TWYNEO
These highlights do not include all the information needed to use TWYNEO safely and effectively. See full prescribing information for TWYNEO. TWYNEO (tretinoin and benzoyl peroxide) cream, 0.1%/3%, for topical use. Initial U.S. Approval: 2021
Approved
Approval ID
27208dff-e376-4c18-b56e-0a260f685a39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2023
Manufacturers
FDA
Galderma Laboratories, L.P.
DUNS: 047350186
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tretinoin and benzoyl peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0299-5945
Application NumberNDA214902
Product Classification
M
Marketing Category
C73594
G
Generic Name
tretinoin and benzoyl peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 11, 2023
FDA Product Classification
INGREDIENTS (2)
TretinoinActive
Quantity: 1 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
Benzoyl PeroxideActive
Quantity: 30 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB