Label: EUROFRESH WHITENING- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • 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:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    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)
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