FDA.reportPublic FDA data

TeethWhitening Kit

Manufacturer
Jiangxi Dentalbright Technology Co., Ltd.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:47:02

Label at a glance#

ProductTeethWhitening Kit
Active ingredientPOTASSIUM CITRATE, PHTHALIMIDOPEROXYCAPROIC ACID, TRIBASIC CALCIUM PHOSPHATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Phthalimidoperoxycaproic Acid(PAP)
Potassium Citrate
Hydroxyapatite

OTC - PURPOSE SECTION

Teeth whitening, anti-sensitivity, remineralization

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop treatment when feel severe pain

OTC - ASK DOCTOR SECTION

Stop treatment when feel severe pain

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION


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 SECTION


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

WARNINGS SECTION


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

INDICATIONS & USAGE SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83778-012-0183778-012-01

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83778-012-01TeethWhitening Kit6 mL in 1 BOTTLECREAM62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83778-012TEETHWHITENING KIT CREAM [JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD.]2Current NDC, 1 package rows20241222_29393313-217a-dc3a-e063-6294a90addb1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83778-01283778-012-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM CITRATEEE90ONI6FFACTIB
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
PHTHALIMIDOPEROXYCAPROIC ACID5OEJ6FAL6CACTIB
PVPFZ989GH94EIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
MICAV8A1AW0880IACT
AQUA059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TeethWhitening KitTEETHWHITENING KITJiangxi Dentalbright Technology Co., Ltd.29393313-217a-dc3a-e063-6294a90addb12024-12-20WarningsExact identifier
ndc (package): 83778-012-01
ndc (product): 83778-012
ndc11 (package): 83778001201
spl id: 29ae5783-e7c6-a892-e063-6394a90a47e2
spl set id: 29393313-217a-dc3a-e063-6294a90addb1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.