INNOBLE ONECHEWTOOTHPASTE- sodium fluoride tablet

Innoble ONECHEWTOOTHPASTE by

Drug Labeling and Warnings

Innoble ONECHEWTOOTHPASTE by is a Otc medication manufactured, distributed, or labeled by livmate, 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, Sodium Cocoyl Glutamate, Sodium Cocoyl Isethionate, Microcrystalline Cellulose, Xylitol, Magnesium Stearate, Sodium Bicarbonate, Xanthan Gum, Hydroxypropylcellulose, Enzymatically Modified Stevia, L-Menthol, Bamboo Salt, Sodium Chloride, DL-Malic Acid, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Coconut Oil, Aloe Vera Gel, Carrot Extract, Calendula Extract

PURPOSE

Anti plaque

Tartar Control

Anti Cavity

Against gum disease

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNING

Do not use for children under 6 years of age.

Directions

Adults and children 6 years of age and older; Gently chew 1 tablet until it crushed. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

INDICATION & USAGE SECTION

Prevention of cavities, plaque, gum disease, gingivitis and periodontal disease.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INNOBLE ONECHEWTOOTHPASTE 
sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82709-001
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 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	5 g  in 100 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	1 g  in 100 g
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	0.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
XYLITOL (UNII: VCQ006KQ1E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
LEVOMENTHOL (UNII: BZ1R15MTK7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MALIC ACID (UNII: 817L1N4CKP)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARROT (UNII: L56Z1JK48B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82709-001-01	84 g in 1 POUCH; Type 0: Not a Combination Product	05/03/2022
2	NDC: 82709-001-03	1 in 1 CARTON	05/03/2022
2	NDC: 82709-001-02	42 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/03/2022

Labeler - livmate (987587873)

Registrant - livmate (987587873)

Establishment
Name	Address	ID/FEI	Business Operations
SUNGWON PHARMACEUTICAL CO., LTD.		689787898	manufacture(82709-001)