adapalene and benzoyl peroxide

Basic Information

Product Name

FDA Product Code

72162-1430

Regulatory Information

NDC Product Code

72162-1430

Application Number

ANDA205033

Marketing Category

C73584

Effective Date

March 13, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ADAPALENE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for ADAPALENE and BENZOYL PEROXIDE GEL. ADAPALENE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2008

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

100

Active Ingredients

ADAPALENE

Quantity: 0.1 g in 100 g

Code: 1L4806J2QF

Class Code: ACTIB

BENZOYL PEROXIDE

Quantity: 2.5 g in 100 g

Code: W9WZN9A0GM

Class Code: ACTIB

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

ISOHEXADECANE

Code: 918X1OUF1E

Class Code: IACT

SORBITAN MONOOLEATE

Code: 06XEA2VD56

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

POLOXAMER 124

Code: 1S66E28KXA

Class Code: IACT

Active Moieties

BENZOYL PEROXIDE

Code: W9WZN9A0GM

ADAPALENE

Code: 1L4806J2QF

Basic Information

Regulatory Information

Company Information

Active Ingredients

DOCUSATE SODIUM

EDETATE DISODIUM

ISOHEXADECANE

SORBITAN MONOOLEATE

GLYCERIN

POLYSORBATE 80

PROPYLENE GLYCOL

WATER

POLOXAMER 124

Active Moieties

BENZOYL PEROXIDE

ADAPALENE