The FDA said in a statement that the product, Evamist, could cause premature puberty, nipple swelling and breast development in females, and breast enlargement in males. The main ingredient in Evamist is estrogen, and it is used to reduce hot flashes in women going through menopause.
The FDA approved Evamist in 2007. Since then, the agency received eight cases of unintended exposure in children ages 3 to 5 years old.
Evamist is sprayed on the arm between the wrist and the elbow. The FDA said children should not make contact with any areas of the skin where it has been sprayed.