Cabtreo
These highlights do not include all the information needed to use CABTREO safely and effectively. See full prescribing information for CABTREO. CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel Initial U.S. Approval: 2023
Approved
Approval ID
9468da0f-9978-4c58-8135-0274c3415084
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Bausch Health US LLC
DUNS: 831922468
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clindamycin phosphate/benzoyl peroxide/adapalene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0187-0006
Application NumberNDA216632
Product Classification
M
Marketing Category
C73594
G
Generic Name
clindamycin phosphate/benzoyl peroxide/adapalene
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (7)
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
CLINDAMYCIN PHOSPHATEActive
Quantity: 12 mg in 1 g
Code: EH6D7113I8
Classification: ACTIM
BENZOYL PEROXIDEActive
Quantity: 31 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
ADAPALENEActive
Quantity: 1.5 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB