DIO WHITENING- sodium fluoride paste, dentifrice

DIO WHITENING by

Drug Labeling and Warnings

DIO WHITENING 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

colloidal silicon dioxide, tocopherol acetate, 35% hydrogen peroxide solution

INACTIVE INGREDIENT

xylityl, sorbitol solution 70%, polyethylene glycol 1500, carboxymethylcellulose sodium, xanthan gum, poly vinyl pirrolidone, sodium stannate, etc.

PURPOSE

for dental care

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

brush teeth with your toothbrush

WARNINGS

store at room temperature

DOSAGE & ADMINISTRATION

for dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIO WHITENING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75902-4001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	7 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	0.2 g  in 100 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.14 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: 75902-4001-1	90 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/22/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/22/2015

Labeler - Dio Corporation (631085206)

Registrant - Dio Corporation (631085206)

Establishment
Name	Address	ID/FEI	Business Operations
KMPharmaceutical Co., Ltd.		688679158	manufacture(75902-4001)