Finacea (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-4473

NDC: 50090-4473-0 50 g in a TUBE / 1 in a CARTON

17 PATIENT COUNSELING INFORMATION

Inform patients using FINACEA Gel of the following:

Administration Instructions

• For topical use only.
• Before applying FINACEA Gel, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel.
• Wash hands immediately following application of FINACEA Gel.
• Cosmetics may be applied after the application of FINACEA Gel has dried.
• Avoid the use of occlusive dressings or wrappings.
• Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents [see Dosage and Administration (2)].

Hypersensitivity

• If allergic reactions occur, discontinue use and consult their healthcare provider [see Warnings and Precautions (5.1)].

Skin Irritation

• Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA Gel, usually during the first few weeks of treatment. If irritation is excessive or persists, or allergic reactions occur, discontinue use and consult your physician [see Warnings and Precautions (5.2)].

Hypopigmentation

• Advise patients to report abnormal changes in skin color to their healthcare provider [see Warnings and Precautions (5.2)].

Eye and Mucous Membranes Irritation

• Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel comes in contact with the eyes, wash the eyes with large amounts of water and consult their healthcare provider if eye irritation persists [see Warnings and Precautions (5.3)].

Exacerbation of Asthma

• Advise patients to report any worsening of asthma to their healthcare provider [see Warnings and Precautions (5.4)].

FINACEA is a registered trademark of LEO Pharma A/S.© 2021, LEO Pharma Inc. All rights reserved.

Manufactured for:

LEO Pharma Inc., Madison, NJ 07940 USA

Manufactured by:

LEO Pharma Manufacturing Italy S.r.l., Via E Schering 21, 20054 Segrate, Milano, Italy

Storage

Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].

azelaic acid

Label Image

FINACEA azelaic acid gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4473(NDC:50222-505) Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELAIC ACID (AZELAIC ACID) AZELAIC ACID 0.15 g in 1 g

Inactive Ingredients Ingredient Name Strength BENZOIC ACID EDETATE DISODIUM 1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINE MEDIUM-CHAIN TRIGLYCERIDES POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 PROPYLENE GLYCOL SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50090-4473-0 1 TUBE in 1 CARTON contains a TUBE 1 50 g in 1 TUBE This package is contained within the CARTON (50090-4473-0)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021470 12/24/2002

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-4473)

Revised: 02/2023 A-S Medication Solutions