UNPASTE TOOTH TABS- zero waste replacement for toothpaste tablet, chewable
Denttabs GmbH

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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Unpaste Tooth Tabs-Cinnamon 2021

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, Xanthan Gum, Stevia (Stevioside), Citric Acid

Package Label - Principal Display Panel

NDC: 74087-113-01

PLastic Free 100% Natural

2 Months Supply

UNPASTE TOOTH TABS

A zero-waste replacement for your toothpaste

125 TABS Contains Flouride POIDS Net 39G

Made in Germany

UNPASTE TOOTH TABS
zero waste replacement for toothpaste tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74087-113
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 in 312 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)
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:74087-113-01	125 in 1 PACKET	09/23/2021
1		312 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC:74087-113-10	10000 in 1 CARTON	09/23/2021
2		312 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/23/2021	09/23/2021

Labeler - Denttabs GmbH (340109625)

Name	Address	ID/FEI	Business Operations
Establishment
Denttabs GmbH		340109625	manufacture(74087-113)

Revised: 9/2021

Document Id: cca5c3bc-fa98-3b45-e053-2a95a90afe73

Set id: cca5b31a-8363-2af4-e053-2995a90a219a

Version: 2

Effective Time: 20210923

Denttabs GmbH