ONETOOTHCLINIC TOOTH- silicon dioxide, tocopherol acetate, sodium pyrophosphate paste 
CONE MEDICAL Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate

For dental health

For dental care

Keep out of reach of children

Brushing the teeth with a suitable amount

sorbitol, etc

For dental use only

label

ONETOOTHCLINIC TOOTH 
silicon dioxide, tocopherol acetate, sodium pyrophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73527-0001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE0.5 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE14 g  in 100 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73527-0001-1100 g in 1 TUBE; Type 0: Not a Combination Product11/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/14/2019
Labeler - CONE MEDICAL Co., Ltd. (695811691)
Registrant - CONE MEDICAL Co., Ltd. (695811691)
Establishment
NameAddressID/FEIBusiness Operations
HealingStory.,LTD.688403124manufacture(73527-0001)
Establishment
NameAddressID/FEIBusiness Operations
CONE MEDICAL Co., Ltd.695811691label(73527-0001)

Revised: 11/2023
Document Id: 0b6a912d-0982-03b4-e063-6394a90a3348
Set id: 9a567c9e-b8ce-7bf1-e053-2995a90aff2b
Version: 2
Effective Time: 20231130
 
CONE MEDICAL Co., Ltd.