Tazarotene (Page 4 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied:

Tazarotene Foam, 0.1% (1 mg/g) is a white to off-white foam, supplied as follows:

50-g aluminum can NDC 68308-685-50

Storage and Handling:

  • Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP-controlled room temperature.
  • Store upright.
  • Protect from freezing.
  • Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).
  • Shake can before use. Hold can at an upright angle and press firmly to dispense.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information).

Inform the patient of the following:

  • Fetal risk associated with Tazarotene Foam for females of childbearing potential. Advise patients to use an effective method of contraception during treatment to avoid pregnancy. Advise the patient to stop medication if she becomes pregnant and call her doctor.
  • If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides.
  • Do not place Tazarotene Foam in the freezer.
  • Avoid exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sun lamps.
  • Avoid contact with the eyes. If Tazarotene Foam gets in or near their eyes, to rinse thoroughly with water.
  • Wash their hands after applying Tazarotene Foam.
  • Avoid fire, flame, or smoking during and immediately following application since Tazarotene Foam is flammable.
  • Keep out of the reach of children.
  • Not for ophthalmic, oral, or intravaginal use.

Distributed by:
Mayne Pharma
Greenville, NC 27834

141190

Pharmacist-Detach here and Give Instructions to Patient

Patient Information

Tazarotene Foam

IMPORTANT: For skin use only. Do not get Tazarotene Foam in your eyes, mouth, or vagina.

Read the Patient Information that comes with Tazarotene Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

What is Tazarotene Foam?

Tazarotene Foam is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older.

It is not known if Tazarotene Foam is safe and effective in children under 12 years of age.

Who should not use Tazarotene Foam?

Do not use Tazarotene Foam if you are pregnant or plan to become pregnant. Tazarotene Foam may harm your unborn baby, if used during pregnancy.

If you are a female who can become pregnant:

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

Stop using Tazarotene Foam and call your doctor right away if you become pregnant during treatment with Tazarotene Foam.

What should I tell my doctor before using Tazarotene Foam?

Before you use Tazarotene 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 you sensitive to light.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. See “Who should not use Tazarotene Foam?”
  • 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 Tazarotene Foam or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you use Tazarotene Foam.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you:

  • use other medicines or products that make your skin dry
  • take other medicines that may increase your sensitivity to sunlight

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I use Tazarotene Foam?

  • Use Tazarotene Foam exactly as your doctor tells you to. Do not use more Tazarotene 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 Tazarotene Foam during a normal menstrual period to help assure that you are not pregnant when you begin use. See “Who should not use Tazarotene Foam?”
  • Tazarotene Foam is flammable. Avoid fire, flame, and smoking during and right after you apply Tazarotene Foam.
  • Gently clean the affected area (face and/or upper trunk) with a mild cleanser and dry completely before using Tazarotene Foam.
  • Apply Tazarotene Foam one time each day, before going to bed, to the affected areas (face and/or upper trunk) where you have acne lesions. Use enough foam to cover the entire affected area with a thin film of Tazarotene Foam.
  • Keep Tazarotene Foam away from your eyes, mouth, and vagina. If Tazarotene Foam comes into contact with your eyes, rinse them well with water.
  • Wash your hands after applying Tazarotene Foam.
  • If you use too much Tazarotene Foam, you may get redness, peeling, or skin irritation in the treated area. Call your doctor if this happens, or if you accidentally swallow Tazarotene Foam.
  • Follow your doctor’s directions for other routine skin care and the use of make-up.
  • You may also use a moisturizer as needed.

Instructions for applying Tazarotene Foam

1. Shake the Tazarotene Foam can before use.

2. Remove cap from can. Nozzle should be lined up with black mark on rim of can. If black mark is not lined up with the nozzle, twist nozzle to line up with black mark. See Figure A.

Figure AFigure A

3. Hold the Tazarotene Foam can upright at a slight angle and press the nozzle. See Figure B.

Figure BFigure B

4. Dispense a small amount of Tazarotene Foam into the palm of your hand. See Figure C.

Figure CFigure C

5. Use the fingertips of your other hand to apply enough Tazarotene 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 Figure D.

Figure D
(click image for full-size original)

6. Wash hands after applying Tazarotene Foam. See Figure E.

Figure EFigure E

Avoid getting Tazarotene Foam in your eyes, mouth, or vagina.

What should I avoid while using Tazarotene Foam?

  • Avoid using abrasive soaps or cleansers that might dry or irritate your skin, unless your doctor tells you it is ok.
  • Avoid sunlight. Tazarotene 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 in sunlight.
  • Avoid using Tazarotene Foam if you have a sunburn. If you have a sunburn, wait until it is fully healed before using Tazarotene Foam.
  • Talk to your doctor before using Tazarotene Foam if you are sensitive to sunlight, take medications that increase your sensitivity to sunlight, or you must spend a lot of time in the sun for your job.
  • Avoid weather extremes, such as wind and cold, because they may irritate your skin more while you are using Tazarotene Foam.

What are the possible side effects of Tazarotene Foam?

Tazarotene Foam may harm your unborn baby, if used during pregnancy.

The most common side effects of Tazarotene Foam are:

  • burning or stinging
  • dry skin
  • red skin
  • peeling or flaking skin

Sometimes these symptoms can become severe and may be uncomfortable. Tell your doctor if these side effects become uncomfortable for you. Your doctor may tell you to stop using Tazarotene Foam until your skin heals and your symptoms improve, or to use Tazarotene Foam less often to help you tolerate it better.

These are not all the possible side effects of Tazarotene Foam. For more information, ask your doctor or pharmacist.

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 Mayne Pharma at 1-844-825-8500.

How should I store Tazarotene Foam?

  • Store Tazarotene Foam at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Store Tazarotene Foam upright.
  • Do not freeze Tazarotene Foam.
  • Tazarotene Foam is flammable. Keep the can away from fire and heat. Do not spray Tazarotene Foam near fire or direct heat.
  • Do not puncture the can or throw it into a fire, even if the can is empty.

Keep Tazarotene Foam and all medicines out of the reach of children. General Information about Tazarotene Foam

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Tazarotene Foam for a condition for which it was not prescribed. Do not give Tazarotene Foam to other people even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Tazarotene Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Tazarotene Foam that is written for health professionals.

What are the ingredients in Tazarotene Foam?

Active ingredient: tazarotene

Inactive ingredients: butylated hydroxytoluene, ceteareth-12, citric acid anhydrous, diisopropyl adipate, light mineral oil, potassium citrate monohydrate, potassium sorbate, purified water, and sorbic acid. The foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by:
Mayne Pharma
Greenville, NC 27834

01/2021

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