TESTOSTERONE- testosterone gel 
TESTOSTERONE- testosterone gel, metered 
Upsher-Smith Laboratories, Inc.

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MEDICATION GUIDE

Testosterone (tes-TOS-te-rōn) Gel, CIII

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

What is the most important information I should know about testosterone gel?

1.
Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using testosterone gel.

Signs and symptoms of early puberty in a child may include:
  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

Testosterone gel can transfer from your body to others.

2.
Women and children should avoid contact with the unwashed or unclothed area where testosterone gel has been applied to your skin.

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 occurred through accidental exposure to testosterone gel.

Signs and symptoms of exposure to testosterone gel in children may include:
  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

Signs and symptoms of exposure to testosterone gel in women may include:
  • changes in body hair
  • a large increase in acne

To lower the risk of transfer of testosterone gel from your body to others, you should follow these important instructions:
  • Apply testosterone gel only to the areas of your shoulders and upper arms that will be covered by a short sleeve T-shirt.
  • Wash your hands right away with soap and water after applying testosterone gel.
  • After the gel 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 to have skin-to-skin contact with another person, first wash the application area well with soap and water.
  • If a woman or child makes contact with the testosterone gel application area, that area on the woman or child should be washed well with soap and water right away.

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.

Your healthcare provider will test your blood before you start and while you are taking testosterone gel.

It is not known if testosterone gel is safe or effective to treat men who have low testosterone due to aging.

It is not known if testosterone gel is safe or effective in children younger than 18 years old. Improper use of testosterone gel may affect bone growth in children.

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 your testosterone gel to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.

Testosterone gel is not meant for use in women.

Who should not use testosterone gel?

Do not use testosterone gel if you:

Talk to your healthcare provider before using this medicine if you have any of the above conditions.

What should I tell my healthcare provider before using testosterone gel?

Before you use testosterone gel, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Testosterone gel and certain other medicines you take can affect each other.

Especially, tell your healthcare provider if you take:

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use testosterone gel?

Applying testosterone gel:

Testosterone gel comes in tubes, packets, or in a pump.

Figure A
Figure A

If you are using testosterone gel tubes:

If you are using testosterone gel packets:

If you are using the testosterone gel pump:

What are the possible side effects of testosterone gel?

Testosterone gel can cause serious side effects including:

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-FDA-1088.

How should I store testosterone gel?

Keep testosterone gel and all medicines out of the reach of children.

General information about the safe and effective use of 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 that you have. It may harm them.

This Medication Guide summarizes the most important information about testosterone gel. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about testosterone gel that is written for health professionals.

For more information, go to www.upsher-smith.com or call 1-888-650-3789.

What are the ingredients in testosterone gel?

Active ingredient: testosterone

Inactive ingredients: carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine

This Medication Guide has been approved by the U.S. Food and Drug Administration.

For Medication Guides, please visit www.upsher-smith.com or call 1-888-650-3789.

Manufactured for
USL PHARMA, INC.
Denver, CO 80223

MADE IN CANADA

Revised 1016

Revised: 7/2017
Upsher-Smith Laboratories, Inc.