Benzac AC 2.5/Benzac AC 5 Special Precautions

General: For external use only. If severe irritation develops discontinue use and institute appropriate therapy. After the reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.
Information for Patients: A mild burning sensation will probably be felt on first application and some reddening and peeling of the skin will occur within a few days. During the first weeks of treatment a sudden increase in peeling will occur in most patients. This is not harmful and will normally subside within a day or two if treatment is temporarily discontinued. If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue use or to discontinue use altogether.
Avoid contact with eyes, eyelids, mouths and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult the physician. May contain benzoic acid as a degradation product of benzoyl peroxide.
Repeated exposure to sunlight or UV radiation should be avoided.
Due to the risk of sensitisation, benzoyl peroxide gel or lotion should not be applied on damaged skin.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test), and there is no published data indicating it impairs fertility.
Pregnancy: Teratogenic Effects: Animal reproduction studies have not been conducted with benzoyl peroxide. It is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Benzoyl peroxide should be used by a pregnant woman only if clearly needed. In widespread clinical use for the cutaneous treatment of acne vulgaris, at concentrations up to 10% w/w for several decades, benzoyl peroxide has never been associated with effects on these parameters in humans. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.
Nursing Mothers: 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 and the preparation should not be applied on the chest to avoid accidental transfer to the infant.
Pediatric Use: Safety and effectiveness in children have not been established.
Effects on Ability to Drive and Use Machines: Based on the pharmacodynamics profile and extensive clinical experience, performance related to driving and using machines should not be affected during treatment with benzoyl peroxide.