Label: EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated April 22, 2014

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  • emmi dent Sodium Fluoride Anticavity Toothpaste Mild


  • Active Ingredient

    Sodium fluoride 0.243% (0.16 w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • Warnings

    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.

  • Directions

    • Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • Instruct children under 6 years of age in good brushing and rinsing habits  (to minimize swallowing).
    • Supervise children as necessary until capable of using without supervision.
    • Children under 2 years: Consult a dentist or doctor.
  • Inactive Ingredients

    water, hydrated silica, sorbitol, propylene glycol, tetrapotassium pyrophosphate, xanthan, gum, sodium C14-16 olefin sulfonate, flavor, titanium dioxide, sodium methylparaben, sodium saccharin, allantoin, limonene, chamomile (chamomilla recutita) flower extract, three-lobe sage (salvia triloba) leaf extract, citral

  • Representative Labeling

    OuterLabel
    InnerLabel
  • INGREDIENTS AND APPEARANCE
    EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63956-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LIMONEN-10-OL, (+)- (UNII: 1Q8KVB0R3J)  
    CHAMOMILE (UNII: FGL3685T2X)  
    THREE-LOBE SAGE (UNII: 3V97D33N0K)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63956-001-901 in 1 PACKAGE
    190.6 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/22/2014
    Labeler - EMAG AG (343617614)
    Registrant - EMAG AG (343617614)
    Establishment
    NameAddressID/FEIBusiness Operations
    EMAG AG343617614manufacture(63956-001)
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