TESTOSTERONE- testosterone gel, metered
Actavis Pharma, Inc.
Testosterone (tes-TOS-te-rone) CIII
What is the most important information I should know about testosterone gel?
1. Testosterone gel can transfer from your body to others including, children and women. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where testosterone gel has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used testosterone gel.
Signs and symptoms of early puberty in a child when they come in direct contact with testosterone gel may include:
Abnormal sexual changes:
Stop using testosterone gel and call your healthcare provider right away if you see any signs and
symptoms in a child or a woman that may have happened through accidental touching of the area where you have applied testosterone gel.
2. To lower the risk of transfer of testosterone gel from your body to others, follow these
What is testosterone gel?
Testosterone gel is a prescription medicine that contains testosterone. Testosterone gel is used to treat adult males who have low or no testosterone due to certain medical conditions.
Testosterone gel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your testosterone gel in a safe place to protect it. Never give testosterone gel to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.
Testosterone gel is not meant for use in women.
Do not use testosterone gel if you:
Before using testosterone gel, tell your healthcare provider about all of your medical conditions
including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
Using testosterone gel with certain other medicines can affect each other. Especially, tell your healthcare
provider if you take:
How should I use testosterone gel?
What are the possible side effects of testosterone gel?
Testosterone gel can cause serious side effects including:
See “What is the most important information I should know about testosterone gel?”
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of testosterone gel include:
Other side effects include more erections than are normal for you or erections that last a long time.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of testosterone gel. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-
How should I store testosterone gel?
Keep testosterone gel and all medicines out of the reach of children.
General information about testosterone gel
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use testosterone gel for a condition for which it was not prescribed. Do not give testosterone gel to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about testosterone gel that is written for health professionals.
What are the ingredients in testosterone gel?
Active ingredients: testosterone
Inactive ingredients: butylated hydroxytoluene, carbomer 1382, dehydrated alcohol, isopropyl alcohol, oleic acid, propylene glycol, purified water, and trolamine.
Actavis Laboratories UT, Inc.
Salt Lake City, UT 84108 USA
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Rev. B 5/2019
For more information about testosterone gel, call 1-888-838-2872.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2019