Otc - Active Ingredient
Hydrogen Peroxide 3.00%
Pro Brighten Tooth Whitening Gel
FDA Label NDC 70810-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sangleaf Pharm., Co Ltd for the product Pro Brighten Tooth Whitening Gel (NDC 70810-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - ask doctor, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
