FINACEA FOAM (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

FINACEA (azelaic acid) Foam 15% is a white to off-white emulsion supplied in a pressurized 50 g (NDC 50222-303-50) aluminum can.

Storage and Handling

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

Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).

17 PATIENT COUNSELING INFORMATION

Inform patients using FINACEA Foam of the following:

Administration Instructions

• For topical use only.
• Shake well before use.
• Before applying FINACEA Foam, 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 Foam.
• Cosmetics may be applied after the application of FINACEA Foam has dried.
• Avoid the use of occlusive dressings and wrappings.
• Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
• If allergic reactions occur, discontinue use and consult your physician.
• Discard product 8 weeks after opening [see Dosage and Administration (2)].

Hypopigmentation

• Advise patients to report abnormal changes in skin color to their healthcare provider [see Warnings and Precautions (5.1)].

Eye and Mucous Membranes Irritation

• Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult your physician if eye irritation persists [see Warnings and Precautions (5.2)].

Flammability

• The propellant in FINACEA Foam is flammable. Avoid fire, flame, or smoking during and immediately following application [see Warnings and Precautions (5.3)].

FINACEA is a registered trademark of LEO Pharma A/S.
© 2020, LEO Pharma Inc. All rights reserved.

Manufactured for:

LEO Pharma Inc., Seven Giralda Farms, Madison, NJ 07940 USA

Manufactured by:

ASM Aerosol-Service AG, Industriestrasse 11, 4313 Moehlin, Switzerland

PRINCIPAL DISPLAY PANEL — 50 g Can Carton

NDC 50222-303-50

Finacea^®
(azelaic acid)
Foam, 15%

For Topical Use Only

Not for ophthalmic,
oral or intravaginal use

Rx only

Net Wt. 50 g

LEO^®

PRINCIPAL DISPLAY PANEL — 15 g Can Carton

NDC 50222-303-91

Finacea^®
(azelaic acid)
Foam, 15%

For Topical Use Only

Not for ophthalmic,
oral or intravaginal
use

Sample — Not For Sale

Rx only

Net Wt. 15 g

LEO^®

FINACEA FOAM azelaic acid aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50222-303 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELAIC ACID (AZELAIC ACID) AZELAIC ACID .15 g in 1 g

Inactive Ingredients Ingredient Name Strength BENZOIC ACID CETOSTEARYL ALCOHOL DIMETHYL ISOSORBIDE GLYCERYL MONO AND DIPALMITOSTEARATE MEDIUM-CHAIN TRIGLYCERIDES METHYLCELLULOSE (4000 MPA.S) POLYOXYL 40 STEARATE POLYSORBATE 80 PROPYLENE GLYCOL SODIUM HYDROXIDE WATER XANTHAN GUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50222-303-50 1 CAN in 1 CARTON contains a CAN 1 50 g in 1 CAN This package is contained within the CARTON (50222-303-50) 2 NDC:50222-303-91 1 CAN in 1 CARTON contains a CAN 2 15 g in 1 CAN This package is contained within the CARTON (50222-303-91)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA207071 10/01/2018

Labeler — LEO Pharma Inc. (832692615)

Establishment
Name	Address	ID/FEI	Operations
ASM Aerosol-Service AG		480286111	MANUFACTURE (50222-303)

Revised: 12/2020 LEO Pharma Inc.