NDC 57557-100

Othree 50 Whitening

Titanium Dioxide, Zinc Oxide, Octinoxate, Octocrylene

Othree 50 Whitening is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Cellab Co., Ltd.. The primary component is Titanium Dioxide; Zinc Oxide; Octinoxate; Octocrylene.

Product ID57557-100_28af1500-9e59-4101-bc90-d6a7e4bb184e
NDC57557-100
Product TypeHuman Otc Drug
Proprietary NameOthree 50 Whitening
Generic NameTitanium Dioxide, Zinc Oxide, Octinoxate, Octocrylene
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-04-03
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameCellab Co., Ltd.
Substance NameTITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTOCRYLENE
Active Ingredient Strength4 g/80g; g/80g; g/80g; g/80g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57557-100-02

1 TUBE in 1 CARTON (57557-100-02) > 80 g in 1 TUBE (57557-100-01)
Marketing Start Date2013-04-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57557-100-01 [57557010001]

Othree 50 Whitening CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-04-03

NDC 57557-100-02 [57557010002]

Othree 50 Whitening CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-04-03
Inactivation Date2020-01-31
Reactivation Date2020-03-25

Drug Details

Active Ingredients

IngredientStrength
TITANIUM DIOXIDE3.936 g/80g

OpenFDA Data

SPL SET ID:7c287ad5-b572-444d-a67f-62b9bcdf1c1a
Manufacturer
UNII
UPC Code
  • 8802070700314

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