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HYDROQUINONE 4%

HYDROQUINONE 4% CREAM

Approved
Approval ID

595dfc50-ee6f-41b5-ab5b-4c293aee342b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 15, 2024

Manufacturers
FDA

Acella Pharmaceuticals, LLC

DUNS: 825380939

Products 1

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

Hydroquinone

PRODUCT DETAILS

NDC Product Code42192-151
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateSeptember 11, 2018
Generic NameHydroquinone

INGREDIENTS (15)

KOJIC ACIDInactive
Code: 6K23F1TT52
Classification: IACT
C13-14 ISOPARAFFINInactive
Code: E4F12ROE70
Classification: IACT
CAPRYLOYL GLYCINEInactive
Code: 8TY5YO42NJ
Classification: IACT
LAURETH-7Inactive
Code: Z95S6G8201
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)Inactive
Code: RHA9LWJ494
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROQUINONEActive
Quantity: 40 mg in 1 g
Code: XV74C1N1AE
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCOLIC ACIDInactive
Code: 0WT12SX38S
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

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HYDROQUINONE 4% - FDA Drug Approval Details