NDC 70635-0003

Lutooth Tooth Whitening Kit

Carbamide Peroxide

Lutooth Tooth Whitening Kit is a Dental Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Quorum Bio Co.,ltd. The primary component is Carbamide Peroxide.

Product ID70635-0003_80bc5faf-aead-e8e5-e053-2a91aa0a9e85
NDC70635-0003
Product TypeHuman Otc Drug
Proprietary NameLutooth Tooth Whitening Kit
Generic NameCarbamide Peroxide
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2016-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameQuorum Bio CO.,LTD
Substance NameCARBAMIDE PEROXIDE
Active Ingredient Strength15 g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70635-0003-4

2 APPLICATOR in 1 PACKAGE (70635-0003-4) > 2 mL in 1 APPLICATOR (70635-0003-3)
Marketing Start Date2016-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70635-0003-2 [70635000302]

Lutooth Tooth Whitening Kit GEL, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-03-01
Marketing End Date2016-03-01

NDC 70635-0003-1 [70635000301]

Lutooth Tooth Whitening Kit GEL, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-01-01

NDC 70635-0003-4 [70635000304]

Lutooth Tooth Whitening Kit GEL, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-01-01

NDC 70635-0003-3 [70635000303]

Lutooth Tooth Whitening Kit GEL, DENTIFRICE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-09

Drug Details

Active Ingredients

IngredientStrength
CARBAMIDE PEROXIDE15 g/100mL

OpenFDA Data

SPL SET ID:33c910b1-5fd0-6a8e-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1653115

    • NDC Crossover Matching brand name "Lutooth Tooth Whitening Kit" or generic name "Carbamide Peroxide"

    NDCBrand NameGeneric Name
    70635-0001Lutooth Tooth Whitening KitLutooth Tooth Whitening Kit
    70635-0003Lutooth Tooth Whitening KitLutooth Tooth Whitening Kit
    53145-311AuralytCarbamide Peroxide
    13709-230ClearCanal Ear Wax Softerner DropsCarbamide Peroxide
    0295-1231DEBROXCarbamide Peroxide
    50090-4201DEBROXCarbamide Peroxide
    53943-838Discount Drug Mart Earwax Removal DropsCARBAMIDE PEROXIDE
    53943-835DISCOUNT drug mart FOOD FAIR earwax removal kitCARBAMIDE PEROXIDE
    47649-9001Dr. Whitiss (8.3%)CARBAMIDE PEROXIDE
    47649-0101Dr.Whitiss 10%CARBAMIDE PEROXIDE
    47649-1101Dr.Whitiss 15%CARBAMIDE PEROXIDE
    47649-1201Dr.Whitiss 20%CARBAMIDE PEROXIDE
    47649-1301Dr.Whitiss 35%CARBAMIDE PEROXIDE
    24385-955Ear DropsCarbamide Peroxide
    49794-003Ear Wax Removal AidCarbamide Peroxide
    11673-793Ear Wax Removal Aid DropsCarbamide peroxide
    21130-793Ear Wax Removal Aid DropsCarbamide peroxide
    0536-3000Ear Wax TreatmentCarbamide Peroxide
    21695-334Ear Wax TreatmentCarbamide Peroxide
    41250-835Earwax Removal KitCARBAMIDE PEROXIDE
    41163-835Equaline Earwax Removal DropsCARBAMIDE PEROXIDE
    55319-835Family Wellness Earwax Removal Earwax and BulbCARBAMIDE PEROXIDE
    0295-1226Gly-OxideCarbamide Peroxide
    24385-503Good Neighbor Pharmacy Ear SystemCarbamide Peroxide
    46122-556Good Neighbor Pharmacy Earwax RemovalCARBAMIDE PEROXIDE
    46122-557Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDE
    41250-282Meijer Earwax Removal DropsCARBAMIDE PEROXIDE
    0295-7362Murine EarCarbamide peroxide
    50090-3895Murine EarCarbamide peroxide
    13709-314NeilMed Clear Canal Earwax Removal kitCarbamide peroxide
    15579-838Otix Ear wax Removal DropsCARBAMIDE PEROXIDE
    15579-839Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDE
    55910-835Rexall Earwax RemovalCARBAMIDE PEROXIDE
    36800-835TopCare Earwax Removal KitCARBAMIDE PEROXIDE
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.