Medication Guide

TESTOSTERONE GEL 1% CIII

(tes-TOS-te-ron) for topical use

What is the most important information I should know about Testosterone Gel 1%?

1. Testosterone Gel 1 % 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% 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%.

Children

Signs and symptoms of early puberty in a child when they come in direct contact with Testosterone Gel 1% may include:

Abnormal sexual changes:

• enlarged penis or clitoris.
• early growth of hair near the vagina or around the penis (pubic hair).
• erections or acting out sexual urges (sex drive).

Behavior problems:

• acting aggressively, behaving in an angry or violent way.

Women

Signs and symptoms in women when they come in direct contact with Testosterone Gel 1% may include:

• changes in body hair
• an abnormal increase in pimples (acne).

Stop using Testosterone Gel 1% and call your healthcare provider right away ifyou 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%.

To lower the risk of transfer of Testosterone Gel 1% from your body to others, follow these important instructions:

• Apply Testosterone Gel 1% only to areas of your shoulders, and upper arms, or stomach area (abdomen) that will be covered by a short sleeve t-shirt. 
• Wash your hands right away with soap and water after applying Testosterone Gel 1%.
• After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the gel off 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 child or woman touches the area where you have applied Testosterone Gel 1% , that area on the child or woman should be washed well with soap and water right away.

What is Testosterone Gel 1%?

Testosterone Gel 1% is a prescription medicine that contains testosterone. Testosterone Gel 1% 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 using Testosterone Gel 1%.
• It is not known if Testosterone Gel 1% is safe and effective to treat men who have low testosterone due to aging.
• It is not known if Testosterone Gel 1% is safe or effective in children younger than 18 years old. Improper use of Testosterone Gel 1% may affect bone growth in children.

Testosterone Gel 1% 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% in a safe place to protect it. Never give your Testosterone Gel 1% 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 1% is not meant for use in women.

Do not use Testosterone Gel 1% if you:

• have breast cancer.
• have or might have prostate cancer.
• are pregnant.  Testosterone Gel 1% may harm your unborn baby.

Women who are pregnant should avoid contact with the area of skin where Testosterone Gel 1% has been applied.

Before using Testosterone Gel 1%, tell your healthcare provider about all of your medical conditions, including if you:

• have breast cancer.
• have or might have prostate cancer.
• have urinary problems due to an enlarged prostate.
• have heart problems.
• have liver or kidney problems.
• have problems breathing while you sleep (sleep apnea).

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% with certain other medicines can affect each other.

Especially, tell your healthcare provider if you take:

• insulin
• corticosteroids
• medicines that decrease blood clotting (blood thinners)

How should I use Testosterone Gel 1%?

• See the detailed Instructions for Use for information about how to use Testosterone Gel 1% at the end of this Medication Guide.
• It is important that you apply Testosterone Gel 1% exactly as your healthcare provider tells you to.
• Your healthcare provider may change your Testosterone Gel 1% dose. Do not change your Testosterone Gel 1% dose without talking to your healthcare provider.
• Apply Testosterone Gel 1% at the same time each morning. Testosterone Gel 1% should be applied after showering or bathing.

What are the possible side effects of Testosterone Gel 1%?

Testosterone Gel 1% can cause serious side effects including:

See “What is the most important information I should know about Testosterone Gel 1%?”

• If you already have enlarged prostate, your symptoms can get worse while using Testosterone Gel. This can include:
  • increased urination at night.
  • trouble starting your urine stream.
  • having to pass urine many times during the day.
  • having an urge that you have to go to the bathroom right away.
  • having a urine accident.
  • being unable to pass urine or weak urine flow.
• Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use Testosterone Gel 1%.
• Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
• Possible increased risk of heart attack or stroke.
• In large doses Testosterone Gel 1% may lower your sperm count.
• Swelling of your ankles, feet, or body, with or without heart failure.
• Enlarged or painful breasts.
• Have problems breathing while you sleep (sleep apnea).
• Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

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% include:

• acne
• skin irritation where Testosterone Gel 1% is applied
• lab test changes
• increased prostate specific antigen (a test used to screen for prostate cancer)

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%. 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%

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Testosterone Gel 1% for a condition for which it was not prescribed. Do not give Testosterone Gel 1% 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% that is written for health professionals.

What are the ingredients in Testosterone Gel 1%?

Active ingredient: testosterone

Inactive ingredients: carbomer 940, ethanol 68.9%, isopropyl myristate, purified water and sodium hydroxide.

For more information, go to www.parpharm.com or call Par Pharmaceutical at 1-800-828-9393.

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

Distributed by:

Par Pharmaceutical

Chestnut Ridge, NY 10977

Revised 05/2019

INSTRUCTIONS FOR USE

TESTOSTERONE (tes-TOS-te-ron)

GEL 1% CIII for topical use

Read this Instructions for Use for Testosterone Gel 1% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Testosterone Gel 1% comes in packets.

• Before applying Testosterone Gel 1%, make sure that your shoulders, upper arms, or stomach are clean, dry, and there is no broken skin.

• The application sites for Testosterone Gel 1% are the shoulders, upper arms, or stomach area (abdomen) that will be covered by a short sleeve t-shirt (See Figure A). Do not apply Testosterone Gel 1% to any other parts of your body such as your penis, scrotum, chest, armpits (axillae), knees, or back.

(Figure A)

• Tear open the packet completely at the dotted line. Squeeze from the bottom of the packet to the top.

• Squeeze all of the Testosterone Gel 1% out of the packet into the palm of your hand.

• Apply Testosterone Gel 1% to the application site. You may also apply Testosterone Gel 1% from the packet directly to the application site.

• Let the application areas dry completely before putting on a t-shirt.

• Testosterone Gel 1% is flammable until dry. Let Testosterone Gel 1% dry before smoking or going near an open flame.

• Wash your hands with soap and water right away after applying Testosterone Gel 1%.

• Avoid showering, swimming, or bathing for at least 5 hours after you applyTestosterone Gel 1%.

How should I store Testosterone Gel 1%?

• Store Testosterone Gel 1% at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

• Safely throw away used Testosterone Gel 1% in household trash. Be careful to prevent accidental exposure of children or pets.

• Keep Testosterone Gel 1% away from fire.

Keep Testosterone Gel 1% and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised 05/2019