FLUORIDE- sodium fluoride tablet 
Mintly 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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Toothpaste tablets with fluoride

Drug Facts

Active ingredient

Sodium fluoride 0.21% (0.30 mg fluoride ion)

Purpose

Anticavity toothpaste

Use

Aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Store at 68-77°F (20-25°C).

Protect from excessive moisture.

Inactive ingredients

microcrystalline cellulose, sodium bicarbonate, silica, sodium lauroyl glutamate, magnesium stearate, natural mint flavor, menthol, xanthan gum, stevioside, citric acid

Questions?

Call 888-478-6710

DIST. BY MINTLY INC., PRINCETON, NJ 08540

PRINCIPAL DISPLAY PANEL - 240 Tablet Jar Label

mintly

TOOTHPASTE
TABLETS

with fluoride

NATURAL MINT

240
TABLETS

2.6 OZ (74.9g)

Principal Display Panel - 240 Tablet Jar Label
FLUORIDE 
sodium fluoride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82149-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium Fluoride0.6552 mg
Inactive Ingredients
Ingredient NameStrength
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Sodium Bicarbonate (UNII: 8MDF5V39QO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Sodium Lauroyl Glutamate (UNII: NCX1UU2D33)  
Magnesium Stearate (UNII: 70097M6I30)  
Mint (UNII: FV98Z8GITP)  
MENTHOL, (+)- (UNII: C6B1OE8P3W)  
Xanthan Gum (UNII: TTV12P4NEE)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize9mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82149-001-0160 in 1 JAR; Type 0: Not a Combination Product08/30/2021
2NDC:82149-001-02240 in 1 JAR; Type 0: Not a Combination Product08/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/30/2021
Labeler - Mintly Inc. (118220595)

Revised: 11/2022
Document Id: 18656ae0-bd97-4a3a-8025-b23c16533352
Set id: 4deac778-cb95-4c81-b3d7-ead8d956b312
Version: 3
Effective Time: 20221116
 
Mintly Inc.