Label: MASTIC DENT WHITENING- sodium fluoride paste, dentifrice 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Drug Facts:

    Active Ingredients:

    • Sodium Fluoride 0.22% (0.12% w/v fluoride ion) - Anticavity

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  • Warnings

    Warnings:

    • When using this product, if irritation occurs discontinue use.
    • Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a poison control Center right away.

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  • Dosage

    Use a pea-sized amount

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  • Keep out of reach.

    Keep out of reach of children under 6 years of age.

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  • Directions

    Directions:

    • Adults and children 2 years and older.
    • Brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
    • Instruct in good brushing and rinsing habits (to minimize swallowing).
    • ​Children under 2 years​ do not use unless directed by a dentist or a physician.
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  • Inactive Ingredients

    Inactive Ingredients:

    Water, Sorbitol, Hydrated Silica, Glycerine, Sodium Lauroyl Sarcosinate, Peg-8, Calcium Pyrophosphate, Fragrance, Xanthan Gum, Titanium Dioxide, Chamomilla Recutita, Camelia Sinensis, Menthol Crystals, Sodium Saccharin, Allantoin, Pistacia Lentiscus (Mastic) Gum, Bisabolol, Glycyrrhetinic Acid, Sodium Hydroxide

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  • Information of owner

    Product Of Chios

    CHIA GI LTD

    144 AG. MINA, HIOS, 82100

    GREECE
    Tel.: 30-22710-33101, FAX: 30-22710-32229
    www.masticspa.com
    Made In Greece
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  • PURPOSE SECTION

    Aids in the prevention of dental cavities-plaque

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  • Image of Label
  • INGREDIENTS AND APPEARANCE
    MASTIC DENT WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:15304-4182
    Route of Administration ORAL, DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ENOXOLONE  
    POLYETHYLENE GLYCOL 400  
    SODIUM HYDROXIDE  
    ALLANTOIN  
    SORBITOL  
    GLYCERIN  
    CALCIUM PYROPHOSPHATE  
    SACCHARIN SODIUM  
    TITANIUM DIOXIDE  
    XANTHAN GUM  
    CAMELLIA SINENSIS SEED OIL  
    SODIUM LAUROYL SARCOSINATE  
    MENTHOL  
    PISTACIA LENTISCUS RESIN  
    HYDRATED SILICA  
    .ALPHA.-BISABOLOL, ()-  
    CHAMOMILE  
    CAMELLIA SINENSIS SEED OIL  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor MINT (Mint Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15304-4182-1 75 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 11/22/2005
    Labeler - Chia Gi LTD (363215270)
    Registrant - Chia Gi LTD (363215270)
    Establishment
    Name Address ID/FEI Business Operations
    Chia Gi LTD 363215270 label(15304-4182), manufacture(15304-4182), pack(15304-4182)
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