Renova

INDICATIONS

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

RENOVA (tretinoin cream) 0.05% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs (see bullet point 3 for populations in which effectiveness has not been established). RENOVA (tretinoin emollient cream 0.05%) DOES NOT ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blinded, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams.

  • RENOVA (tretinoin emollient cream 0.05%) 0.05% has NOT DEMONSTRATED A 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 (tretinoin emollient cream 0.05%) should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fine wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sunlight avoidance program alone.
  • The effectiveness of RENOVA (tretinoin emollient cream 0.05%) 0.05% in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50 years 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 (tretinoin emollient cream 0.05%) 0.05%. Thus the effectiveness and safety of RENOVA (tretinoin emollient cream 0.05%) 0.05% in these populations are not known at this time.
  • Neither the safety nor the effectiveness of RENOVA (tretinoin emollient cream 0.05%) for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
  • Neither the safety nor the efficacy of using RENOVA (tretinoin emollient cream 0.05%) 0.05% 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.)

DOSAGE AND ADMINISTRATION

  • Do NOT use RENOVA (tretinoin emollient cream 0.05%) if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy,
  • Do NOT use RENOVA (tretinoin emollient cream 0.05%) if the patient is sunburned or if the patient has eczema or other chronic skin conditions of the face,
  • Do NOT use RENOVA (tretinoin emollient cream 0.05%) if the patient is inherently sensitive to sunlight,
  • Do NOT use RENOVA (tretinoin emollient cream 0.05%) if the patient is also taking drug(s) 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 (tretinoin emollient cream 0.05%) should be applied to the face once a day in the evening, 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 (tretinoin emollient cream 0.05%) . The patient should apply a pea-sized amount of cream to cover the entire affected face lightly. Caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of RENOVA (tretinoin emollient cream 0.05%) 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 (tretinoin emollient cream 0.05%) 0.05% 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 (tretinoin emollient cream 0.05%) 0.05% therapy, a majority of patients will lose most mitigating effects of RENOVA (tretinoin emollient cream 0.05%) 0.05% on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using RENOVA (tretinoin emollient cream 0.05%) 0.05% daily for greater than 48 weeks have not been established.

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

Patients treated with RENOVA (tretinoin emollient cream 0.05%) may use cosmetics but the areas to be treated should be cleansed before the medication is applied. (See PRECAUTIONS section.)

HOW SUPPLIED

RENOVA (tretinoin emollient cream 0.05%) is available in these sizes:

NDC 0062-0185-0020 gram tube
NDC 0062-0185-0540 gram tube
NDA 0062-0185-0360 gram tube

Storage: Store at 25°C (77°F), excursions permitted to 15-30°C (59°F-86°F). DO NOT FREEZE.

QUESTIONS: Physicians and Pharmacists can call 1-800-462-7762, from 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday.

ORTHO DERMATOLOGICAL DIVISION, A division of ORTHO-McNEIL PHARMACEUTICAL CORPORATION, Raritan, New Jersey 08869. Revised July 2000. FDA rev date: 3/20/2001

Last reviewed on RxList: 12/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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