UNPASTE- zero waste fluoride mint tooth tabs tablet, chewable 
Farmina sp. z.o.o.

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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Farmina Mint Tabs

Active Ingredient(s)

Sodium Fluoride 0.62mg (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, Natural Mint Flavor, Menthol, Xanthan Gum, Stevia (Stevioside), Citric Acid

Package Label - Principal Display Panel

Bulk Label Mint 04

120kg drum, NDC: 68984-122-04

UNPASTE 
zero waste fluoride mint tooth tabs tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68984-122
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.62 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)  
MENTHOL, (+)- (UNII: C6B1OE8P3W)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorPEPPERMINTImprint Code NONE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68984-122-04380000 in 1 DRUM; Type 0: Not a Combination Product12/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/10/2022
Labeler - Farmina sp. z.o.o. (422254391)
Establishment
NameAddressID/FEIBusiness Operations
Farmina sp. z o.o., Zaklad w Myslenicach849477431manufacture(68984-122)

Revised: 5/2023
Document Id: fb3e3520-7412-7e8e-e053-6294a90ae0cc
Set id: ee8eb995-5d7f-2ecd-e053-2a95a90af04a
Version: 4
Effective Time: 20230504
 
Farmina sp. z.o.o.