NDC | 70635-0003-1, 70635-0003-2, 70635-0003-3, 70635-0003-4 |
Set ID | 33c910b1-5fd0-6a8e-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Quorum Bio CO.,LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
-
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
-
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
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LUTOOTH TOOTH WHITENING KIT
carbamide peroxide gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70635-0003 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 15 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70635-0003-2 4 in 1 PACKAGE 03/01/2016 03/01/2016 1 NDC:70635-0003-1 2 mL in 1 APPLICATOR; Type 0: Not a Combination Product 2 NDC:70635-0003-4 2 in 1 PACKAGE 01/01/2016 2 NDC:70635-0003-3 2 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/01/2016 Labeler - Quorum Bio CO.,LTD (695798936) Registrant - Quorum Bio CO.,LTD (695798936) Establishment Name Address ID/FEI Business Operations Quorum Bio CO.,LTD 695798936 manufacture(70635-0003)