EMMI-DENT WHITENING- sodium fluoride paste, dentifrice

Emmi-dent Whitening by

Drug Labeling and Warnings

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

Drug Details [pdf]

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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

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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

INGREDIENTS AND APPEARANCE

EMMI-DENT WHITENING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63956-003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	Sodium Fluoride	320 mg  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
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 Form (UNII: K679OBS311)
Titanium Dioxide (UNII: 15FIX9V2JP)
Saccharin Sodium (UNII: SB8ZUX40TY)
Zinc Chloride (UNII: 86Q357L16B)

Product Characteristics
Color	WHITE, BLUE (White and Blue stripes)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63956-003-03	1 in 1 CARTON	07/30/2019
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	07/30/2019

Labeler - EMAG AG (343617614)

Establishment
Name	Address	ID/FEI	Business Operations
Durodont GmbH		341254136	MANUFACTURE(63956-003)