Clindamycin Phosphate and Benzoyl Peroxide
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . , for topical use Initial U.S. Approval: 2000
Approved
Approval ID
ac7f5c47-a06a-495f-a914-13c930106c8d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8635
Application NumberANDA205397
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clindamycin Phosphate, Benzoyl Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 17, 2023
FDA Product Classification
INGREDIENTS (6)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
BENZOYL PEROXIDEActive
Quantity: 25 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
CLINDAMYCIN PHOSPHATEActive
Quantity: 10 mg in 1 g
Code: EH6D7113I8
Classification: ACTIM