ONETOOTH CLINIC TOOTH- silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste

ONETOOTH CLINIC TOOTH by

Drug Labeling and Warnings

ONETOOTH CLINIC TOOTH by is a Otc medication manufactured, distributed, or labeled by CONE MEDICAL Co., Ltd., Sungwon Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate

PURPOSE

For dental health

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Brushing the teeth with a suitable amount

WARNINGS

• Do not swallow and rinse mouth thoroughly after use
• If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.
• For children under 6 years of age, use small amounts of toothpaste. And
• use itunder the supervision of a guardian to avoid sucking or swallowing.
• Consult a physician or dentist immediately if a child under 6 years old
• hasswallowed large quantities.
• Keep out of the reach of children under 6 years of age.

INACTIVE INGREDIENT

D-Sorbitol Solution, Concentrated Glycerin, Carboxymethylcellulose Sodium, Hydroxyapatite, Medicinal Carbon, Chitosan, Titanium Oxide and Mica, Zeolite, Xylitol, Steviol Glycoside, Papain, Grapefruit Seed Extract, L-Menthol, Mentha Oil, Propolis Extract, Chamomile Extract, Rosemary Extract, Sage Extract, Aloe Extract, Glycyrrhiza Extract, Lavender Oil, Horsetail Extract, Sodium Cocoyl Glutamate, Lauroyl Amidopropyl Dimethyl Glycine Solution, Deionized Water

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONETOOTH CLINIC TOOTH 
silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73527-0002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	0.5 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	14 g  in 100 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73527-0002-1	20 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2021

Labeler - CONE MEDICAL Co., Ltd. (695811691)

Registrant - CONE MEDICAL Co., Ltd. (695811691)

Establishment
Name	Address	ID/FEI	Business Operations
HealingStory.,LTD.		688403124	manufacture(73527-0002)

Establishment
Name	Address	ID/FEI	Business Operations
CONE MEDICAL Co., Ltd.		695811691	label(73527-0002)