Active Ingredient
Phthalimidoperoxycaproic Acid(PAP)
Potassium Citrate
Hydroxyapatite
Teeth Whitening Kit Cream
FDA Label NDC 83778-002
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 Teeth Whitening Kit (NDC 83778-002). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Teeth whitening, anti-sensitivity, remineralization
Use
Teeth stains from coffee, tobacco, genetic, tetracycline, food coloring, aging and other factors that may cause discoloration.
Warnings
Don't swallow. Avoid applying gel on the gum and lips.
Do Not Use
1. Not suitable for ceramic or false teeth.
2. Not suitable for teeth discoloration caused by lesion or medicine.
3. Not suitable for severe tetracycline and decayed teeth.
4. Not suitable for defective enamel, exerted dentin and damaged teeth.
5. Not suitable for children under 16 years old
When Using
Don't swallow. Avoidapplying gel on the gum and lips.
Stop Use
Stop treatment when feel severe pain
Ask Doctor
Seek doctor's advice prior to use if pregnant, breast-feeding, having gum problem or had an oral operation recently
Keep Oot Of Reach Of Children
Keep out of reach of children.
Directions
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.
Other Information
Avoid sunlight and keep in dry & cool place
Inactive Ingredients
Glycerin、Aqua、Polyvinylpyrrolidone(PVP)、Ammonium
Acryloyldimethyltaurate/VP Copolymer、Potassium Hydroxide、Mentha Piperita (peppermint) oil 、Mica、Titanium Dioxide、Saccharin Sodium、Piroctone Olamine
Principal Display Panel
01 (Label)
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