ORAL PROJEQT O1 TOOTHPASTETABLETS- sodium fluoride tablet 
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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ACTIVE INGREDIENT

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

INACTIVE INGREDIENT

D-Sorbitol, Microcrystalline Cellulose, Sodium Chloride, Xylitol, Enzymatically Modified Stevia, Sodium Cocoyl Glutamate, GreenTea Flavor Powder, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Peppermint Flavor Powder), L-Menthol, Lemon Juice, Aloe Extract Powder, Tea Extract, Hydroxyapatite, Xanthan Gum, Hydroxypropylcellulose, Sodium Bicarbonate, Magnesium Stearate

PURPOSE

Helps protect against cavities and freshen breath.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNING

Keep out of reach of children Under 6 years of age.
If more than used for brushing is accidentally swallowed, get
medical help or contact a Poison Control Center immediately.
This toothpaste contains 1000ppm of fluorine.
If children under 6 years of age swallowed an over dose, get
medical help or contact a Poison Control Center immediately.

USES

for oral use only

INDICATION & USAGE SECTION

Adults and children 6 years of age and older

Literally chew a tablet then brush teeeth thoroughly,
preferably after each meal or at least twice a day, every day,
or as directed by a dentist or physician.
DO NOT swallow a tablet.
Children under 6 years of age: Consult a dentist or doctor.

1

ORAL PROJEQT O1 TOOTHPASTETABLETS 
sodium fluoride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76058-500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE5 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE1 g
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE0.05 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76058-500-0162 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2022
Labeler - Sungwon Pharmaceutical Co., Ltd. (689787898)
Registrant - Sungwon Pharmaceutical Co., Ltd. (689787898)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(76058-500)

Revised: 8/2022
Document Id: e6de7e90-4789-18dc-e053-2995a90a63d5
Set id: e6de7e8a-08c8-962f-e053-2995a90aee46
Version: 1
Effective Time: 20220822
 
Sungwon Pharmaceutical Co., Ltd.