DR.EL BERRYGOOD TOOTH- silica, sodiuoroum monoflphosphate, tocopheryl acetate, hydrated silica paste, dentifrice

Dr.EL BERRYGOOD TOOTH by

Drug Labeling and Warnings

Dr.EL BERRYGOOD 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]

ACTIVE INGREDIENT

Sodium Monofluorosphate 0.38%

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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

WARNINGS

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72440-108
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: 72440-108-01	75 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019

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

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(72440-108)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. EL CO., LTD.		694771074	label(72440-108)