EMMI-DENT FRESH- sodium fluoride paste, dentifrice

Emmi-dent Fresh by

Drug Labeling and Warnings

Emmi-dent Fresh by is a Otc medication manufactured, distributed, or labeled by EMAG AG, Durodont GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EMMI-DENT FRESH 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63956-004
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	199 mg  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (white homogeneous mass)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63956-004-01	1 in 1 CARTON	07/15/2019
1		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	07/15/2019

Labeler - EMAG AG (343617614)

Establishment
Name	Address	ID/FEI	Business Operations
Durodont GmbH		341254136	MANUFACTURE(63956-004)