Label: LUTOOTH TOOTH WHITENING KIT- carbamide peroxide gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated October 14, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Carbamide Peroxide 15%

  • 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

    Label

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!