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FDA Drug information

Adapalene and benzoyl peroxide

Read time: 1 mins
Marketing start date: 30 Apr 2024
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Summary of product characteristics


Effective Time

20220606

Version

1

Spl Product Data Elements

Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide ADAPALENE ADAPALENE BENZOYL PEROXIDE BENZOYL PEROXIDE DOCUSATE SODIUM EDETATE DISODIUM GLYCERIN ISOHEXADECANE POLOXAMER 124 POLYSORBATE 80 PROPYLENE GLYCOL SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) SORBITAN MONOOLEATE WATER white to very pale yellow

Application Number

ANDA214553

Brand Name

Adapalene and benzoyl peroxide

Generic Name

Adapalene and benzoyl peroxide

Product Ndc

70771-1716

Product Type

HUMAN PRESCRIPTION DRUG

Route

TOPICAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Adapalene and benzoyl peroxide gel 0.3%/2.5% NDC 70771-1716-4 45 g Rx only container label carton label

Drug section

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