EMMI-DENT FRESH- 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 Fresh

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

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
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)

Revised: 1/2023
Document Id: 44d1ed60-1de5-49e0-bfe4-45208180a4e9
Set id: 1986a759-7dec-4287-884b-556cf314679e
Version: 3
Effective Time: 20230106
 
EMAG AG