NDC 68343-001

Dermisa Skin Fade

Hydroquinone Padimate O

Dermisa Skin Fade is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Montani Cosmetics Inc. The primary component is Hydroquinone; Padimate O.

Product ID68343-001_71653743-e77e-90b0-e053-2995a90a1e98
NDC68343-001
Product TypeHuman Otc Drug
Proprietary NameDermisa Skin Fade
Generic NameHydroquinone Padimate O
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2011-09-15
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart358A
Labeler NameMontani Cosmetics Inc
Substance NameHYDROQUINONE; PADIMATE O
Active Ingredient Strength2 g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68343-001-01

1 TUBE in 1 BOX (68343-001-01) > 50 g in 1 TUBE (68343-001-50)
Marketing Start Date2011-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68343-001-25 [68343000125]

Dermisa Skin Fade CREAM
Marketing CategoryOTC monograph not final
Application Numberpart358A
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-05-21

NDC 68343-001-50 [68343000150]

Dermisa Skin Fade CREAM
Marketing CategoryOTC monograph not final
Application Numberpart358A
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-09-15

NDC 68343-001-02 [68343000102]

Dermisa Skin Fade CREAM
Marketing CategoryOTC monograph not final
Application Numberpart358A
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-09-15

NDC 68343-001-01 [68343000101]

Dermisa Skin Fade CREAM
Marketing CategoryOTC monograph not final
Application Numberpart358A
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-09-15

Drug Details

Active Ingredients

IngredientStrength
HYDROQUINONE2 g/100g

OpenFDA Data

SPL SET ID:03fff226-a013-4a71-926e-5df3661be22e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 153031
    • UPC Code
  • 0766989000010

    • Trademark Results [Dermisa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DERMISA
    DERMISA
    85121683 3954750 Live/Registered
    Montani Cosmetics, Inc.
    2010-09-02
    DERMISA
    DERMISA
    75678601 2395126 Dead/Cancelled
    MONTANI COSMETICS, INC.
    1999-04-09
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