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 use Initial U.S. Approval: 2000
Approved
Approval ID
edae294f-cc8b-4f94-8d90-4c764fda307b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2020
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 Code68682-132
Application NumberNDA050819
Product Classification
M
Marketing Category
C73605
G
Generic Name
Clindamycin Phosphate and Benzoyl Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2020
FDA Product Classification
INGREDIENTS (6)
Benzoyl PeroxideActive
Quantity: 25 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
Clindamycin PhosphateActive
Quantity: 10 mg in 1 g
Code: EH6D7113I8
Classification: ACTIM
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT