Unpaste by PTG Lohnabfuellung GmbH PTG-Avespan Mint 2023

Unpaste by

Drug Labeling and Warnings

Unpaste by is a Otc medication manufactured, distributed, or labeled by PTG Lohnabfuellung GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UNPASTE- zero waste fluoride mint tooth tabs tablet, chewable 
PTG Lohnabfuellung 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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PTG-Avespan Mint 2023

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: 83406-122-02

UNPASTE 
zero waste fluoride mint tooth tabs tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83406-122(NDC: 68984-122)
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

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: 83406-122-01	10 in 1 PACKAGE; Type 0: Not a Combination Product	05/01/2023
2	NDC: 83406-122-02	125 in 1 PACKAGE; Type 0: Not a Combination Product	05/01/2023
3	NDC: 83406-122-03	10000 in 1 PACKAGE; Type 0: Not a Combination Product	05/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/01/2023

Labeler - PTG Lohnabfuellung GmbH (331962873)

Establishment
Name	Address	ID/FEI	Business Operations
PTG Lohnabfuellung GmbH		331962873	repack(83406-122) , relabel(83406-122)

Revised: 5/2023

Document Id: fa9e93dc-7249-49ba-e053-6394a90a7d4e

34390-5

Set id: fa9e93dc-7248-49ba-e053-6394a90a7d4e

Version: 1

Effective Time: 20230501