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141061 HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.025%

141061 HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.025%

Approved
Approval ID

a97b05f1-b004-93e6-e053-2a95a90ab95d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 2, 2020

Manufacturers
FDA

Sincerus Florida, LLC

DUNS: 080105003

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

141061 HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.025%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72934-6233
Product Classification
G
Generic Name
141061 HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.025%
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 2, 2020
FDA Product Classification

INGREDIENTS (3)

HYDROQUINONEActive
Quantity: 8 g in 100 g
Code: XV74C1N1AE
Classification: ACTIB
HYDROCORTISONEActive
Quantity: 0.5 g in 100 g
Code: WI4X0X7BPJ
Classification: ACTIB
TRETINOINActive
Quantity: 0.025 g in 100 g
Code: 5688UTC01R
Classification: ACTIB

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141061 HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.025% - FDA Drug Approval Details