RENOVA (tretinoin emollient cream) 0.05% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyper-pigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone (see bullet point 3 for populations in which effectiveness has not been established). RENOVA DOES NOT ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTO-AGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Many patients achieve desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sun avoidance programs including sunscreens, protective clothing, and emollient creams NOT containing tretinoin.

· RENOVA has demonstrated NO MITIGATING EFFECT on significant signs of chronic sun exposure such as coarse or deep wrinkling, skin yellowing, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.

· RENOVA should only be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fine wrinkles, mottled hyper-pigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sun avoidance program alone.

· The effectiveness of RENOVA in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50years of age OR in people with moderately to heavily pigmented skin. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of RENOVA. Thus the effectiveness and safety of RENOVA in these populations are not known at this time.

· Neither the safety nor the effectiveness of RENOVA for the prevention or treatment of actinic keratoses or skin neoplasms has been established.

· Neither the safety nor the efficacy of using RENOVA daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. (See WARNINGS section.)

Two adequate and well-controlled trials were conducted involving a total of 161 evaluable patients (under 50 years of age) treated with RENOVA and 154 evaluable patients treated with the vehicle emollient cream on the face for 24 weeks as an adjunct to a comprehensive skin care and sun avoidance program, to assess the effects on fine wrinkling, mottled hyperpigmentation, and tactile skin roughness. Patients were evaluated at baseline on a 10 point scale and changes from that baseline rating were categorized as follows:

No Improvement: No change or an increase of 1 unit or more.

Minimal Improvement: Reduction of 1 unit.

Moderate Improvement: Reduction of 2 units or more.

In these trials, the fine wrinkles, mottled hyperpigmentation, and tactile roughness of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sun exposure.

The results of these assessments are as follows:

*CSP = Comprehensive skin protection and sun avoidance programs including use of sunscreens, protective clothing, and emollient cream.

Most of the improvement in these signs was noted during the first 24 weeks of therapy. Thereafter, therapy primarily maintained the improvement realized during the first 24 weeks.

A majority of patients will lose most mitigating effects of RENOVA on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin with discontinuation of a comprehensive skin care and sun avoidance program including RENOVA; however, the safety and effectiveness of using RENOVA daily for greater than 48 weeks have not been established.

· Do NOT use RENOVA if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy,

· Do NOT use RENOVA if the patient is sunburned or if the patient has eczema or other chronic skin condition(s),

· Do NOT use RENOVA if the patient is inherently sensitive to sunlight,

· Do NOT use RENOVA if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert.

RENOVA should be applied to the face once a day before retiring using only enough to cover the entire affected area lightly. Patients should gently wash their face with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying RENOVA. The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of RENOVA may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with RENOVA is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of RENOVA therapy, a majority of patients will lose most mitigating effects of RENOVA on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using RENOVA daily for greater than 48 weeks have not been established.

Application of larger amounts of medication than recommended will not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.

Patients treated with RENOVA may use cosmetics but the areas to be treated should be cleansed thoroughly before the medication is applied. (See PRECAUTIONS section.)