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AXIRON- testosterone solution

  1. Patient Information
  2. Do Not Use Axiron If You:
  3. Before You Use Axiron, Tell Your Healthcare Provider If You:
  4. Especially Tell Your Healthcare Provider If You Take:
  5. How Should I Use Axiron?
  6. What Are The Ingredients In Axiron?
  7. Revised: 11/2013document Id:

Patient Information 

AXIRON can transfer from your body to others. This can happen if other people come into contact with the area where the AXIRON was applied.

Signs of puberty that are not expected (for example, pubic hair) have happened in young children who were accidentally exposed to testosterone through skin to skin contact with men using topical testosterone products like AXIRON.

  • Women and children should avoid contact with the unwashed or unclothed area where AXIRON has been applied. If a woman or child makes contact with the application area, the contact area on the woman or child should be washed well with soap and water right away.
  • To lower the risk of transfer of AXIRON from your body to others, you should follow these important instructions:
    • Apply AXIRONonlyto your armpits.
    • Wash your handsright awaywith soap and water after applying AXIRON.
    • After the solution 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 another person to have direct skin-to-skin contact with your armpits, first wash the application area well with soap and water.

Stop using AXIRON and call your healthcare provider right away if you

AXIRON is a prescription medicine that contains testosterone. AXIRON is used to treat adult males who have low or no testosterone.

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

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

AXIRON is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your AXIRON in a safe place to protect it. Never give AXIRON 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.

AXIRON is not meant for use in women.

Do Not Use Axiron If You: 

  • have breast cancer
  • have or might have prostate cancer
  • are pregnant or may become pregnant or are breast-feeding. AXIRON may harm your unborn or breast-feeding baby.

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

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

Before You Use Axiron, Tell Your Healthcare Provider If You: 

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

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

Using AXIRON with other medicines can affect each other.

Especially Tell Your Healthcare Provider If You Take: 

  • insulin
  • medicines that decrease blood clotting
  • corticosteroids

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of all of your 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 Axiron? 

  • It is important that you apply AXIRON exactly as your healthcare provider tells you to.
  • Your healthcare provider will tell you how much AXIRON to apply and when to apply it.
  • Your healthcare provider may change your AXIRON dose. Do not change your AXIRON dose without talking to your healthcare provider.
  • AXIRON is to be applied to the armpits only.Do not apply AXIRON to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms.
  • Do not apply AXIRON with your fingers or hands.
  • Apply AXIRON at about the same time each morning. AXIRON should be applied after showering or bathing.
  • Avoid swimming or bathing for at least 2 hours after you apply AXIRON.
  • You can use an antiperspirant or deodorant before applying AXIRON. If you use antiperspirant or deodorant, then it should be applied at least 2 minutes before you apply AXIRON.
  • AXIRON is flammable until dry. Let AXIRON dry before smoking or going near an open flame.
  • Avoid splashing in the eyes. In case of contact with eyes, flush thoroughly with water. If irritation persists,

    Store AXIRON at 15 C to 30 C (59 F to 86 F)

    When it is time to throw away the bottle, safely throw away all parts of the AXIRON dispenser including bottle applicator cup and cap. Be careful to prevent accidental exposure of children or pets.

    Keep AXIRON away from fire.

    General information about AXIRON

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AXIRON for a condition for which it was not prescribed. Do not give AXIRON to other people, even if they have the same symptoms you have. It may harm them.

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

    For more information, go to or call 1-800-545-5979.

What Are The Ingredients In Axiron? 

Active ingredient: testosterone.

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

The bottle or applicator cup does not contain latex.

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

Literature issued November 2010

Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA

PV 8161 AMP

PACKAGE LABEL Axiron Bottle 30mg 1ct

If the seal is broken before first use, contact your pharmacist

NDC 0002-1975-90

TS 1975


(testosterone) topical solution

30 mg of testosterone per pump actuation*


*Each actuation delivers 1.5 mL of solution

Multi-dose pump capable of dispensing 60 metered pump actuations.

For topical use only with enclosed applicator

Dispense the enclosed Medication Guide to each patient

Rx Only


PACKAGE LABEL     Axiron Bottle 30mg 1ct

image of package label

testosterone solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-6406(NDC:0002-1975)
Route of AdministrationTOPICALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-6406-01 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler -Physicians Total Care, Inc. (194123980)
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-6406)

Revised: 11/2013document Id: 

d857b220-9912-4908-8733-f904a6402b8eSet id: 3b40e56a-51bb-4357-8861-325bb1195049Version: 1Effective Time: 20131112Physicians Total Care, Inc.

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