Clindamycin Phosphate and Benzoyl Peroxide
These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL. CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE gel, for topical useInitial U.S. Approval: 2000
Approved
Approval ID
1d53ec2b-d33d-4245-99f1-e41b30303660
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2023
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clindamycin Phosphate and Benzoyl Peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-133
Application NumberNDA050819
Product Classification
M
Marketing Category
C73605
G
Generic Name
Clindamycin Phosphate and Benzoyl Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (6)
Benzoyl PeroxideActive
Quantity: 37.5 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
Clindamycin PhosphateActive
Quantity: 10 mg in 1 g
Code: EH6D7113I8
Classification: ACTIM
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT