Full US Prescribing Information
Indication Statement for applicable product
RETIN-A MICRO® (tretinoin gel) microsphere, 0.04% and 0.1% are indicated for topical application in the treatment of acne vulgaris.
Important Safety Information:
RETIN-A MICRO® (tretinoin gel) microsphere, 0.04% and 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components. The skin of certain individuals may become excessively dry, red, swollen or blistered. If warranted, these individuals should temporarily reduce the amount or frequency of application, or discontinue use temporarily or all together. Patients should be encouraged to minimize exposure to sunlight, including sunlamps, and to use a sunscreen with a SPF of 15 or higher and protective clothing. The most common adverse reactions to RETIN-A MICRO 0.04% and 0.1% were limited to mild or moderate irritation of the skin. 1.3% of patients using RETIN-A MICRO 0.04% and 6% of patients using RETIN-A MICRO 0.1% discontinued due to irritation. RETIN-A MICRO 0.04% and 0.1% showed a visible reduction in total mean lesion count in as little as 2 weeks with full benefits seen after 7 weeks.
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