ONETOOTHCLINIC TOOTH- silicon dioxide, tocopherol acetate, sodium pyrophosphate paste

ONETOOTHCLINIC TOOTH by

Drug Labeling and Warnings

ONETOOTHCLINIC 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

sorbitol, etc

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONETOOTHCLINIC TOOTH 
silicon dioxide, tocopherol acetate, sodium pyrophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73527-0001
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
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73527-0001-1	100 g in 1 TUBE; Type 0: Not a Combination Product	11/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/14/2019

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Sungwon Pharmaceutical Co., Ltd.		689787898	manufacture(73527-0001)

Establishment
Name	Address	ID/FEI	Business Operations
CONE MEDICAL Co., Ltd.		695811691	label(73527-0001)