TESTOSTERONE- testosterone gel
Par Pharmaceutical, Inc.
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%.
Signs and symptoms of early puberty in a child when they come in direct contact with Testosterone Gel 1% may include:
Abnormal sexual changes:
acting aggressively, behaving in an angry or violent way.
Signs and symptoms in women when they come in direct contact with Testosterone Gel 1% may include:
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:
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.
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:
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:
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:
How should I use Testosterone Gel 1%?
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%?”
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:
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.
Chestnut Ridge, NY 10977
INSTRUCTIONS FOR USE
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.
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.