Pro Brighten Tooth whitening Gel

Manufacturer: Sangleaf Pharm., Co Ltd
Effective date: 2016-07-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:46:31

Label at a glance#

ProductPro Brighten Tooth whitening Gel

Active ingredientHydrogen Peroxide

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 3.00%

OTC - PURPOSE SECTION

Oral Debriding

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Use up to 3 times daily after meals and at bedtime

children under 12 years of age: should be supervised in the use

children under 2 years of age: consult a dentist, doctor

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

The condition persists or gets worse

Sore mouth symptoms do not improve in 7 days

Irritation, pain or redness persists or worsens

Swelling, rash or fever develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT SECTION

Carbomer, Propylene glycol, Potassium Phosphate tribasic, Titanium dioxide, Purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70810-001-02	2020-01-31	C162847	48780-1	9d75b9d0-f166-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70810-001-01	Pro Brighten Tooth whitening Gel	100 g in 1 TUBE	GEL	100		1
70810-001-02	Pro Brighten Tooth whitening Gel	1 in 1 CARTON	GEL	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70810-001	PRO BRIGHTEN TOOTH WHITENING GEL (HYDROGEN PEROXIDE) GEL [SANGLEAF PHARM., CO LTD]	1	Legacy NDC, 2 package rows	20160709_5b0c140c-33bf-48b4-9f1e-10fa674c1ee6.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Pro Brighten Tooth whitening Gel
Hydrogen Peroxide
CARBOXYPOLYMETHYLENE
PROPYLENE GLYCOL
POTASSIUM PHOSPHATE, TRIBASIC
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70810-001	70810-001-01, 70810-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Hydrogen Peroxide	BBX060AN9V	ACTIB
CARBOXYPOLYMETHYLENE	0A5MM307FC	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POTASSIUM PHOSPHATE, TRIBASIC	16D59922JU	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT

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
680f8bfa-22a1-4650-bbd7-6bbde08388d6			5b0c140c-33bf-48b4-9f1e-10fa674c1ee6	2016-07-06	Warnings	Exact identifier spl id: 680f8bfa-22a1-4650-bbd7-6bbde08388d6 spl set id: 5b0c140c-33bf-48b4-9f1e-10fa674c1ee6

Reported adverse events (FAERS/openFDA)#

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