TEETHWHITENING KIT cream

TeethWhitening Kit by

Drug Labeling and Warnings

TeethWhitening Kit by is a Otc medication manufactured, distributed, or labeled by Jiangxi Dentalbright Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Phthalimidoperoxycaproic Acid(PAP)
Potassium Citrate
Hydroxyapatite

PURPOSE

Teeth whitening, anti-sensitivity, remineralization

WHEN USING

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

STOP USE

Stop treatment when feel severe pain

ASK DOCTOR

Stop treatment when feel severe pain

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEETHWHITENING KIT 
teethwhitening kit cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83778-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	POTASSIUM CITRATE	3 g  in 100 mL
PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C) (PHTHALIMIDOPEROXYCAPROIC ACID - UNII:5OEJ6FAL6C)	PHTHALIMIDOPEROXYCAPROIC ACID	12 g  in 100 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83778-012-01	6 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	12/14/2024

Labeler - Jiangxi Dentalbright Technology Co., Ltd. (544503502)