NDC 70635-0001

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 ID70635-0001_80bc5faf-aeb7-e8e5-e053-2a91aa0a9e85
NDC70635-0001
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 Strength8 g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70635-0001-3

2 APPLICATOR in 1 PACKAGE (70635-0001-3) > 2 mL in 1 APPLICATOR (70635-0001-1)
Marketing Start Date2016-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70635-0001-1 [70635000101]

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

NDC 70635-0001-2 [70635000102]

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

Drug Details

Active Ingredients

IngredientStrength
CARBAMIDE PEROXIDE8.3 g/100mL

OpenFDA Data

SPL SET ID:319704ba-5c42-4858-e054-00144ff88e88
Manufacturer
UNII

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

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