DENTREE- sodium fluoride gel, dentifrice 
E-SOUP 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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Drug Facts

Active Ingredient

Sodium fluoride-------------------0.22%
(1000 ppm of fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities, reducing halitosis, and tooth whitening

Warnings

keep out of reach of children.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older

Brushless: shake the container before pumping 2-3 times on a toothbrush to brush the teeth or into mouth for close-mouthed; gurgle the foam inside the mouth for about 30 seconds. Rinse off the residue with clean water several times to achieve the intended cleanliness.

With Brush: after gurgle the foam inside the mouth for about 30 seconds, you may use toothbrush to clean before rinse.

Children under 6 years old
ask a dentist or physician

Other Information

store at room temperature.

Inactive Ingredients

Allantoin, Ginger, Tribasic Calcium Phosphate, Lingusticum Wallichii Whole, Artemisia princeps leaf, water

Questions or Comments?

call +82(53)584 3320

 

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAYL PANELE-SOUP



NDC 76170-103-02



Dentree

Green Foaming Toothpaste



• Cavity Prevention



• Halitosis Reduction



• Tooth Whitening



50ml



Lot No. / Expiration Date



E-SOUP Co., Ltd. Rm 333 R&D Center,

Daegu Techno Park venture Factory, 62

Seongseo Gongdan-ro 11-gil, Dalseo-gu,

Daegu, KOREA 704-948



Made in Korea

Label

DENTREE 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76170-103
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
GINGER (UNII: C5529G5JPQ)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
LIGUSTICUM WALLICHII WHOLE (UNII: 8Y1N3NX2DW)  
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76170-103-011 in 1 CARTON12/01/2012
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:76170-103-021 in 1 CARTON12/01/2012
250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:76170-103-031 in 1 CARTON12/01/2012
3100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/2012
Labeler - E-SOUP Co., Ltd. (557805059)
Establishment
NameAddressID/FEIBusiness Operations
E-SOUP Co., Ltd557805059manufacture(76170-103)

Revised: 4/2020
Document Id: a3bec0bb-11b2-389a-e053-2a95a90ac303
Set id: d6cbadfc-693a-45f7-a154-5e4ddf051613
Version: 2
Effective Time: 20200420
 
E-SOUP Co., Ltd.