LUZEN WHITENING GEL- hydrogen peroxide gel

Luzen Whitening Gel by

Drug Labeling and Warnings

Luzen Whitening Gel by is a Otc medication manufactured, distributed, or labeled by BIOSTECH CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

hyeroge peroxide

DOSAGE & ADMINISTRATION

for external use only

PURPOSE

oral debriding

INDICATIONS & USAGE

Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

INACTIVE INGREDIENT

water, glycerin, peg400, ethanol, pvp k29/32(povidone), pvp k90(povidone), aerosil 200, flavor, etc

KEEP OUT OF REACH OF CHILDREN

Keep out of children

WARNINGS

for external use only

keep out of reach children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUZEN WHITENING GEL 
hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70812-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
XYLITOL (UNII: VCQ006KQ1E)
ERYTHRITOL (UNII: RA96B954X6)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70812-010-01	4 g in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/23/2020

Labeler - BIOSTECH CO., LTD. (687294330)

Registrant - BIOSTECH CO., LTD. (687294330)

Establishment
Name	Address	ID/FEI	Business Operations
BIOSTECH CO., LTD.		687294330	manufacture(70812-010)