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Lutooth Tooth Whitening Kit by Dent-White Co LTD

Dosage form: gel, dentifrice
Ingredients: CARBAMIDE PEROXIDE 8.3g in 100mL
Labeler: Dent-White Co LTD
NDC Code: 70635-0001

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.

ACTIVE INGREDIENT

Carbamide Peroxide 8.3%

INACTIVE INGREDIENT

Water, etc.

PURPOSE

Tooth whitening

WARNINGS

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

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
  • 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

LUTOOTH TOOTH WHITENING KIT 
carbamide peroxide gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70635-0001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE8.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:70635-0001-24 APPLICATOR in 1 PACKAGE
1NDC:70635-0001-12 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2016
Labeler - Dent-White Co LTD (689847038)
Registrant - Dent-White Co LTD (689847038)
Establishment
NameAddressID/FEIOperations
Dent-White Co LTD689847038manufacture(70635-0001)

Revised: 06/2016
 
Dent-White Co LTD

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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