ONETOOTHCLINIC TOOTH by SUNGWON PHARMACEUTICAL CO., LTD.

ONETOOTHCLINIC TOOTH by

Drug Labeling and Warnings

ONETOOTHCLINIC TOOTH by is a Otc medication manufactured, distributed, or labeled by SUNGWON PHARMACEUTICAL CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

  • 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.

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: 76058-010
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: 76058-010-01100 g in 1 TUBE; Type 0: Not a Combination Product11/14/201912/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/14/201912/19/2019
Labeler - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)
Registrant - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)
Establishment
NameAddressID/FEIBusiness Operations
SUNGWON PHARMACEUTICAL CO., LTD.689787898manufacture(76058-010)

Revised: 12/2019
Document Id: 9a565575-14aa-55fe-e053-2995a90a48be
Set id: 97a9a851-232e-3594-e053-2995a90a809d
Version: 2
Effective Time: 20191222
 
SUNGWON PHARMACEUTICAL CO., LTD.