Tretinoin is a form of vitamin A that helps the skin renew itself.

Refissa (for the skin) is used to treat acne, to smooth rough facial skin, and to reduce the appearance of fine wrinkles and mottled skin discoloration.

Refissa may also be used for purposes not listed in this medication guide.

Avoid getting this medication in your eyes, mouth, vagina, or in the creases of your nose.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use on sunburned skin, or skin affected by eczema.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after applying Refissa. Before applying, clean and dry the skin area to be treated. Applying this medicine to wet skin may cause skin irritation.

Do not wash the treated area or apply other skin products for at least 1 hour after applying Refissa.

Refissa should be used as part of a complete skin care program that includes avoiding sunlight and using an effective sunscreen and protective clothing.

It may take up to several weeks before your skin improves. Keep using the medication as directed and tell your doctor if your symptoms do not improve. If you are using Refissa to treat acne, your condition may get slightly worse for a short time.

Call your doctor if skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.

Use this medicine for the full prescribed length of time, even if you think it is not working.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Refissa gel is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

You should not use Refissa if you are allergic to it.

Do not give Refissa to a child without medical advice. Some brands of tretinoin topical are not approved for use in anyone under 18.

Tell your doctor if you have ever had:

• eczema; or

• an allergy to fish (the gel may contain ingredients derived from fish).

It is not known whether Refissa will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid exposure to sunlight or tanning beds. Refissa can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors, even on a cloudy day.

Avoid getting this medication in your eyes, mouth, vagina, or in the creases of your nose.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid using other medications on the areas you treat with Refissa unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Refissa may cause serious side effects. Call your doctor at once if you have:

• severe burning, stinging, or irritation of treated skin;

• severe skin dryness; or

• severe redness, swelling, blistering, peeling, or crusting.

Your skin may be more sensitive to weather extremes such as cold and wind while using Refissa.

Common side effects of Refissa may include:

• skin pain, redness, burning, itching, or irritation;

• sore throat;

• mild warmth or stinging where the medicine was applied; or

• changes in color of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not use skin products that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid unless otherwise directed by your doctor. These products can cause severe skin irritation if used with Refissa.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.