Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g benzoyl peroxide clindamycin, based on mg/m2) revealed no effects on fertility or mating ability.Ĭ. Studies have not been performed with benzoyl peroxide clindamycin or benzoyl peroxide to evaluate the effect on fertility. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in Salmonella typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test. Genotoxicity studies were not conducted with benzoyl peroxide clindamycin. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. The clinical significance of this is unknown. After dispensing, store at room temperature up to 77 degrees F and use within 60 daysīenzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Store unreconstituted product at 68 to 77 degrees F excursions permitted to 59 to 86 degrees F Store reconstituted product at room temperature (77 degrees F) Product can be stored for up to 90 days after the day on which it was compounded Store at room temperature (up to 77 degrees F) Prior to dispensing, store in refrigerator (36 to 46 degrees F) May be stored at room temperature not exceeding 77 degrees F for up to 3 months
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