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, 1.2%/5%, for topical useInitial U.S. Approval: 2000
Approved
Approval ID
83d52507-99a1-4461-b067-5ec01dc6c5d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
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 Code70710-1445
Application NumberANDA210794
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clindamycin Phosphate and Benzoyl Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (12)
CLINDAMYCIN PHOSPHATEActive
Quantity: 10 mg in 1 g
Code: EH6D7113I8
Classification: ACTIB
BENZOYL PEROXIDEActive
Quantity: 50 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
DISODIUM LAURYL SULFOSUCCINATEInactive
Code: P160Q81342
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLOXAMER 182Inactive
Code: JX0HIX6OAG
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT