Finacea (Page 3 of 3)
16 HOW SUPPLIED/STORAGE AND HANDLING
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:
- 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)].
- If allergic reactions occur, discontinue use and consult their healthcare provider [see Warnings and Precautions (5.1)].
- 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)].
- 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.
LEO Pharma Inc., Madison, NJ 07940 USA
LEO Pharma Manufacturing Italy S.r.l., Via E Schering 21, 20054 Segrate, Milano, Italy
Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].
azelaic acidLabel Image
|FINACEA azelaic acid gel|
|Labeler — A-S Medication Solutions (830016429)|
|A-S Medication Solutions||830016429||RELABEL (50090-4473)|
Revised: 02/2023 A-S Medication Solutions
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.