Drug Facts

PREMIUM WHITENING- hydrogen peroxide gel, dentifrice
Hankuk Bowonbio Co., Ltd

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

active ingredient: hydrogen peroxide solution
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inactive ingredient: polyvinyl alcohol, povidone, sodium stannate, purified water
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for dental care use
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keep out of reach of the children
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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	35 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60319-1001-1	4.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/13/2011

Labeler - Hankuk Bowonbio Co., Ltd (690045133)

Registrant - Hankuk Bowonbio Co., Ltd (690045133)

Name	Address	ID/FEI	Business Operations
Establishment
Hankuk Bowonbio Co., Ltd		690045133	manufacture(60319-1001)