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

Mint 125 125 tabs, NDC: 74355-555-12

UNPASTE
zero waste fluoride mint tooth tabs tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74355-555
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74355-555-11	10 in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2024
2	NDC:74355-555-12	125 in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2024
3	NDC:74355-555-13	10000 in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2024
4	NDC:74355-555-14	380000 in 1 DRUM; Type 0: Not a Combination Product	04/01/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	04/01/2024

Labeler - Avespan LLC (117415511)

Name	Address	ID/FEI	Business Operations
Establishment
Spreewlder Arzneimittel GmbH		332313084	manufacture(74355-555)

Avespan-Spree Mint 2024