Premium Whitening

Dosage form: gel, dentifrice
Ingredients: HYDROGEN PEROXIDE 35mL in 100mL
Labeler: Hankuk Bowonbio Co., Ltd
NDC Code: 60319-1001

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.

Drug Facts

active ingredient:  hydrogen peroxide solution

inactive ingredient: polyvinyl alcohol, povidone, sodium stannate, purified water

for dental care use

keep out of reach of the children

apply Proper Amount of the gel on the teeth.

■ For tooth only.
■ Avoid contact with eyes.
■ Do not swallow. If swallowed, get medical help.

dry the tooth to be applied

PREMIUM WHITENING 
hydrogen peroxide gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60319-1001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE35 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
POVIDONE 
SODIUM STANNATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:60319-1001-14.3 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/13/2011
Labeler - Hankuk Bowonbio Co., Ltd (690045133)
Registrant - Hankuk Bowonbio Co., Ltd (690045133)
Establishment
NameAddressID/FEIOperations
Hankuk Bowonbio Co., Ltd690045133manufacture

Revised: 09/2011
 
Hankuk Bowonbio Co., Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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