UNPASTE- zero waste fluoride mint tooth tabs tablet, chewable 
Avespan 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.

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Avespan-Farmina Mint 2022

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

68984-112-01

125 tabs, NDC: 74355-222-01

UNPASTE 
zero waste fluoride mint tooth tabs tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74355-222
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)  
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:74355-222-01125 in 1 PACKET12/01/2022
1312 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:74355-222-0210000 in 1 CARTON12/01/2022
2312 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product
3NDC:74355-222-0310 in 1 PACKET12/01/2022
3312 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 finalpart35512/01/2022
Labeler - Avespan LLC (117415511)
Establishment
NameAddressID/FEIBusiness Operations
Farmina sp. z o.o., Zaklad w Myslenicach 849477431manufacture(74355-222)

Revised: 11/2022
Document Id: ee8f081f-f785-8f93-e053-2995a90ada0f
Set id: ee8f081f-f786-8f93-e053-2995a90ada0f
Version: 1
Effective Time: 20221128
 
Avespan LLC