Calcipotriene 0.005% 60 Gram Foam (Page 3 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Calcipotriene foam, 0.005%, is supplied as follows:

60 g aluminum can NDC 73352-886-60

16.2 Storage and Handling

  • 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.

17 PATIENT COUNSELING INFORMATION

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.

Distributed by:
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:
  • are pregnant or planning to become pregnant. It is not known if calcipotriene foam will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if calcipotriene foam passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with calcipotriene foam.
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?
  • Use calcipotriene foam exactly as your healthcare provider tells you to use it. See the detailed “Instructions for Use” at the end of this leaflet for directions about how to apply calcipotriene foam the right away.
  • Calcipotriene foam is usually applied to the affected skin areas 2 times each day.
  • For your scalp, apply calcipotriene foam when your hair is dry.
  • Talk with your healthcare provider if your skin does not improve after 8 weeks of treatment with calcipotriene foam.
  • Wash your hands after applying calcipotriene foam unless you are using the medicine to treat your hands.
WHAT SHOULD I AVOID WHILE USING CALCIPOTRIENE FOAM?
  • Calcipotriene foam is flammable. Avoid fire, flame, and smoking during and right after you apply calcipotriene foam.
  • Avoid getting calcipotriene foam on your face or in or near your eyes. If calcipotriene foam gets on your face or in your eyes, rinse well with water.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF CALCIPOTRIENE FOAM?
Calcipotriene foam may cause serious side effects, including:
  • Too much calcium in your blood. Your healthcare provider may tell you to stop using calcipotriene foam until your calcium levels become normal.
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?
  • Store calcipotriene foam at room temperature, between 68°F to 77°F (20C° to 25°C).
  • Do not store calcipotriene foam in the refrigerator or freezer.
  • Do not expose calcipotriene foam to heat or store at temperatures above 120°F (49°C).
  • Do not puncture or burn the calcipotriene foam can.
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.
Distributed by:
Trifluent Pharma LLC
San Antonio, TX

Instructions for Use Calcipotriene Foam, 0.005%

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.

Important Information:

  • 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.

Figure A

Step 2: Shake the can of calcipotriene foam before use. See Figure B.

Figure B

Step 3: Turn the can of calcipotriene foam upside down and press the nozzle. See Figure C.

Figure C

Step 4. Dispense a small amount of calcipotriene foam into the palm of your hand. See Figure D.

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

Figure EFigure 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.

Figure G
(click image for full-size original)

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by: Trifluent Pharma LLC San Antonio, TX

Issued: 07/2020

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