T-SERIES- sodium fluoride tablet

T-SERIES by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

T-SERIES 
sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76058-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76058-001-01	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/19/2019

Labeler - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)

Registrant - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)

Establishment
Name	Address	ID/FEI	Business Operations
SUNGWON PHARMACEUTICAL CO., LTD.		689787898	manufacture(76058-001)