The U.S. Food and

Drug Administration (FDA) has approved Axiron (testosterone) topical solution CIII for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone.

Safety and efficacy of Axiron in males younger than 18 years of age have not been established. Axiron is the first testosterone topical solution approved for application via an armpit (underarm) applicator.

Other forms of testosterone replacement therapy include: oral tablets, buccal tablets, subcutaneous pellets, transdermal patches, injections and topical gels applied by the hands.

Axiron Medication Guide

Read this Medication Guide before you start using Axiron and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information about Axiron

Axiron can transfer from your body to others. This can happen if other people come into contact with the area where the Axiron was applied.

Signs of puberty that are not expected (for example, pubic hair) have happened in young children who were accidentally exposed to testosterone through skin to skin contact with men using topical testosterone products like Axiron.

• Women and children should avoid contact with the unwashed or unclothed area where Axiron has been applied. If a woman or child makes contact with the application area, the contact area on the woman or child should be washed well with soap and water right away.

• To lower the risk of transfer of Axiron from your body to others, you should follow these important instructions:

  • Apply Axiron only to your armpits.

  • Wash your hands right away with soap and water after applying Axiron.

  • After the solution has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.

  • If you expect another person to have direct skin-to-skin contact with your armpits, first wash the application area well with soap and water.

Stop using Axiron and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to Axiron:

Signs and symptoms in children may include:

• enlarged penis or clitoris

• early development of pubic hair

• increased erections or sex drive

• aggressive behavior

Signs and symptoms in women may include:

• changes in body hair

• a large increase in acne