BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.05%
BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.05%
Approved
Approval ID
87ed3aff-1a1e-c070-e053-2a95a90af490
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 2, 2019
Manufacturers
FDA
Sincerus Florida LLC
DUNS: 080105003
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.05%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72934-1016
Product Classification
G
Generic Name
BENZOYL PEROXIDE 5% / CLINDAMYCIN 1% / NIACINAMIDE 2% / SPIRONOLACTONE 2% / TRETINOIN 0.05%
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 2, 2019
FDA Product Classification
INGREDIENTS (5)
CLINDAMYCIN PHOSPHATEActive
Quantity: 1 g in 100 g
Code: EH6D7113I8
Classification: ACTIB
BENZOYL PEROXIDEActive
Quantity: 5 g in 100 g
Code: W9WZN9A0GM
Classification: ACTIB
SPIRONOLACTONEActive
Quantity: 2 g in 100 g
Code: 27O7W4T232
Classification: ACTIB
NIACINAMIDEActive
Quantity: 2 g in 100 g
Code: 25X51I8RD4
Classification: ACTIB
TRETINOINActive
Quantity: 0.05 g in 100 g
Code: 5688UTC01R
Classification: ACTIB