Label: EMMI-DENT WHITENING- 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 0.32% (0.19% 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

    Agua, hydrated silica, hydrogenated starch hydrolysate, propylene glycol, penta sodium triphosphate, tetra potassium pyrophosphate, sodium C14-16 olefin sulfonate, dicalcium phosphate dihydrate, disodium pyrophosphate, silica, cellulose gum, aroma, sodium saccharin, zinc lactate citric acid, sodium sulfate, sodium chloride, benzyl alcohol, CI 42051

  • Questions?

    1-833-682-8902

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

    emmi® DENT

    WHITENING

    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 WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63956-003
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium Fluoride320 mg  in 75 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Hydrogenated Starch Hydrolysate (UNII: 27F77DSJ5V)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Tripolyphosphate Anhydrous (UNII: 9SW4PFD2FZ)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Cellulose Gum (UNII: K679OBS311)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Zinc Lactate (UNII: 2GXR25858Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Sodium Sulfate (UNII: 0YPR65R21J)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    PATENT BLUE V (UNII: 8QE473DV1Z)  
    Product Characteristics
    ColorWHITE, BLUE (White and Blue stripes) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63956-003-031 in 1 CARTON07/30/2019
    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 DrugM02107/30/2019
    Labeler - EMAG AG (343617614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weckerle Cosmetics341251644MANUFACTURE(63956-003)
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