L'ECLAT ROSE TOOTHPASTE- silicon dioxide, xylitol, tocopherol acetate paste, dentifrice

L'ECLAT Rose Toothpaste by

Drug Labeling and Warnings

L'ECLAT Rose Toothpaste by is a Otc medication manufactured, distributed, or labeled by Toaon Co., Ltd., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Silicon dioxide 12.0%, Xylitol 0.5%, Tocopherol Acetate 0.1%

INACTIVE INGREDIENT

Inactive ingredients:
Sorbitol, Purified Water, Glycerin, Sodium Cocoyl Glutamate, Sodium Cellulose Glycolate, Aroma (Rose Fruits), Menthol, Sodium Benzoate, Stevioside, Hydroxyapatite, Beet Red, Aloe Vera Leaf Extract, Sodium Hydrogen Carbonate, Eucalyptus Extract, Green Tea Extract, Sage Extract, Chamomile Extract, Rosemary Extract, Certified Organic Ingredients

PURPOSE

Purpose: Anti-plaque, Anti-cavity, Anti-gingivitis

WARNINGS

Warnings:
Keep out of the reach of children under 2 years of age. If you accidentally swallow more than used for brushing, seek professional assistance immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 2 years of age.

Uses

Uses:
Keep your teeth white and strong.
Keep your mouth clean.
Refresh the inside of the mouth.
To prevent tooth decay and remove bad breath.
Increase esthetic effect.
Removal of plaque (anti-plaque).
Prevention of gingivitis.
Prevention of Periodontal disease gum disease.

Directions

Directions:

For best results, brush after every meal and whenever you want your breath to be fresh.
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician).
Children under 2 years: Ask a dentist or physician

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

L'ECLAT ROSE TOOTHPASTE 
silicon dioxide, xylitol, tocopherol acetate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73175-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Silicon dioxide (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	Silicon dioxide	12.0 g  in 100 g
Xylitol (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E)	Xylitol	0.5 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73175-010-02	1 in 1 CARTON	06/01/2019
1	NDC: 73175-010-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2019

Labeler - Toaon Co., Ltd. (694977241)

Registrant - Toaon Co., Ltd. (694977241)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(73175-010)