Clindamycin Phosphate and Benzoyl Peroxide
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL
Approved
Approval ID
cc45f9bc-4639-4d95-b12d-01f6504592bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1450
Application NumberANDA210794
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clindamycin Phosphate and Benzoyl Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 4, 2022
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLOXAMER 182Inactive
Code: JX0HIX6OAG
Classification: IACT
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
DISODIUM LAURYL SULFOSUCCINATEInactive
Code: P160Q81342
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT