TESTOSTERONE- testosterone solution 
Lupin Pharmaceuticals, Inc.

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MEDICATION GUIDE

Testosterone (tes TOS ter one) Topical Solution, for topical use CIII

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

1. Testosterone topical solution 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 topical solution 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 topical solution.

Children

Signs and symptoms of early puberty in a child when they come in direct contact with testosterone topical solution may include:

Abnormal sexual changes:

Behavior problems:

Women

Signs and symptoms in women when they come in direct contact with testosterone topical solution may include:

Stop using testosterone topical solution 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 topical solution:

2. To lower the risk of transfer of testosterone topical solution from your body to others, follow these important instructions:

What is testosterone topical solution?

Do not use testosterone topical solution if you:

Women who are pregnant or who may become pregnant should avoid contact with the area of the skin where testosterone topical solution has been applied.

Before using testosterone topical solution, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using testosterone topical solution with other medicines can affect each other.

Especially tell your healthcare provider if you take:

How should I use testosterone topical solution?

What are the possible side effects of testosterone topical solution?

Testosterone topical solution can cause serious side effects including:

See also "What is the most important information I should know about testosterone topical solution?"

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of testosterone topical solution 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 topical solution. 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 topical solution.

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

What are the ingredients in testosterone topical solution?

Active ingredient: testosterone.

Inactive ingredients: ethanol, isopropyl alcohol, octisalate, and povidone.

The bottle and the applicator cup are not made with natural rubber latex.

For more information, go to www.lupinpharmaceuticals.com or call 1-800-399-2561.

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

INSTRUCTIONS FOR USE

Testosterone (tes TOS ter one) Topical Solution, for topical use, CIII

Read this Instructions for Use for testosterone topical solution 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 treatment.

Applying Testosterone Topical Solution:

Figure 1

Testosterone Topical Solution Figure 1

Find Your Dose as Prescribed by Your Healthcare Provider
Each application equals 1 press (depression) of the pump.

30 mg
Apply 1 application one time to one armpit only (left or right).
60 mg
Apply 2 applications: one to the left armpit and then one to the right armpit.
90 mg
Apply 3 applications: one to the left and one to the right armpit, wait for the product to dry, and then apply again one to the left or right armpit.
120 mg
Apply 4 applications: one to the left and one to the right armpit, wait for the product to dry, and then apply again one to the left and one to the right armpit.
Figure 2

Figure 2

Figure 3

Figure 3

How should I store testosterone topical solution?

Keep testosterone topical solution and all medicines out of the reach of children.

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) – 454 775

India

March 25, 2019                                                                                               ID#: 259999

Revised: 3/2019
Lupin Pharmaceuticals, Inc.