Farmina-Avespan Mint 2022

Unpaste by

Drug Labeling and Warnings

Unpaste by is a Otc medication manufactured, distributed, or labeled by Farmina sp. z.o.o.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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Farmina-Avespan 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.
• Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

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

• Adults and children 6 years of age and older; chew one tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
• Do not swallow the tablet.
• Supervise children under 6 years of age for brushing and rinsing.

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

125 tabs, NDC: 68984-112-01

UNPASTE 
zero waste fluoride mint tooth tabs tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68984-112
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.62 mg  in 312 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor	PEPPERMINT	Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68984-112-01	125 in 1 PACKET	01/10/2022	01/11/2022
1		312 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 68984-112-02	10000 in 1 CARTON	01/10/2022	01/11/2022
2		312 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M021	01/10/2022	01/11/2022

Labeler - Farmina sp. z.o.o. (422254391)

Establishment
Name	Address	ID/FEI	Business Operations
Farmina sp. z.o.o.		849477431	manufacture(68984-112)

Revised: 11/2023

Document Id: 2cda568e-9b37-4c13-ab7a-54703e894cdf

34390-5

Set id: d52a8026-fff7-70d5-e053-2995a90a4c53

Version: 2

Effective Time: 20231130