Label: MASTIC DENT OULO ACTION- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated December 26, 2012

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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, 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:15304-4681
    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)  
    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
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Mint Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15304-4681-175 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 LTD363215270manufacture(15304-4681) , label(15304-4681) , pack(15304-4681)
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