1. Home
  2. Labeler Index
  3. Quorum Bio Co.,ltd
  4. 70635-0001
  5. Label Information: Lutooth Tooth Whitening Kit

FDA Label for Lutooth Tooth Whitening Kit

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. PURPOSE
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. INDICATIONS AND USAGE
    7. DOSAGE AND ADMINISTRATION
    8. PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Lutooth Tooth Whitening Kit Product Label

The following document was submitted to the FDA by the labeler of this product Quorum Bio Co.,ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.

  • 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 Cycle
  • Repeat (Three cycles a day)
  • 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 - Label

Label - Label


* Please review the disclaimer below.