TOOTH NOTE MOISTURIZING THERAPY TOOTH GRAPEFRUIT- dental type silica, tocopheryl acetate paste, dentifrice

TOOTH NOTE Moisturizing Therapy Tooth GRAPEFRUIT by

Drug Labeling and Warnings

TOOTH NOTE Moisturizing Therapy Tooth GRAPEFRUIT by is a Otc medication manufactured, distributed, or labeled by GI BILLIONS Co.,Ltd. , Biostech Co., Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dental Type Silica, Tocopheryl Acetate

INACTIVE INGREDIENT

L-menthol, Other Salts, Rosmarinus Oficinalis (Rosemary) Extract, Centella asiatica extract, Potassium Acesulfame, Aloe barbadensis leaf extract, Glycerin, Sodium Chloride, Xylitol, Purified Water, Calendula officinalis extract, Cellulose gum, Chamomilla recutita (Matricaria) leaf extract, Sodium cocoyl glutamate, Sodium bicarbonate, Flavor, Charcoal Powder, Hydoxyapatite, Sodium hyaluronate

PURPOSE

Helps protect against cavities

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Brush the teeth with an appropriate amount of toothpaste.

WARNINGS

1) Be careful not to swallow, and rinse mouth thoroughly after use
2) If the use of toothpaste causes abnormalities such as gums or mouth injuries, discontinue use and consult a doctor or dentist
3) If you are a child under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the supervision of a guardian to avoid sucking or swallowing
4 If a child under 6 years of age swallowed large quantities, consult a physician or dentist immediately
5) Keep out of the reach of children under 6 years

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOOTH NOTE MOISTURIZING THERAPY TOOTH GRAPEFRUIT 
dental type silica, tocopheryl acetate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81581-0002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	20 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
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
LEVOMENTHOL (UNII: BZ1R15MTK7)
CENTELLA ASIATICA (UNII: 7M867G6T1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81581-0002-1	150 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2021

Labeler - GI BILLIONS Co.,Ltd. (695631555)

Registrant - GI BILLIONS Co.,Ltd. (695631555)

Establishment
Name	Address	ID/FEI	Business Operations
Biostech Co., Ltd.		687294330	manufacture(81581-0002)

Establishment
Name	Address	ID/FEI	Business Operations
GI BILLIONS Co.,Ltd.		695631555	label(81581-0002)