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Mastic Dent Oulo Action (Chia Gi LTD)

Available Formats

Dosage Form Package Information Links
PASTE, DENTIFRICE 75 mL in 1 TUBE (15304-4681-1) Label Information

Complete Mastic Dent Oulo Action Information

  • 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, Peg-8, Fragrance, Sodium Lauryl Sarcosinate, 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


  • Image of Label

    toothpaste box


  • INGREDIENTS AND APPEARANCE
    MASTIC DENT OULO ACTION 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:15304-4681
    Route of Administration ORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ENOXOLONE (UNII: P540XA09DR)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    MENTHOL (UNII: L7T10EIP3A)  
    PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    .ALPHA.-BISABOLOL, ()- (UNII: 36HQN158VC)  
    CHAMOMILE (UNII: FGL3685T2X)  
    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:15304-4681-1 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 manufacture(15304-4681) , label(15304-4681) , pack(15304-4681)