T-SERIES- sodium fluoride tablet 
SUNGWON PHARMACEUTICAL CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

sodium fluoride

INACTIVE INGREDIENT

silica, sodium pyrophosphate, pyridoxine hydrochloride, D-sorbitol, microcrystalline cellulose, xylitol, sodium bicarbonate, tea extract, tocopherol acetate, etc

PURPOSE

■ Keeps teeth white and strong

■ Keep the oral cavity clean

■ Prevents tooth decay and bad breath caused by fluoride

■ Removing plaque, preventing gingivitis and periodontitis

■ Periodontal Disease Prevention

■ Gum Disease Prevention

■ Prevention of tartar deposition

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNING

For oral use only
When using this product

■ This toothpaste has a 1,000 ppm fluoride content

■ Do not use other than brushing teeth and be careful not to swallow

Keep out of reach of children

■ if swallowed, get medical help or contact a person control center immediately

USES

for oral use only

INDICATION & USAGE SECTION

■ Within 3 times a day, chew 1 or 2 tablets sufficiently and then brush your teeth by brushing or brush your teeth by brushing them

■ scrub softly as like doing massage

label

T-SERIES 
sodium fluoride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76058-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeROUNDSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76058-001-0160 in 1 BOTTLE; Type 0: Not a Combination Product10/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/19/2019
Labeler - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)
Registrant - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)
Establishment
NameAddressID/FEIBusiness Operations
SUNGWON PHARMACEUTICAL CO., LTD.689787898manufacture(76058-001)

Revised: 10/2019
Document Id: 953e0b57-a59f-d70a-e053-2995a90a586b
Set id: 953e23ce-1c2f-103c-e053-2995a90a3947
Version: 1
Effective Time: 20191018
 
SUNGWON PHARMACEUTICAL CO., LTD.