ORAL PROJEQT O1 TOOTHPASTETABLETS- sodium fluoride tablet

ORAL PROJEQT O1 TOOTHPASTETABLETS by

Drug Labeling and Warnings

ORAL PROJEQT O1 TOOTHPASTETABLETS 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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAL PROJEQT O1 TOOTHPASTETABLETS 
sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76058-500
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 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	5 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	1 g
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	0.05 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	None
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76058-500-01	62 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	08/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2022

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(76058-500)