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Indication

RETIN-A MICRO® (tretinoin) Gel microsphere, 0.08% 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 as a result of the use of tretinoin. Patients should be encouraged to use a sunscreen with an 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.
  • In clinical studies, the most common adverse reactions to RETIN-A MICRO were mild or moderate irritation (erythema, peeling, dryness, burning/stinging of the skin). 6% of patients using RETIN-A MICRO 0.1% and 1.3% of patients using RETIN-A MICRO 0.04% discontinued due to irritation.
  • RETIN-A MICRO should be used in 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.

Click here for Full Prescribing Information.

References: 1. Thielitz A, Gollnick H. Topical retinoids in acne vulgaris: update on efficacy and safety.Am J Clin Dermatol.
2008;9(6):369-381. 2. Nighland M, Yusuf M, Wisniewski S, Huddleston K, Nyirady J. The effect of simulated solar UV irradiation on tretinoin in tretinoin gel microsphere 0.1% and tretinoin gel 0.025%. Cutis. 2006;77(5):313-316. 3. Retin-A Micro Gel Package Insert. Bridgewater,
NJ: Valeant Pharmaceuticals North America LLC