DIO ENAMEL COATING PEN PRO TOOTH- tricalcium phosphate, dental type silica, tocopheryl acetate paste, dentifrice

DIO Enamel Coating Pen Pro Tooth by

Drug Labeling and Warnings

DIO Enamel Coating Pen Pro Tooth by is a Otc medication manufactured, distributed, or labeled by Dio Corporation, KMPharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tricalcium Phosphate, Dental Type Silica (Silicon Dioxide), Tocopheryl Acetate (.ALPHA.-TOCOPHEROL ACETATE)

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

1. Spin the lever at the bottom of the product clockwise
2. Rub the silicon tip smoothly on the sensitive area (60 seconds)
3. Rinse your mouth after 30 seconds once the product is absorbed)

WARNINGS

Alright container, store at room temperature (1-30)

INACTIVE INGREDIENT

Sorbitol, water, etc.

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIO ENAMEL COATING PEN PRO TOOTH 
tricalcium phosphate, dental type silica, tocopheryl acetate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75902-6001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	20 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.2 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75902-6001-1	5 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2016

Labeler - Dio Corporation (631085206)

Establishment
Name	Address	ID/FEI	Business Operations
KMPharmaceutical Co., Ltd.		688679158	manufacture(75902-6001)