Retin-A Micro (Tretinoin Topical) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Retin-A Micro^® (tretinoin gel) microsphere, 0.1% tube: 2 g sample (NDC 0062-0190-01), 20g (NDC 0062-0190-02), 45g (NDC 0062-0190-03).

Retin-A Micro^® (tretinoin gel) microsphere, 0.1% 50g (NDC 0062-0190-11)

Retin-A Micro^® (tretinoin gel) microsphere, 0.04% tube: 2g sample (NDC 0062-0204-01), 20g (NDC 0062-0204-02), 45g (NDC 0062-0204-03).

Retin-A Micro^® (tretinoin gel) microsphere, 0.04% pump: 50g (NDC 0062-0204-11)

Storage Conditions

Store at 15° - 25° C (59° - 77°F).

Rx only.

Ortho Dermatologics^™
Marketed by: Ortho Dermatologics^™
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Los Angeles, CA 90045

RETIN-A MICRO^® is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.
MICROSPONGE^® is a registered trademark of AMCOL International Corporation

Manufactured by: Ortho Pharmaceutical
a division of Janssen Ortho LLC.
Manati, Puerto Rico 00674-0463

© OMJPI 2010

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RETIN-A MICRO ^® (tretinoin gel) microsphere, 0.1% and 0.04%