LUTOOTH TOOTH WHITENING KIT- carbamide peroxide gel, dentifrice 
Quorum Bio CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Carbamide Peroxide 15%

INACTIVE INGREDIENT

Water, etc.

PURPOSE

Tooth whitening

WARNINGS

Persons who CANNOT use Lutooth whitening kit.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children.

INDICATIONS AND USAGE

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.

  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

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Label

LUTOOTH TOOTH WHITENING KIT 
carbamide peroxide gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70635-0003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70635-0003-24 in 1 PACKAGE03/01/201603/01/2016
1NDC:70635-0003-12 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:70635-0003-42 in 1 PACKAGE01/01/2016
2NDC:70635-0003-32 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2016
Labeler - Quorum Bio CO.,LTD (695798936)
Registrant - Quorum Bio CO.,LTD (695798936)
Establishment
NameAddressID/FEIBusiness Operations
Quorum Bio CO.,LTD695798936manufacture(70635-0003)

Revised: 10/2020
Document Id: b19bd4a1-bfa4-67fe-e053-2a95a90a3980
Set id: 33c910b1-5fd0-6a8e-e054-00144ff8d46c
Version: 4
Effective Time: 20201014
 
Quorum Bio CO.,LTD