TOOTH- toothpaste tablets tablet 
Henan Dailygreen Biotechnology Co. LTD

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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83861-001

Active ingredient

sodium monofluorophosphate 0.877% (1100ppm w/v fluoride ion )

Purpose

Anticavity Toothpaste

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children Not to be used by children under 12 years of age. If more than used for brushing isaccidentally swallowed get medical help or contact a Poison Control Center right away.

Not to be used by children under 12 years of age .

n/a

n/a

Keep out of reach of children

Directions

Adults : Wet your toothbrush and crush the tab between your teeth Brush like normal. Rinse after using . Brushteeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow

Other Information

Store at room temperature and dry place.

Inactive ingredients

Sorbitol , Calcium Carbonate , Probiotics , Xylitol , Magnesium Stearate , Stevia Rebaudiana Extract ,Tea ( Camellia Sinensis ) Polyphenols , Peppermint ( Mentha Piperita ) oil , Bitter Orange ( Citrus Aurantium ) Flower Oil , Peppermint ( Mentha Piperita ) Leaf oil , Cocamidopropyl Betaine

83861-001-01

TOOTH 
toothpaste tablets tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83861-001
Route of AdministrationPERIODONTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.877 g  in 100 
Inactive Ingredients
Ingredient NameStrength
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
XYLITOL (UNII: VCQ006KQ1E)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SORBITOL (UNII: 506T60A25R)  
MENTHA SPICATA OIL (UNII: C3M81465G5)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeROUNDSize20mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83861-001-016 in 1 BOX12/11/2023
1NDC:83861-001-0260 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/11/2023
Labeler - Henan Dailygreen Biotechnology Co. LTD (699305250)
Registrant - Henan Dailygreen Biotechnology Co. LTD (699305250)
Establishment
NameAddressID/FEIBusiness Operations
Henan Dailygreen Biotechnology Co. LTD699305250manufacture(83861-001)

Revised: 12/2023
Document Id: 0c389ae5-8708-7ded-e063-6394a90a3945
Set id: 0c32911a-4029-01d8-e063-6294a90a9a90
Version: 2
Effective Time: 20231211
 
Henan Dailygreen Biotechnology Co. LTD