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

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JUNI ESSENTIALS SOLIDTOOTHPASTE 
sodium fluoride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76058-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeROUNDSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76058-002-01180 in 1 POUCH; Type 0: Not a Combination Product07/29/202110/28/2021
2NDC: 76058-002-0230 in 1 PACKAGE; Type 0: Not a Combination Product07/29/202110/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/29/202110/28/2021
Labeler - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)
Registrant - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)
Establishment
NameAddressID/FEIBusiness Operations
SUNGWON PHARMACEUTICAL CO., LTD.689787898manufacture(76058-002)

Revised: 10/2021