PRO BRIGHTEN TOOTH WHITENING GEL- hydrogen peroxide gel

Pro Brighten Tooth whitening Gel by

Drug Labeling and Warnings

Pro Brighten Tooth whitening Gel by is a Otc medication manufactured, distributed, or labeled by Sangleaf Pharm., Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrogen Peroxide 3.00%

PURPOSE

Oral Debriding

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

For external use only

ASK DOCTOR

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

KEEP OUT OF REACH OF CHILDREN

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRO BRIGHTEN TOOTH WHITENING GEL 
hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70810-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrogen Peroxide (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	Hydrogen Peroxide	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM PHOSPHATE, TRIBASIC (UNII: 16D59922JU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70810-001-02	1 in 1 CARTON	07/06/2016
1	NDC: 70810-001-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/06/2016

Labeler - Sangleaf Pharm., Co Ltd (689847343)

Registrant - Sangleaf Pharm., Co Ltd (689847343)

Establishment
Name	Address	ID/FEI	Business Operations
Sangleaf Pharm., Co Ltd		689847343	manufacture(70810-001)