MedPath
FDA Product

clindamycin and benzoyl peroxide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

clindamycin and benzoyl peroxide

16714-984

Regulatory Information

16714-984

ANDA209252

C73584

June 28, 2019

USA

Clindamycin and Benzoyl Peroxide Topical Gel, 1%/5%

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

NorthStar RxLLC

830546433

Active Ingredients

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

CLINDAMYCIN PHOSPHATE

Quantity: 10 mg in 1 g

Code: EH6D7113I8

Class Code: ACTIB

BENZOYL PEROXIDE

Quantity: 50 mg in 1 g

Code: W9WZN9A0GM

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)

Code: 4Q93RCW27E

Class Code: IACT

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

Active Moieties

CLINDAMYCIN

Code: 3U02EL437C

BENZOYL PEROXIDE

Code: W9WZN9A0GM

© Copyright 2025. All Rights Reserved by MedPath