DR.EL DOUX TOOTH- silicon dioxide paste, dentifrice 
Dr. EL CO., LTD.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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SILICON DIOXIDE

For dental care

Keep out of reach of children

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years: Ask a dentist or physician

(1) Do not swallow and rinse mouth thoroughly after use

(2) If you experience any problems with your gums or mouth during use,

discontinue use and consult your doctor.

(3) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.

(4) Consult a physician or dentist immediately if a child under 6 years old has

swallowed large quantities.

(5) Keep out of the reach of children under 6 years of age.

D-Sorbitol Solution, Water, Concentrated Glycerin, Xantangum, Sodium Cocoyl Glutamate, Raspberry Flavor, Black Current Flavor, Xylitol, Chitosan, Rosemary Extract, Matricaria Extract, Eucalyptus Extract, Sage Extract, Aloe Extract, Green Tea Extract, Ascorbic Acid, Tocopherol Acetate

For dental use only

1

DR.EL DOUX TOOTH 
silicon dioxide paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72440-103
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72440-103-0160 g in 1 TUBE; Type 0: Not a Combination Product08/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2019
Labeler - Dr. EL CO., LTD. (694771074)
Registrant - Dr. EL CO., LTD. (694771074)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO.,LTD557810721manufacture(72440-103)
Establishment
NameAddressID/FEIBusiness Operations
Dr. EL CO., LTD.694771074label(72440-103)

Revised: 9/2019
Document Id: 935b14dd-8cdd-c9ca-e053-2a95a90a71f0
Set id: 935b3d27-4dbf-0a56-e053-2995a90abc1e
Version: 1
Effective Time: 20190925
 
Dr. EL CO., LTD.