DIO WHITENING- sodium fluoride paste, dentifrice 
Dio Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

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


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

for dental care



keep out of reach of the children

brush teeth with your toothbrush



store at room temperature


for dental use only

package label
DIO WHITENING 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75902-4001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE7 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL0.2 g  in 100 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75902-4001-190 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/22/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/22/2015
Labeler - Dio Corporation (631085206)
Registrant - Dio Corporation (631085206)
Establishment
NameAddressID/FEIBusiness Operations
KMPharmaceutical Co., Ltd.688679158manufacture(75902-4001)

Revised: 6/2017
Document Id: 50e23c08-7305-6d1a-e054-00144ff8d46c
Set id: 1b5a5f59-fa6a-4ce6-a360-502fb651eb1a
Version: 2
Effective Time: 20170601
 
Dio Corporation