KINDFILL- cinnamon toothpaste tablets tablet, chewable 
Make USA LLC

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.

----------

MAKE USA- BYHUMANKIND: Cinnamon Flavor

Active Ingredient(s)

Sodium Fluoride .62mg (28 mg flouride ion)

Purpose

Anti-cavity

Use

aids in the prevention of dental cavities

Warnings

When using this product, if irritation or sensitivity occurs discontinue use.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Store at 25-30°C (68-77°F). Protect from excessive moisture.

Inactive ingredients

Microcrystalline Cellulose, Sodium bicarbonate (Baking Soda), Silica, Sodium Lauryl Glutamate, Magnesium Stearate, Xanthan Gum, Stevia (Stevioside), Citric Acid

Package Label - Principal Display Panel

60 in Each Box NDC: 80486-113-1160 in Each Box NDC: 80486-113-11

KINDFILL 
cinnamon toothpaste tablets tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80486-113
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.62 mg  in 312 mg
Inactive Ingredients
Ingredient NameStrength
STEVIA LEAF (UNII: 6TC6NN0876)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINT (UNII: FV98Z8GITP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorCINNAMONImprint Code NONE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80486-113-1160 in 1 BOX09/29/2021
1312 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/29/2021
Labeler - Make USA LLC (110142615)
Establishment
NameAddressID/FEIBusiness Operations
Make USA LLC110142615repack(80486-113)
Establishment
NameAddressID/FEIBusiness Operations
Denttabs GmbH340109625manufacture(80486-113)

Revised: 9/2021
Document Id: cd1f9677-cb02-9ad1-e053-2a95a90afe41
Set id: cd1f9677-cb01-9ad1-e053-2a95a90afe41
Version: 2
Effective Time: 20210929
 
Make USA LLC