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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 6, 2023

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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

    PROFESSIONAL

    100% ULTRASOUND
    CLEANS GENTLY WITHOUT BRUSHING

    emmi®-dent

    Ultrasound toothpaste

    fresh

    Made in 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)  
    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 FINALpart35507/15/2019
    Labeler - EMAG AG (343617614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Durodont GmbH341254136MANUFACTURE(63956-004)
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