Drugplain

ADAPALENE AND BENZOYL PEROXIDE 3 mg/g

adapalene and benzoyl peroxide · GEL · Bryant Ranch Prepack

1 Recall on Record
Plain English

ADAPALENE AND BENZOYL PEROXIDE is a gel containing adapalene and benzoyl peroxide at 3 mg/g, taken topical. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
ADAPALENE AND BENZOYL PEROXIDE
Generic Name
adapalene and benzoyl peroxide
NDC Code (Product)
63629-9322
Manufacturer
Bryant Ranch Prepack
Strength
3 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
ANDA212464
Drug Class
Retinoid [EPC]
Marketing Start
06/02/2022

Recall History

1 Recall on Record
Class II02/12/2024

MCKESSON CORPORATION

CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective10 reports
rash8 reports
acne5 reports
application site pain4 reports
erythema4 reports
application site erythema3 reports
application site pruritus3 reports
burning sensation3 reports
skin burning sensation3 reports
application site irritation2 reports

Frequently Asked Questions

What is ADAPALENE AND BENZOYL PEROXIDE used for?

ADAPALENE AND BENZOYL PEROXIDE contains adapalene and benzoyl peroxide. It is a gel taken topical. Consult your doctor for specific uses.

Is ADAPALENE AND BENZOYL PEROXIDE a controlled substance?

ADAPALENE AND BENZOYL PEROXIDE is not classified as a controlled substance by the DEA.

What is the generic name for ADAPALENE AND BENZOYL PEROXIDE?

The generic name for ADAPALENE AND BENZOYL PEROXIDE is adapalene and benzoyl peroxide. There are 10 other brand versions of adapalene and benzoyl peroxide.

What is the NDC code for ADAPALENE AND BENZOYL PEROXIDE 3 mg/g?

The NDC (National Drug Code) for ADAPALENE AND BENZOYL PEROXIDE 3 mg/g is 63629-9322, listed by Bryant Ranch Prepack.