IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%
IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%
Approved
Approval ID
87395273-37fb-7cef-e053-2991aa0a54c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 23, 2019
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.
IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72934-1126
Product Classification
G
Generic Name
IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 23, 2019
FDA Product Classification
INGREDIENTS (3)
TRETINOINActive
Quantity: 0.05 g in 100 g
Code: 5688UTC01R
Classification: ACTIB
LEVOCETIRIZINE DIHYDROCHLORIDEActive
Quantity: 1 g in 100 g
Code: SOD6A38AGA
Classification: ACTIB
IMIQUIMODActive
Quantity: 5 g in 100 g
Code: P1QW714R7M
Classification: ACTIB