TEETH WHITENING KIT- teeth whitening kit cream 
Nanchang Dental Bright Technology Co.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient

Phthalimidoperoxycaproic Acid(PAP)
Potassium Citrate
Hydroxyapatite

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

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

TEETH WHITENING KIT 
teeth whitening kit cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83778-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE1 g  in 100 mL
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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POVIDONE (UNII: FZ989GH94E)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MICA (UNII: V8A1AW0880)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83778-002-016 mL in 1 BOTTLE; Type 0: Not a Combination Product11/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/05/2023
Labeler - Nanchang Dental Bright Technology Co.,Ltd. (544503502)
Establishment
NameAddressID/FEIBusiness Operations
Nanchang Dental Bright Technology Co.,Ltd.544503502label(83778-002) , manufacture(83778-002)

Revised: 11/2023
Document Id: 0973b73d-5dea-0986-e063-6294a90a5917
Set id: 0973b73d-5de9-0986-e063-6294a90a5917
Version: 1
Effective Time: 20231105
 
Nanchang Dental Bright Technology Co.,Ltd.