Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established.

Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application of excessive amounts of gel may result in “caking” of the gel, and will not provide incremental efficacy.

A transitory feeling of warmth or slight stinging may be noted on application. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or the frequency of application increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies.

During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. If tolerated, this should not be considered a reason to discontinue therapy.

Therapeutic results may be noticed after two weeks, but more than seven weeks of therapy are required before consistent beneficial effects are observed.

Patients treated with Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.

Retin-A Micro® (tretinoin gel) microsphere, 0.1% and 0.04%, is supplied as: 20g and 45g tubes.

Storage Conditions: Store at 15 °-25°C (59°-77°F).

ORTHO DERMATOLOGICAL., DIVISION OF ORTHO-McNeil CORPORATION, SKILLMAN, NJ 08558. Retin-A MICRO® is a trademark of Ortho-McNeil Pharmaceutical, Inc. MICROSPONGE is a trademark of Enhanced Derm Systems, Inc., Redwood City, CA. May 10, 2002. FDA rev date: 5/10/2002

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