PREMIUM WHITENING- hydrogen peroxide gel, dentifrice

Premium Whitening by

Drug Labeling and Warnings

Premium Whitening by is a Otc medication manufactured, distributed, or labeled by Hankuk Bowonbio Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredient: hydrogen peroxide solution
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INACTIVE INGREDIENT

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

for dental care use
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KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children
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INDICATIONS & USAGE

apply Proper Amount of the gel on the teeth.

WARNINGS

■ For tooth only.

■ Avoid contact with eyes.

■ Do not swallow. If swallowed, get medical help.

DOSAGE & ADMINISTRATION

dry the tooth to be applied

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIUM WHITENING 
hydrogen peroxide gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60319-1001
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POVIDONE (UNII: FZ989GH94E)
SODIUM STANNATE (UNII: NJ7C1V83KG)
WATER (UNII: 059QF0KO0R)

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

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

Labeler - Hankuk Bowonbio Co., Ltd (690045133)

Registrant - Hankuk Bowonbio Co., Ltd (690045133)

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