Neuac
These highlights do not include all the information needed to use Neuac (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% safely and effectively. See full prescribing information for Neuac (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5%. Neuac (CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE) gel, for topical use. Initial U.S. Approval: 2000
Approved
Approval ID
e2cd1c2a-00ee-465e-a4f4-9c0a0bc6266f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Medimetriks Pharmaceuticals
DUNS: 019903816
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 Code43538-176
Application NumberANDA090979
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin phosphate and benzoyl peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (9)
clindamycin phosphateActive
Quantity: 10 mg in 1 g
Code: EH6D7113I8
Classification: ACTIM
benzoyl peroxideActive
Quantity: 50 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
dimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT