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%
(1010 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 extract, hydroxyapatite, Lingusticum wallichii, mugwort extract, water

Questions or Comments?

call +82(53)584 3320

 

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

DENTREE 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76170-101
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 1000 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)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76170-101-5050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/2012
Labeler - E-SOUP Co., Ltd. (557805059)
Establishment
NameAddressID/FEIBusiness Operations
E-SOUP Co Ltd557805059manufacture(76170-101)

Revised: 4/2020
Document Id: a3be7b7e-f78d-168b-e053-2a95a90a4b15
Set id: ede7caf8-0384-9d2b-83b8-a88c38a66a11
Version: 2
Effective Time: 20200420
 
E-SOUP Co., Ltd.