FDA.reportPublic FDA data

Lutooth Tooth Whitening Kit

Manufacturer
Quorum Bio CO.,LTD
Effective date
2020-10-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:31:37

Label at a glance#

ProductLutooth Tooth Whitening Kit
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Indications and uses

Tooth Whitening Procedure & Method You can find video clips of 'How to Use' at Lutooth hompage (http://www.lutooth.com) For detailed descriptions, plase refer to the user manual inside the product package . Exercise of installation The Use of Whitening Stick Put Cotton rolls Put the lip&cheek retractor Wipe saliva with the cotton roll Apply whitening gels Installation & Operation of LED Accelerator Finishing 1 Cyc...

Dosage and administration

If you want rapid effects, repeat 12 cycles (it takes one hour) or until desired whitening results are achieved. For the best effect, it is preferable to carry out every day for 4 days. Then, repeat the whitening cycle again for 4 days after 2 or 3 days break.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 15%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Water, etc.

PURPOSE

OTC - PURPOSE SECTION

Tooth whitening

WARNINGS

WARNINGS SECTION

Persons who CANNOT use Lutooth whitening kit.

  • To be on the safe side, pregnant and breastfeeding women, children under the age of 14 should postpone tooth whitening.
  • DO NOT use if teeth or gum are not healthy.
  • Avoid ingestion and contact with eyes and skin. If contact occurs, wipe gel off and rinse with water.
  • The LED device should not be used for other purpose.
  • If sensitivity or gum irritation occurs, please stop using whitening gel and consult your dentist.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of babies and children.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Tooth Whitening Procedure & Method

You can find video clips of 'How to Use' at Lutooth hompage (www.lutooth.com)

For detailed descriptions, plase refer to the user manual inside the product package.

  1. Exercise of installation
  2. The Use of Whitening Stick
  3. Put Cotton rolls
  4. Put the lip&cheek retractor
  5. Wipe saliva with the cotton roll
  6. Apply whitening gels
  7. Installation & Operation of LED Accelerator
  8. Finishing 1 Cycle
  9. Repeat (Three cycles a day)
  10. Turn on LED light without whitening gels (Optional)

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

  • If you want rapid effects, repeat 12 cycles (it takes one hour) or until desired whitening results are achieved.
  • For the best effect, it is preferable to carry out every day for 4 days.
  • Then, repeat the whitening cycle again for 4 days after 2 or 3 days break.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1653115carbamide peroxide 15 % Oral GelPSN4
1653115carbamide peroxide 0.15 MG/MG Oral GelSCD4
1653115carbamide peroxide 15 % Dental GelSY4
1653115carbamide peroxide 15 % Oral GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70635-0003-22022-01-28C16284748780-1ab0e2407-28ba-f274-e053-dbdaa90a647133c910b1-5fd0-6a8e-e054-00144ff8d46c
70635-0003-42022-01-28C16284748780-1ab0e2407-28ba-f274-e053-dbdaa90a647133c910b1-5fd0-6a8e-e054-00144ff8d46c
70635-0003-22020-07-22C16284748780-1ab0e2407-28ba-f274-e053-dbdaa90a647133c910b1-5fd0-6a8e-e054-00144ff8d46c
70635-0003-42020-07-22C16284748780-1ab0e2407-28ba-f274-e053-dbdaa90a647133c910b1-5fd0-6a8e-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70635-0003-1Lutooth Tooth Whitening Kit2 mL in 1 APPLICATORGEL, DENTIFRICE24
70635-0003-2Lutooth Tooth Whitening Kit4 in 1 PACKAGEGEL, DENTIFRICE44
70635-0003-3Lutooth Tooth Whitening Kit2 mL in 1 APPLICATORGEL, DENTIFRICE24
70635-0003-4Lutooth Tooth Whitening Kit2 in 1 PACKAGEGEL, DENTIFRICE24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70635-0003LUTOOTH TOOTH WHITENING KIT (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [QUORUM BIO CO.,LTD]4Legacy NDC, 4 package rows20201015_33c910b1-5fd0-6a8e-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70635-000370635-0003-1, 70635-0003-2, 70635-0003-3, 70635-0003-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

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
b19bd4a1-bfa4-67fe-e053-2a95a90a398033c910b1-5fd0-6a8e-e054-00144ff8d46c2020-10-14WarningsExact identifier
spl id: b19bd4a1-bfa4-67fe-e053-2a95a90a3980
spl set id: 33c910b1-5fd0-6a8e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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