MASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]

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MASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]
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NDC 15304-4182-1
Set ID 9e98b782-111a-4cf0-98b4-774063a12217
Category HUMAN OTC DRUG LABEL
Packager Chia Gi LTD
Generic Name
Product Class
Product Number
Application Number PART355
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  • Active Ingredients

    Drug Facts:

    Active Ingredients:

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

  • 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.

  • Dosage

    Use a pea-sized amount

  • Keep out of reach.

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

  • 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.
  • 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

  • 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
  • PURPOSE SECTION

    Aids in the prevention of dental cavities-plaque

  • Image of Label

    toothpaste box

  • INGREDIENTS AND APPEARANCE
    MASTIC DENT WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15304-4182
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ENOXOLONE (UNII: P540XA09DR)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    MENTHOL (UNII: L7T10EIP3A)  
    PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    .ALPHA.-BISABOLOL, ()- (UNII: 36HQN158VC)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Mint Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15304-4182-175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/22/2005
    Labeler - Chia Gi LTD (363215270)
    Registrant - Chia Gi LTD (363215270)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chia Gi LTD363215270label(15304-4182) , manufacture(15304-4182) , pack(15304-4182)
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