INNOBLE ONECHEWTOOTHPASTE- sodium fluoride tablet 
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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, 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.

label

INNOBLE ONECHEWTOOTHPASTE 
sodium fluoride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82709-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE5 g  in 100 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE1 g  in 100 g
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82709-001-0184 g in 1 POUCH; Type 0: Not a Combination Product05/03/2022
2NDC:82709-001-031 in 1 CARTON05/03/2022
2NDC:82709-001-0242 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/03/2022
Labeler - livmate (987587873)
Registrant - livmate (987587873)
Establishment
NameAddressID/FEIBusiness Operations
SUNGWON PHARMACEUTICAL CO., LTD.689787898manufacture(82709-001)

Revised: 5/2022
Document Id: de341dbd-eeef-2e74-e053-2995a90ad220
Set id: a8cedb67-afe9-4bc5-94fe-f1358281f4f7
Version: 1
Effective Time: 20220504
 
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