Lutooth Tooth Whitening Kit
FDA Label NDC 70635-0001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quorum Bio Co.,ltd for the product Lutooth Tooth Whitening Kit (NDC 70635-0001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications and usage, dosage and administration, package label. principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.