Label: CLEASE AND TREAT- benzoyl peroxide pad and salicylic acid pad cloth

CHEMICAL STRUCTURE

Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. It has an empirical formula of C14H10O4 with a molecular weight of 242.23. Benzoyl peroxide has the following molecular structure:

Salicylic acid is the 2 hydroxy derivative of benzoic aid. It has an empirical formula of C7H6O3 with a molecular weight of 138.12. Salicylic acid has the following molecular structure:

Pediatric Use - Cleanse & Treat should not be used by children under 12 years of age.

Information for Patients - Patients should avoid unnecessary sun exposure and use a sunscreen when in sunlight. Contact with hair, fabrics, or any colored materials may result in bleaching or discoloration. Patients should avoid concomitant use of other drugs that may contribute to elevated serum salicylate levels where the potential for toxicity exists. Symptoms of salicylate toxicity may include nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea and diarrhea. In the event of salicylate toxicity, the use of Cleanse & Treat should be discontinued, fluids should be administered to promote urinary excretion and medical assistance should be obtained immediately.

Carcinogenesis, Mutagenesis, Impairment of Fertility - Data from some studies using a strain of mice highly susceptible to eveloping cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is not known. Benzoyl peroxide has not been found to be mutagenic in the Ames Salmonella Test and there are no published data suggesting that it impairs fertility. No data are available concerning potential carcinogenic or reproductive effects of salicylic acid. It has not been found to be mutagenic in the Ames Salmonella Test and there are no published data suggesting that it impairs fertility.

Pregnancy (Category C) - Animal reproduction studies have not been performed with benzoyl peroxide and it is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman. Nevertheless, benzoyl peroxide should be used by a pregnant woman only if necessary. Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent 10 times or more the maximum daily human dose of salicylic acid when applied topically as directed with Cleanse &Treat. There are no adequate and well-controlled studies in pregnant women. Nevertheless, salicylic acid should be used by a pregnant woman only if necessary.