INDICATION AND IMPORTANT SAFETY INFORMATION

RETIN-A MICRO (tretinoin gel) microsphere is indicated for topical application in the treatment of acne vulgaris.

IMPORTANT SAFETY INFORMATION

The skin of certain individuals may become excessively dry, red, swollen or blistered during the use of RETIN-A MICRO.
Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.
If warranted, patients should temporarily reduce the amount or frequency of application, or discontinue use temporarily or altogether. If a reaction suggesting sensitivity occurs, use should be discontinued.
Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of RETIN-A MICRO, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight with the use of tretinoin.
Patients should be encouraged to use a sunscreen with a SPF of 15 or higher and protective clothing over treated areas when exposure cannot be avoided.
Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.
The most common adverse events are mild to moderate irritation (erythema, peeling, dryness, burning/stinging, or itching of the skin).
RETIN-A MICRO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and caution should be exercised in prescribing for nursing mothers. Safety and efficacy in patients under 12 have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Reference: 1. Retin-A Micro Gel Package Insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC.