RENOVA is a serious medication. It does not eliminate wrinkles or repair sun-damaged skin. It may help treat fine wrinkles, spotty discoloration, and rough feeling skin, but it does not ²cure² these conditions. RENOVA should only be used under supervision of your health care provider as part of a broad skin care program. This program should include avoiding direct sunlight (by using protective clothing and sunscreens with a minimum SPF of 15) and using other moisturizing facial creams that do not contain tretinoin.

You should use RENOVA only at bedtime. Do not use drying skin care products. Use the smallest amount of RENOVA needed and avoid getting it in your eyes, ears, nose or mouth.

RENOVA has not been studied in people who are over 50 years of age or in people with moderately or darkly pigmented skin.

What is RENOVA?
(WHAT CAN I EXPECT FROM RENOVA?)

RENOVA is a serious medication that may help treat but will not ²cure² fine wrinkles, spotty skin discoloration, and rough feeling skin.

Studies show that after 24 weeks, about 30% of the people who used RENOVA for fine wrinkles or spotty discoloration had moderate improvement, another 35% had minimal improvement and 35% had no improvement. About 16% of the people who used RENOVA for rough skin had moderate improvement, 35% had minimal improvement, and 49% had no improvement. There is no evidence that RENOVA treats coarse skin, deep wrinkles, yellowing skin, or other skin care problems.

RENOVA should be used as part of a broad skin care program. This program should include avoiding direct sunlight (by using protective clothing and sunscreens with a minimum SPF of 15) and using other moisturizing facial creams that do not contain tretinoin. Many people can achieve desired effects by using this program without using RENOVA. You should not use RENOVA until you have tried a broad skin treatment program without RENOVA.

When you use RENOVA, improvement in fine wrinkling, spotty skin discoloration and rough skin is not immediate and occurs gradually over time. Generally, you may notice some effects in 3 to 4 months. The effects are usually most noticeable at about 6 months with little additional improvement after that time. If RENOVA treatment is stopped, the improvement will gradually diminish.

The safety of using RENOVA daily for more than 48 weeks has not been established.

Who Should Not Use RENOVA?

You should not use RENOVA if you are sunburned or highly sensitive to the sun, if you have eczema, or if your skin is irritated. RENOVA can cause increased skin irritation and increased susceptibility to sunburn.

Since RENOVA may make your skin more sensitive to sunlight, you should tell your health care professional if you are also using other medicines that increase sensitivity to sunlight because you should not be using RENOVA with these medicines. These include but are not limited to: thiazides (used to treat high blood pressure), tetracyclines, fluoroquinolones or sulfonamides (used to treat infection), and phenothiazines (used to treat serious emotional problems). If you are taking any prescription medicines, non-prescription medicines or using any facial creams, check with a health care professional to make sure they do not interact with RENOVA.

Pregnancy Warning: Safe use during pregnancy has not been shown. There are reports of birth defects with laboratory animals and humans that were given tretinoin by mouth. You should not use RENOVA if you are pregnant or trying to become pregnant.

It is not known if RENOVA is passed to infants through breast milk. Safe use in children has not been shown.

The safety and effectiveness of RENOVA for people over age 50 or with darker skin coloration has not been proven.

How Should I Use RENOVA?

You should apply RENOVA to your face once a day before retiring using only enough to cover the entire affected area lightly. Gently wash your face with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying RENOVA. Apply a pea-sized amount of cream to cover your entire face. You may feel a warmth or slight stinging when RENOVA is first applied.

You must be especially careful when applying the cream to avoid your eyes, ears, nostrils, or mouth. RENOVA may cause severe redness, itching, burning, stinging, and peeling if applied to these areas.

Using larger than necessary amounts of RENOVA will not speed results and can cause an overdose. An overdose can result in red and peeling skin as well as some pain or discomfort.

You may use cosmetics after applying RENOVA. Make sure to clean your face thoroughly before applying RENOVA again.

What Should I Avoid While Using RENOVA?

RENOVA increases your sensitivity to sunlight. Avoid sunlight as much as possible. Use protective clothing and a sunscreen with a minimum SPF of 15. Do not sunbathe or use sunlamps. If you are sensitive to sunlight or have a job that requires you to be out in the sun for long periods, you must use extreme caution.

While using RENOVA, avoid any products that can dry or irritate the skin. For example, avoid products applied to the skin that contain alcohol, spices, or lime. Also, avoid cleansers, hair removal, or other products that can irritate the skin.

What Are the Possible Side Effects of RENOVA?

The most common side effects are skin reactions. Itching, red, and dry skin have been reported. So have burning, stinging, and peeling skin. These are most often mild and are most common when treatment is started.

This leaflet summarizes the most important information about RENOVA. If you would like more information, talk to your doctor or other health care provider. There is also a leaflet written for health professionals that your pharmacist can provide for you.

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