Pregnancy There are no available data on ointment use in pregnant women to identify a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy; advise pregnant women that the ointment may increase risk of having a low birthweight infant and to use it on the smallest area of skin and for the shortest duration possible Animal data In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration to pregnant rabbits; the available data do not allow calculation of relevant comparisons between systemic exposure in animal studies to systemic exposure that would be expected in humans after topical use of the ointment Lactation There are no data regarding the presence of drug in human milk, effects on breastfed infant, or on milk production after topical ointment application to women who are breastfeeding It is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant drug or from underlying maternal condition To minimize potential exposure to breastfed infant via breast milk, use ointment on smallest area of skin and for shortest duration possible while breastfeeding; advise breastfeeding women not to apply ointment directly to nipple and areola to avoid direct infant exposure