FDA Label for Pro Brighten Tooth Whitening Gel

View Indications, Usage & Precautions

Pro Brighten Tooth Whitening Gel Product Label

The following document was submitted to the FDA by the labeler of this product Sangleaf Pharm., Co Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Hydrogen Peroxide 3.00%


Otc - 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


Otc - 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


Otc - 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


* Please review the disclaimer below.