Label: EMMI-DENT FRESH- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 3, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium Fluoride 0.199% (0.11% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warning

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

    If more than used for dental cleaning is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    *
    adults and children 2 yrs. & older: clean teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    *
    do not swallow
    *
    to minimize swallowing use a pea-sized amount in children unter 6
    *
    supervise children's dental cleaning until good habits are established
    *
    children under 2 yrs.: ask a dentist
  • Inactive ingredients

    water, sorbitol, hydrated silica, propylene glycol, tetrapotassium pyrophosphate, xanthan gum, sodium C-14-16 olefin sulfonate, aroma, mentha arvenis leaf oil, titanium dioxide, sodium methyl paraben, sodium saccharin, allantoin, chamomilla recutita (matricaria) flower extract, salvia triloba leaf extract

  • Questions?

    1-833-682-8902

  • SPL UNCLASSIFIED SECTION

    Distributed by Ultra Oral Care Inc. , Spring, Texas, 77386

    www.emmident-ultrasound.com

  • PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton

    emmi® DENT

    FRESH
    PROFESSIONAL

    emmi® DENT

    100% ULTRASOUND

    Ultrasound Toothpaste

    Made in Germany

    Ideal

    100% Ultraschall®

    Made by EMAG Germany

    PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    EMMI-DENT FRESH 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63956-004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION199 mg  in 75 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Mentha Arvensis Leaf oil (UNII: 1AEY1M553N)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Allantoin (UNII: 344S277G0Z)  
    CHAMOMILE (UNII: FGL3685T2X)  
    THREE-LOBE SAGE (UNII: 3V97D33N0K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorWHITE (white homogeneous mass) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63956-004-011 in 1 CARTON07/15/2019
    175 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02107/15/2019
    Labeler - EMAG AG (343617614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weckerle Cosmetics341251644MANUFACTURE(63956-004)
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