DR.NOAH SOLIDTOOTHPASTE- sodium fluoride tablet

Dr.NOAH SOLIDTOOTHPASTE by

Drug Labeling and Warnings

Dr.NOAH SOLIDTOOTHPASTE by is a Otc medication manufactured, distributed, or labeled by DR.Noah, SUNGWON PHARMACEUTICAL CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

INACTIVE INGREDIENT

D-Sorbitol,Microcrystalline Cellulose, Xylitol, Enzymatically Modified Stevia, Bamboo Salt, L-Menthol, CombinedFlavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Combined Flavor(SperamintFlavor Powder), Yuzu Extract, Chamomile Powder, Sodium Bicarbonate, Xanthan Gum,Hydroxypropylcellulose, Magnesium Stearate, Sodium Cocoyl Glutamate

PURPOSE

■ Keeps teeth white and strong

■ Keep the oral cavity clean

■ Prevents tooth decay and bad breath caused by fluoride

■ Removing plaque, preventing gingivitis and periodontitis

■ Periodontal Disease Prevention

■ Gum Disease Prevention

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNING

For oral use only
When using this product

■ Do not use other than brushing teeth and be careful not to swallow

Keep out of reach of children

■ if swallowed, seek medical help or contact the poison control center immediately

USES

for oral use only

INDICATION & USAGE SECTION

adults and children above the age of 6: chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as recommended by your doctor or dentist

do not swallow the tablet

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.NOAH SOLIDTOOTHPASTE 
sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82359-0003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.00154 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	0.035 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	0.007 g
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	0.00035 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82359-0003-1	180 in 1 POUCH; Type 0: Not a Combination Product	10/29/2021
2	NDC: 82359-0003-2	30 in 1 CASE; Type 0: Not a Combination Product	10/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/29/2021

Labeler - DR.Noah (695333875)

Registrant - DR.Noah (695333875)

Establishment
Name	Address	ID/FEI	Business Operations
SUNGWON PHARMACEUTICAL CO., LTD.		689787898	manufacture(82359-0003)

Establishment
Name	Address	ID/FEI	Business Operations
DR.Noah		695333875	label(82359-0003)