Indication and Important Safety Information
- 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.
Reference: 1. Thielitz A, Gollnick H. Topical retinoids in acne vulgaris: update on efficacy and safety. Am J Clin Dermatol. 2008;9(6):369-381.
RETIN-A MICRO is a trademark of Ortho Dermatologics’ affiliated entities. © All Rights Reserved. RAM.0018.USA.17