EMMI-DENT WHITENING- sodium fluoride paste, dentifrice 
EMAG AG

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.

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Emmi®-dent Whitening

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

sorbitol, water, hydrated silica, sodium bicarbonate, propylene glycol, pentasodium triphosphate, C-14-16 olefin sulfonate, celluose gum, aroma/fragrance, titanium dioxide, sodium saccharin, zinc chloride

Questions?

1-833-682-8902

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

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

emmi®-dent

Ultrasound Toothpaste

Whitening

Made in Germany

Ideal für
100% Ultraschall®
Made by Emag Germany

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton
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
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Sodium Bicarbonate (UNII: 8MDF5V39QO)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Tripolyphosphate Anhydrous (UNII: 9SW4PFD2FZ)  
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Zinc Chloride (UNII: 86Q357L16B)  
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 FINALpart35507/30/2019
Labeler - EMAG AG (343617614)
Establishment
NameAddressID/FEIBusiness Operations
Durodont GmbH341254136MANUFACTURE(63956-003)

Revised: 1/2023
Document Id: 21527bb7-b2ba-4c58-998e-7a6a22120feb
Set id: dbc0cfe0-24ef-4ee2-b975-4044624a592f
Version: 3
Effective Time: 20230106
 
EMAG AG