Calcipotriene foam, 0.005%, is supplied as follows:
|60 g aluminum can||NDC 73352-886-60|
- Store at 20°C 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 calcipotriene foam to the affected skin areas.
- Apply calcipotriene foam to the scalp when the hair is dry.
- Avoid fire, flame, and smoking during and immediately following application since calcipotriene foam is flammable.
- Avoid contact with the face and eyes. If calcipotriene 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 calcipotriene foam for 8 weeks.
- Wash your hands after applying calcipotriene foam unless your hands are the affected site.
- Do not place calcipotriene foam in the refrigerator or freezer.
Trifluent Pharma LLC
San Antonio, TX 70015061
|Patient Information Calcipotriene Foam, 0.005%|
|This Patient Information has been approved by the U.S. Food and Drug Administration.||Revised: 07/2020|
|Important: Calcipotriene Foam is for use on the skin only (topical use). Do not use Calcipotriene foam in your mouth, eyes, or vagina.|
|WHAT IS CALCIPOTRIENE FOAM?|
|Calcipotriene 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 calcipotriene foam is safe and effective in people under 4 years old.|
|Do not use calcipotriene foam if you have been told by your healthcare provider that you have a high level of calcium in your blood (hypercalcemia).|
|BEFORE USING CALCIPOTRIENE FOAM, TELL YOUR HEALTHCARE PROVIDER ABOUT ALL YOUR MEDICAL CONDITIONS, INCLUDING IF YOU:|
|Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.|
|Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.|
|HOW SHOULD I USE CALCIPOTRIENE FOAM?|
|WHAT SHOULD I AVOID WHILE USING CALCIPOTRIENE FOAM?|
|WHAT ARE THE POSSIBLE SIDE EFFECTS OF CALCIPOTRIENE FOAM?|
|Calcipotriene foam may cause serious side effects, including:|
|The most common side effects of calcipotriene foam include redness and pain of the treated skin areas.|
|These are not all the possible side effects of calcipotriene foam.|
|Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|You may also report side effects to 1-844-825-8500.|
|HOW SHOULD I STORE CALCIPOTRIENE FOAM?|
|Keep calcipotriene foam and all medicines out of the reach of children.|
|GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF CALCIPOTRIENE FOAM.|
|Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use calcipotriene foam for a condition for which it was not prescribed. Do not give calcipotriene 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 calcipotriene foam that is written for health professionals.|
|WHAT ARE THE INGREDIENTS IN CALCIPOTRIENE FOAM?|
|Active ingredient: calcipotriene|
|Inactive 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.|
|Trifluent Pharma LLC|
|San Antonio, TX|
Read this Instructions for Use before you start using calcipotriene 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.
- Calcipotriene foam is for use on the skin only (topical use). Do not use calcipotriene foam in your mouth, eyes, or vagina.
- Avoid getting calcipotriene foam on your face or in your eyes. If you accidentally get calcipotriene foam on your face or in your eyes, rinse well with water.
How to apply calcipotriene foam to your body:
Follow your healthcare providers instructions on how much calcipotriene foam to use and where to use it. Wash your hands after applying calcipotriene foam unless you are treating areas on your hands.
Step 1. Before applying calcipotriene 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 calcipotriene foam before use. See Figure B.
Step 3: Turn the can of calcipotriene foam upside down and press the nozzle. See Figure C.
Step 4. Dispense a small amount of calcipotriene foam into the palm of your hand. See Figure D.
Step 5. Use enough calcipotriene foam to cover the affected area with a thin layer. Gently rub the foam into the affected area until it disappears into the skin. See Figures E and F
How to apply calcipotriene foam to your scalp:
Step 6. Apply calcipotriene 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 calcipotriene foam.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by: Trifluent Pharma LLC San Antonio, TX
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