EMMI-DENT KIDS- 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 Kids

Drug Facts

Active Ingredient

Sodium Fluoride 0.11% (0.06% 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, sodium C-14-16 olefin sulfonate, celluose gum, aroma/fragrance, titanium dioxide, sodium methylparaben, sodium saccharin

Questions?

1-833-682-8902

Distributed by Ultra Oral Care Inc.,
Spring, Texas, 77386
www.emmident-ultrasound.com

PRINCIPAL DISPLAY PANEL - 75 mL Tube

emmi®-dent

Emmi-dent Kids

Ultrasound Toothpaste

for
Kids

Made in Germany

Made by Emag Germany

Principal Display Panel - 75 mL Tube
EMMI-DENT KIDS 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63956-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride110 mg  in 75 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Methylparaben Sodium (UNII: CR6K9C2NHK)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
ColorWHITE (white homogeneous mass) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63956-002-0275 mL in 1 TUBE; Type 0: Not a Combination Product07/15/2019
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(63956-002)

Revised: 1/2023
Document Id: 3684f8bc-d7f9-4c96-8c9b-e50a55cfdcd1
Set id: 4accb6bc-c9f9-4af1-a766-4872d94d08b1
Version: 3
Effective Time: 20230106
 
EMAG AG