Teeth Whitening 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 01:31:06

Label at a glance#

ProductTeeth Whitening Kit
Active ingredientTRIBASIC CALCIUM PHOSPHATE, PHTHALIMIDOPEROXYCAPROIC ACID, POTASSIUM CITRATE
Label structure13 sections

Dosage and 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...

Storage and handling

Avoid sunlight and keep in dry & cool place

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Phthalimidoperoxycaproic Acid(PAP)
Potassium Citrate
Hydroxyapatite

Purpose

OTC - PURPOSE SECTION

Teeth whitening, anti-sensitivity, remineralization

Use

INDICATIONS & USAGE SECTION

Teeth stains from coffee, tobacco, genetic, tetracycline, food coloring, aging and other factors that may cause discoloration.

Warnings

WARNINGS SECTION

Don't swallow. Avoid applying gel on the gum and lips.

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

Stop Use

OTC - STOP USE SECTION

Stop treatment when feel severe pain

Ask Doctor

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

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.

Other information

STORAGE AND HANDLING SECTION

Avoid sunlight and keep in dry & cool place

Inactive ingredients

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 PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83778-002-012026-01-03C16284748780-12cef2736-a6a7-d83d-e063-dadaa90ab31f83778-002 Update
83778-002-012025-01-30C16284748780-12cef2736-a6a7-d83d-e063-dadaa90ab31f83778-002 Update

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83778-002-01Teeth Whitening Kit6 mL in 1 BOTTLECREAM62

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
83778-00283778-002-01

Ingredients#

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

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

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
Teeth Whitening KitTEETH WHITENING KITJiangxi Dentalbright Technology Co., Ltd0973b73d-5de9-0986-e063-6294a90a59172024-12-20WarningsExact identifier
ndc (package): 83778-002-01
ndc (product): 83778-002
ndc11 (package): 83778000201
spl id: 29c01cdf-48e8-77a6-e063-6294a90af25c
spl set id: 0973b73d-5de9-0986-e063-6294a90a5917

Reported adverse events (FAERS/openFDA)#

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