Renova 0.02%

Renova 0.02%

INDICATIONS

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

RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 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 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 cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigmes, telangiectasia, skin laxity, keratinocytic atypia, melanocyte atypia, or dermal elastosis.
  • RENOVA (tretinoin cream) 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.
  • Patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time.
  • Neither the safety nor the effectiveness of RENOVA (tretinoin cream) for the prevention or treatment of actinic keratoses or skin neoplasms has been established,
  • Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 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 cream) if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy,
  • Do NOT use RENOVA (tretinoin cream) if the patient is sunburned or if the patient has eczema or other chronic skin conditions of the face,
  • o NOT use RENOVA (tretinoin cream) if the patient is inherently sensitive to sunlight,
  • Do NOT use RENOVA (tretinoin cream) 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 cream) 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 faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying RENOVA (tretinoin cream) . The patient should apply a small pearl-sized (about Va inch or 5 millimeter diameter) amount of cream to cover the entire affected area lightly. Caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of RENOVA (tretinoin cream) may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of fine facial wrinkling may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen.

With discontinuation of RENOVA (tretinoin cream) therapy, some patients may lose the mitigating effects of RENOVA (tretinoin cream) on fine facial wrinkles. The safety and effectiveness of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 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 cream) may use cosmetics but the areas to be treated should be cleansed before the medication is applied. (See PRECAUTIONS section.)

HOW SUPPLIED

RENOVA® (tretinoin cream), 0.02% is available in tubes containing 40 grams (NDC 0062-0187-02).

Storage: Store at 25° (77°F), excursions permitted to 15-30°C (59°-86°F).

QUESTIONS: Physicians and Pharmacists can call 1 -800-426-7762, from 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday.

Distributed by: OrthoNeutrogena, DIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC. Los Angeles, CA 90045. Revised January 2006. FDA rev date: 7/14/2002

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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