Otc - Active Ingredient
Phthalimidoperoxycaproic Acid(PAP)
Potassium Citrate
Hydroxyapatite
Teethwhitening Kit Cream
FDA Label NDC 83778-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Dentalbright Technology Co., Ltd. for the product Teethwhitening Kit (NDC 83778-012). 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, otc - when using, otc - stop use, otc - ask doctor, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Teeth whitening, anti-sensitivity, remineralization
Otc - When Using
Don't swallow. Avoidapplying gel on the gum and lips.
Otc - Stop Use
Stop treatment when feel severe pain
Otc - Ask Doctor
Stop treatment when feel severe pain
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
1. Dry your teeth and rinse mouthpiece before use.
2. Looking in the mirror to record which stage you are with shade guide paper.
3. Twist whitening pen until the gel flows. apply the gel evenly on both upper and lower
teeth. Each time use about 0.5-0.7ml.
4. Put mouthpiece into your mouth and bite it, then press power button for 1.5 seconds
to start the treatment. (Tips: start with blue color, press again to turn red within 5
seconds; double press to turn red and blue within 5 seconds.)
5. The led light will turn off automatically after 16 minutes, rinse the mouthpiece and
mouth with water and compare your teeth with shade guide paper again to see how
many stages you have improved.
6. Don't eat or drink anything except water in 30 minutes after treatment.
Inactive Ingredient
Glycerin����Aqua����Polyvinylpyrrolidone(PVP)����Ammonium
Acryloyldimethyltaurate/VP Copolymer����Potassium Hydroxide����Mentha Piperita
(peppermint) oil ����Mica����Titanium Dioxide����Saccharin Sodium����Piroctone Olamine
PRINCIPAL DISPLAY
Warnings
Don't swallow. Avoid applying gel on the gum and lips.Avoid sunlight and keep in dry & cool place
Indications & Usage
1. Dry your teeth and rinse mouthpiece before use
2. Looking in the mirror to recor which stage you are with shadeyuide paper.
3. Twist whitening pen until the gel flows. apply the gel evenly on bath upper and lower..teeth. Each time use about 0.5-0.7ml
4. Put mouthpiece into your mouth and bite it, then press power bltton for 1.5 secondst with blue color, press again to turn red within 5 to start the treatment.(Tips: stad and blue within 5 seconds.)seconds; double press to turn re
5. The led light will turn off automatically after 16 minutes, rinse themouthpiece andmouth with water and compareour teeth with shade guide paperagain to see howmany stages you have improved
6. Don't eat or drink anything exept water in 30 minutes after treatment.
* Please review the disclaimer below.
