TEETHWHITENING KIT- teethwhitening kit cream 
Jiangxi Dentalbright Technology Co., Ltd.

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Phthalimidoperoxycaproic Acid(PAP)
Potassium Citrate
Hydroxyapatite

Teeth whitening, anti-sensitivity, remineralization

Don't swallow. Avoidapplying gel on the gum and lips.

Stop treatment when feel severe pain

Stop treatment when feel severe pain

Keep out of reach of children.


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.


Glycerin􀀀Aqua􀀀Polyvinylpyrrolidone(PVP)􀀀Ammonium
Acryloyldimethyltaurate/VP Copolymer􀀀Potassium Hydroxide􀀀Mentha Piperita
(peppermint) oil 􀀀Mica􀀀Titanium Dioxide􀀀Saccharin Sodium􀀀Piroctone Olamine
PRINCIPAL DISPLAY


Don't swallow. Avoid applying gel on the gum and lips.Avoid sunlight and keep in dry & cool place

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.

83778-012-01

TEETHWHITENING KIT 
teethwhitening kit cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83778-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) POTASSIUM CITRATE3 g  in 100 mL
PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C) (PHTHALIMIDOPEROXYCAPROIC ACID - UNII:5OEJ6FAL6C) PHTHALIMIDOPEROXYCAPROIC ACID12 g  in 100 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
PVP (UNII: FZ989GH94E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
MICA (UNII: V8A1AW0880)  
AQUA (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83778-012-016 mL in 1 BOTTLE; Type 0: Not a Combination Product12/14/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02212/14/2024
Labeler - Jiangxi Dentalbright Technology Co., Ltd. (544503502)

Revised: 12/2024
Document Id: 29ae5783-e7c6-a892-e063-6394a90a47e2
Set id: 29393313-217a-dc3a-e063-6294a90addb1
Version: 2
Effective Time: 20241220
 
Jiangxi Dentalbright Technology Co., Ltd.