SORILUX (calcipotriene) Foam, 0.005%, is supplied as follows:
|60 g aluminum can||NDC 51862-376-60|
|120 g aluminum can||NDC 51862-376-12|
- Store at 20ºC to 25°C (68°F to 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F).
- Flammable. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).
- Keep out of reach of children.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform the patient to adhere to the following instructions:
- Apply SORILUX Foam to the affected skin areas.
- Apply SORILUX Foam to the scalp when the hair is dry.
- Avoid fire, flame, and smoking during and immediately following application since SORILUX Foam is flammable.
- Avoid contact with the face and eyes. If SORILUX Foam gets on the face or in or near their eyes, rinse thoroughly with water.
- Talk to your doctor if your skin does not improve after treatment with SORILUX Foam for 8 weeks.
- Wash your hands after applying SORILUX Foam unless your hands are the affected site.
- Do not place SORILUX Foam in the refrigerator or freezer.
SORILUX is a registered trademark of Mayne Pharma LLC.
Greenville, NC 27834140828
|Patient Information SORILUX (SOR-i-lux)(calcipotriene) Foam, 0.005%|
|This Patient Information has been approved by the U.S. Food and Drug Administration.||Revised: 11/2019|
|Important: SORILUX Foam is for use on the skin only (topical use). Do not use SORILUX Foam in your mouth, eyes, or vagina.|
|WHAT IS SORILUX FOAM? SORILUX Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis of the scalp and body in people 4 years of age and older.It is not known if SORILUX Foam is safe and effective in people under 4 years old.|
|Do not use SORILUX Foam if you have been told by your healthcare provider that you have a high level of calcium in your blood (hypercalcemia).|
|BEFORE USING SORILUX FOAM, TELL YOUR HEALTHCARE PROVIDER ABOUT ALL YOUR MEDICAL CONDITIONS, INCLUDING IF YOU: |
| HOW SHOULD I USE SORILUX FOAM? |
| WHAT SHOULD I AVOID WHILE USING SORILUX FOAM? |
|WHAT ARE THE POSSIBLE SIDE EFFECTS OF SORILUX FOAM?SORILUX Foam may cause serious side effects, including: |
| HOW SHOULD I STORE SORILUX FOAM? |
|GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF SORILUX FOAM. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SORILUX Foam for a condition for which it was not prescribed. Do not give SORILUX Foam to other people even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about SORILUX Foam that is written for health professionals.|
|WHAT ARE THE INGREDIENTS IN SORILUX FOAM?Active ingredient: calcipotrieneInactive ingredients: cetyl alcohol, dibasic sodium phosphate, dl-α-tocopherol, edetate disodium, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, stearyl alcohol, and white petrolatum. The foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.Distributed by:Mayne Pharma Greenville, NC 27834SORILUX is a registered trademark of Mayne Pharma LLC.|
Read this Instructions for Use before you start using SORILUX Foam and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
- SORILUX Foam is for use on the skin only (topical use). Do not use SORILUX Foam in your mouth, eyes, or vagina.
- Avoid getting SORILUX Foam on your face or in your eyes. If you accidentally get SORILUX Foam on your face or in your eyes, rinse well with water.
How to apply SORILUX Foam to your body:
Follow your healthcare providers instructions on how much SORILUX Foam to use and where to use it. Wash your hands after applying SORILUX Foam unless you are treating areas on your hands.
Step 1. Before applying SORILUX Foam for the first time, break the tiny plastic piece at the base of the can’s rim by gently pushing back (away from the piece) on the nozzle. See Figure A.
Step 2: Shake the can of SORILUX Foam before use. See Figure B.
Step 3: Turn the can of SORILUX Foam upside down and press the nozzle. See Figure C.
Step 4. Dispense a small amount of SORILUX Foam into the palm of your hand. See Figure D.
How to apply SORILUX Foam to your scalp:
Step 6. Apply SORILUX Foam to your scalp when your hair is dry. Part your hair and apply directly on the affected area. See Figure G. Wash your hands after applying SORILUX Foam.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by: Mayne Pharma , Greenville, NC 27834
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