Juni Essentials SolidToothpaste by SUNGWON PHARMACEUTICAL CO., LTD.

Juni Essentials SolidToothpaste by

Drug Labeling and Warnings

Juni Essentials SolidToothpaste by is a Otc medication manufactured, distributed, or labeled by SUNGWON PHARMACEUTICAL CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JUNI ESSENTIALS SOLIDTOOTHPASTE- sodium fluoride tablet 
SUNGWON PHARMACEUTICAL CO., LTD.

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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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

■ This toothpaste has a 1,000 ppm fluoride content

■ 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

JUNI ESSENTIALS SOLIDTOOTHPASTE 
sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76058-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22

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: 76058-002-01	180 in 1 POUCH; Type 0: Not a Combination Product	07/29/2021	10/28/2021
2	NDC: 76058-002-02	30 in 1 PACKAGE; Type 0: Not a Combination Product	07/29/2021	10/28/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/29/2021	10/28/2021

Labeler - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)

Registrant - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)

Establishment
Name	Address	ID/FEI	Business Operations
SUNGWON PHARMACEUTICAL CO., LTD.		689787898	manufacture(76058-002)

Revised: 10/2021

Document Id: cf7ac496-3bf0-302e-e053-2a95a90a7554

34390-5

Set id: c838c135-2462-5bf5-e053-2a95a90a75f2

Version: 2

Effective Time: 20211029