Luzen Whitening Gel

Manufacturer: BIOSTECH CO., LTD.
Effective date: 2020-12-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:35:47

Label at a glance#

ProductLuzen Whitening Gel

Active ingredientHYDROGEN PEROXIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

hyeroge peroxide

DOSAGE & ADMINISTRATION SECTION

for external use only

OTC - PURPOSE SECTION

oral debriding

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of children

WARNINGS SECTION

for external use only

keep out of reach children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70812-010-01	2022-07-29	C162847	48780-1	e4f33bdf-af90-d8a0-e053-dadaa90a6e4e	b71ab404-1d5c-f9e9-e053-2995a90ae226

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70812-010-01	Luzen Whitening Gel	4 g in 1 BOTTLE	GEL	4		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70812-010	LUZEN WHITENING GEL (HYDROGEN PEROXIDE) GEL [BIOSTECH CO., LTD.]	1	Legacy NDC, 1 package rows	20201224_b71ab404-1d5c-f9e9-e053-2995a90ae226.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Luzen Whitening Gel
Hydrogen Peroxide
WATER
GLYCERIN
ALCOHOL
SILICON DIOXIDE
CITRIC ACID MONOHYDRATE
POLYSORBATE 80
XYLITOL
ERYTHRITOL
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70812-010	70812-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
ALCOHOL	3K9958V90M	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
XYLITOL	VCQ006KQ1E	IACT
ERYTHRITOL	RA96B954X6	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
HYDROGEN PEROXIDE	BBX060AN9V	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b71a9777-83ef-3cc2-e053-2995a90a3c08			b71ab404-1d5c-f9e9-e053-2995a90ae226	2020-12-22	Warnings	Exact identifier spl id: b71a9777-83ef-3cc2-e053-2995a90a3c08 spl set id: b71ab404-1d5c-f9e9-e053-2995a90ae226

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.