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

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

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

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, 20090 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 ImageLabel 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: 06/2021 A-S Medication Solutions

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