"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
If itching, redness, burning, swelling or undue dryness occurs, discontinue use.
For external use only. Not for ophthalmic use. Keep away from eyes and mucosae. Very fair individuals should begin with a single application at bedtime allowing overnight medication. May bleach colored fabrics. Keep this and all medications out of the reach of children.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy Category C
Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.
Safety and effectiveness in pediatric patients under the age of 12 have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/28/2009
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