name

Stre ng th

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

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 Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

12/0 1/20 20

Labeler -

Farmasi US LLC (113303351)

Revised: 12/2020

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