FLUORIDE BITS- sodium monofluorophosphate 0.76% tablet 
The Kind Lab, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BITE TOOTHPASTE FLUORIDE TOOTHPASTE BITS

Sodium Monofluorophosphate 0.76 % (0.14 % w/w fluoride ion)

Anticavity

Helps protect against dental cavities

If more than used for brushing is accidentally swallowed, get medical help or contact Poison Control Center right away. Keep away from pets.

Keep out of reach of childrenunder 6 years of age.

Adult:

Wet your toothbrush and place one (1) toothpaste bit in your mouth and bite down. Brush teeth thoroughly preferably after each meal or at least twice daily or as directed by a dentist or physician.

Rinse after using.

Do not swallow.

Calcium Carbonate, Colloidal Silicon Dioxide, Guar Gum, Magnesium Stearate, Menthol, Natural Flavor (Peppermint), Sodium Bicarbonate, Sodium Cocoyl Glutamate, Starch, Xylitol, Zinc Citrate.

Store at room temperature and in a dry place

BiteToothpaste.com

Package Label

FLUORIDE BITS 
sodium monofluorophosphate 0.76% tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82976-101
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 
Inactive Ingredients
Ingredient NameStrength
GUAR GUM (UNII: E89I1637KE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ZINC CITRATE (UNII: K72I3DEX9B)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MENTHOL (UNII: L7T10EIP3A)  
PEPPERMINT (UNII: V95R5KMY2B)  
XYLITOL (UNII: VCQ006KQ1E)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
Product Characteristics
Colorwhite (WHITE TO OFF WHITE) Scorescore with uneven pieces
ShapeROUNDSize6mm
FlavorMINTImprint Code z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82976-101-00124 in 1 POUCH; Type 0: Not a Combination Product05/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/19/2023
Labeler - The Kind Lab, Inc. (117339209)

Revised: 5/2023
Document Id: fb711520-65dd-35d7-e053-6294a90a0ef8
Set id: fa433031-7376-0e5b-e053-6394a90a5f75
Version: 2
Effective Time: 20230519
 
The Kind Lab, Inc.