DR.EL Very Good Tooth by Dr. EL CO., LTD. / Green Wonil Co., Ltd

DR.EL Very Good Tooth by

Drug Labeling and Warnings

DR.EL Very Good Tooth by is a Otc medication manufactured, distributed, or labeled by Dr. EL CO., LTD., Green Wonil Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR.EL VERY GOOD TOOTH- silica, sodiuoroum monoflphosphate, tocopheryl acetate, hydrated silica 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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Sodium Monofluorosphate 0.38%

For dental care

Keep out of reach of children

Supervise children as necessary until capable of using without Supervision.

Adults and children 6 years of age and older: Bursh 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 swallpwing)

Children under 2 years: Ask a dentist or physician

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Silica, Tocopheryl Acetate, Sorbitol, Glycerin, PEG-32, Hydrated Silica, Sodium Saccharin, Xylitol, Sodium Benzoate, Erythritol, Calcium Glycerophosphate, Rubus Idaeus (Raspberry) Fruit Extract, Camellia Sinensis Leaf Extract, Calendula Officinalis Extract, Sodium Lauryl Sulfate, Cellulose Gum, Xanthan Gum, Flavor, Menthol, Water

For dental use only

DR.EL VERY GOOD TOOTH 
silica, sodiuoroum monoflphosphate, tocopheryl acetate, hydrated silica paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72440-101
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9) (HYDRATED SILICA - UNII:Y6O7T4G8P9)	HYDRATED SILICA	10 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.09 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	5 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.38 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72440-101-01	75 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2019	09/01/2019

Labeler - Dr. EL CO., LTD. (694771074)

Registrant - Dr. EL CO., LTD. (694771074)

Establishment
Name	Address	ID/FEI	Business Operations
Green Wonil Co., Ltd		688442099	manufacture(72440-101)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. EL CO., LTD.		694771074	label(72440-101)

Revised: 9/2019

Document Id: 936f528e-945d-04ca-e053-2a95a90a442b

34390-5

Set id: 93589dc1-69d8-4c66-e053-2a95a90ac17c

Version: 2

Effective Time: 20190926