DR.EL ORTHO CARE TOOTH- silicon dioxide, sodium monofluorophosphate paste, dentifrice

Dr.EL ORTHO CARE TOOTH by

Drug Labeling and Warnings

Dr.EL ORTHO CARE TOOTH by is a Otc medication manufactured, distributed, or labeled by Dr. EL CO., LTD., DONG IL PHARMS CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATE

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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

WARNINGS

(1)The toothpaste content of this toothpaste is 660 ppm.

(2) Do not swallow and rinse mouth thoroughly after use.

(3) If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.

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

(5) Consult a physician or dentist immediately if a child under 6 years old hasswallowed large quantities.

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.EL ORTHO CARE TOOTH 
silicon dioxide, sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72440-105
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 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: 72440-105-01	120 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
DONG IL PHARMS CO.,LTD		557810721	manufacture(72440-105)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. EL CO., LTD.		694771074	label(72440-105)