DOCTOR EL BLACK WHITE TOOTH- sodium monofluorophosphate paste, dentifrice

Doctor EL Black White Tooth by

Drug Labeling and Warnings

Doctor EL Black White 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 MONOFLUOROPHOSPHATE

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: 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

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

Sorbitol, Water, Hydrated Silica, Silica, Glycerin, Flavor, Sodium Citrate,

Cellulose Gum, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate,

Menthol, Charcoal Powder.,Carrageenan, Xanthan Gum, Sodium Saccharin,

Sodium Benzoate, Tocopheryl Acetate, Xylitol, Camellia Sinensis Leaf Extract,

Juglans Regia (Walnut) Shell Powder, Sodium Bicarbonate, Calendula Officinalis Extract, Chamomilla Recutita (Matricaria) Extract, Magnolia Officinalis Bark Extract

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCTOR EL BLACK WHITE TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72440-110
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.38 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: 72440-110-01	120 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/01/2020

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(72440-110)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. EL CO., LTD.		694771074	label(72440-110)