Safety and Side Effects


Safety and Side Effects of FABIOR Foam

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Most insured, eligible patients pay $0 for their prescription for FABIOR Foam.

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Just because you’re an adult doesn’t mean you can’t get acne.

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Safety and side effects of FABIOR Foam

You may experience some burning and stinging, redness, dryness, or peeling. In clinical trials, these effects typically resolved with continued use of FABIOR Foam in most patients and generally did not stop patients from using the medication.

You may find it helpful to use a moisturizer.

Talk with your doctor about your skin-care routine and any side effects you experience. It may take time to find the right medication routine for your skin, so don’t give up!

How to use FABIOR Foam

Use FABIOR Foam exactly as your doctor tells you to. Do not use more FABIOR Foam than prescribed and do not use it more often than your doctor tells you to.

  • If you are a female and have menstrual periods, begin using FABIOR Foam during a normal menstrual period to help ensure that you are not pregnant when you begin use.
  • FABIOR Foam is flammable. Avoid fire, flame, and smoking during and right after using FABIOR Foam
  • Gently clean the affected area (face and/or upper trunk) with a mild cleanser and dry completely before using FABIOR Foam
  • Use FABIOR Foam once a day at bedtime. Apply FABIOR Foam to the affected area (face and/or upper trunk) where you have lesions. Use enough foam to cover the entire affected area with a thin film of FABIOR Foam
  • Keep FABIOR Foam away from your eyes, mouth, and vagina. If FABIOR Foam comes into contact with your eyes, rinse them well with water
  • Wash your hands after applying FABIOR Foam
  • If you use too much FABIOR Foam, you may get redness, peeling, or skin irritation in the treated area. Call your doctor if this happens, or if you accidentally swallow FABIOR Foam
  • Follow your doctor’s directions for other routine skin care and the use of makeup
  • You may also use a moisturizer as needed

While using FABIOR Foam

  • Avoid using abrasive soaps or cleansers that might dry or irritate your skin, unless your doctor tells you it is OK
  • Avoid sunlight. FABIOR Foam can make your skin sensitive to sunlight and the light from sunlamps or tanning beds. You could get a sunburn. Use sunscreen and protective clothing during the day if you must be outdoors
  • Avoid using FABIOR Foam if you have a sunburn. Wait until your sunburn is fully healed before using FABIOR Foam
  • Talk to your doctor before using FABIOR Foam if you are sensitive to sunlight, taking medications that increase your sensitivity to sunlight, or if your job requires you to spend a lot of time in the sun
  • Avoid weather extremes, such as wind and cold, while using FABIOR Foam because they may be more irritating to your skin
  • Please tell your doctor if you are pregnant or plan to become pregnant

Storage and Handling Instructions for FABIOR Foam

  • Store FABIOR Foam at room temperature between 60° F and 77° F (20° C to 25° C)
  • Store FABIOR Foam upright
  • Do not freeze FABIOR Foam
  • FABIOR Foam is flammable. Keep the can away from fire and heat. Do not spray FABIOR Foam near fire or direct heat
  • Do not puncture the can or throw it into a fire, even if the can is empty

Keep FABIOR Foam and all medicines out of the reach of children.

Indication

FABIOR Foam is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

For more information, please see full Prescribing Information and Patient Information Leaflet

Important Safety Information

Do not use FABIOR Foam if you are pregnant or plan to become pregnant. FABIOR Foam may harm your unborn baby.

If you are a female who can become pregnant:

  • Use an effective method of birth control during treatment with FABIOR Foam. Talk with your doctor about birth control methods that are right for you
  • Your doctor should do a blood or urine pregnancy test within 2 weeks before you begin to use FABIOR Foam to be sure you are not pregnant
  • If you have menstrual periods, begin using FABIOR Foam during a normal menstrual period to help assure that you are not pregnant when you begin use. Stop using FABIOR Foam and call your doctor right away if you become pregnant during treatment with FABIOR Foam

Before you use FABIOR Foam, tell your doctor if you:

  • or a family member have or had skin cancer
  • have eczema
  • have had a reaction to topical products in the past
  • have any condition that makes your skin sensitive to natural or artificial sunlight
  • must spend a lot of time in the sun for your job
  • have any other medical conditions
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if tazarotene passes into your breast milk. You and your doctor should decide if you will use FABIOR Foam or breastfeed. You should not do both

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you use other medicines or products that make your skin dry or take other medicines that may increase your sensitivity to natural or artificial sunlight.

Use FABIOR Foam exactly as your doctor tells you to. Do not use more FABIOR Foam than prescribed and do not use it more often than your doctor tells you to.

FABIOR Foam is flammable. Avoid fire, flame, and smoking during and after you apply FABIOR Foam.

The most common side effects of FABIOR Foam are burning or stinging, dry skin, red skin, or peeling or flaking skin. Sometimes these symptoms can become severe and may be uncomfortable. Your doctor will tell you to stop using FABlOR Foam until your skin heals and your symptoms improve, or to use FABIOR Foam less often to help you tolerate it better. Tell your doctor if these side effects become uncomfortable for you. These are not all the possible side effects of FABIOR Foam. For more information, ask your doctor or pharmacist.

Medical Information & Adverse Drug Events Reporting

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.