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 children under 6 yrs 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 atleast 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

82976-100-00 82976-100-02

FLUORIDE BITS 
sodium monofluorophosphate 0.76% tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82976-100
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
XYLITOL (UNII: VCQ006KQ1E)  
MENTHOL (UNII: L7T10EIP3A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
PEPPERMINT (UNII: V95R5KMY2B)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ZINC CITRATE (UNII: K72I3DEX9B)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GUAR GUM (UNII: E89I1637KE)  
Product Characteristics
Colorwhite (White to Off White) Scorescore with uneven pieces
ShapeROUNDSize6mm
FlavorMINTImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82976-100-02124 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/06/2022
2NDC:82976-100-00124 in 1 POUCH; Type 0: Not a Combination Product12/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/06/2022
Labeler - The Kind Lab, Inc. (117339209)

Revised: 5/2023
Document Id: fc0f7f01-2ca4-9b72-e053-6394a90aa39a
Set id: eedf13dc-a009-027a-e053-2995a90a8ec8
Version: 3
Effective Time: 20230519
 
The Kind Lab, Inc.