TESTOSTERONE- testosterone gel 
TWi Pharmaceuticals, Inc.

----------

MEDICATION GUIDE

TESTOSTERONE (tes-TOS-ter-one) GEL CIII 1.62% for topical use

What is the most important information I should know about TESTOSTERONE GEL 1.62%?

1. TESTOSTERONE GEL 1.62% 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 1.62% 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 1.62%.

Children

Signs and symptoms of early puberty in a child when they come in direct contact with TESTOSTERONE GEL 1.62% may include:

Abnormal sexual changes:

Behavior problems:

Women

Signs and symptoms in women when they come in direct contact with TESTOSTERONE GEL 1.62% may include:

Stop using TESTOSTERONE GEL 1.62% 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 1.62%.

2. To lower the risk of transfer of TESTOSTERONE GEL 1.62% from your body to others, follow these important instructions:

What is TESTOSTERONE GEL 1.62%?

TESTOSTERONE GEL 1.62% is a prescription medicine that contains testosterone. TESTOSTERONE GEL 1.62% is used to treat adult males who have low or no testosterone due to certain medical conditions.

TESTOSTERONE GEL 1.62% is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your TESTOSTERONE GEL 1.62% in a safe place to protect it. Never give your TESTOSTERONE GEL 1.62% 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 1.62% is not meant for use in women.

Do not use TESTOSTERONE GEL 1.62% if you:

Before using TESTOSTERONE GEL 1.62%, 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 1.62% with certain other medicines can affect each other. Especially, tell your healthcare provider if you take:

How should I use TESTOSTERONE GEL 1.62%?

What are the possible side effects of TESTOSTERONE GEL 1.62%?

TESTOSTERONE GEL 1.62% can cause serious side effects including:

See “What is the most important information I should know about TESTOSTERONE GEL 1.62%?

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 1.62% 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 1.62%. 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.

General information about the safe and effective use of TESTOSTERONE GEL 1.62%

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TESTOSTERONE GEL 1.62% for a condition for which it was not prescribed. Do not give TESTOSTERONE GEL 1.62% 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 1.62% that is written for health professionals.

What are the ingredients in TESTOSTERONE GEL 1.62%?

Active ingredient: testosterone

Inactive ingredients: isopropyl myristate, carbomer homopolymer type C, sodium hydroxide, ethyl alcohol 75.5% v/v, and purified water.

For more information about TESTOSTERONE GEL 1.62%, call 1-844-518-2989 or go to www.twipharma.com.

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

Revised: 05/19

Revised: 10/2019
TWi Pharmaceuticals, Inc.