AndroGel is approved for men 18 years and older. The hormones called androgens (which are in AndroGel) are not for men with breast cancer or known or suspected prostate cancer.

AndroGel is not indicated for use in women, has not been evaluated in women, and must not be used by women.

Pregnant women should avoid skin contact with AndroGel application sites in men. Testosterone may cause fetal harm. In the event that unwashed or unclothed skin to which AndroGel has been applied does come in direct contact with the skin of a pregnant woman, the general area of contact on the woman should be washed with soap and water as soon as possible.

In vitro studies show that residual testosterone is removed from the skin surface by washing it with soap and water.

AndroGel should not be used by patients with known hypersensitivity to any of its ingredients, including testosterone USP that is chemically synthesized from soy.