USE AND IMPORTANT 
SAFETY INFORMATION

Use

​

Vitality T Spray (testosterone spray) 10mg,15mg and 20mg are controlled substances, available by prescription, as a compounded product used to treat adult males who have low or no testosterone due to certain medical conditions.

​

It is not known if Vitality T Spray is safe or effective to treat men who have low testosterone due to aging.

It is not known if Vitality T Spray is safe or effective in children younger than 18 years old.

Vitality T spray is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.

 

Vitality T Spray is not meant for use in women.

​

IMPORTANT SAFETY INFORMATION

•    Secondary Exposure to Testosterone- Women and children should avoid contact with any unwashed or unclothed area where topical testosterone spray has been applied. Direct exposure may result in unwanted signs of testosterone, such as increased body hair, deepened voice, or other symptoms. In the event of exposure, immediately wash the affected area with soap and water.
•    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 topical testosterone spray. 
•     Signs and symptoms of early puberty in a child who has come in direct contact with Vitality T Spray may include:
      - Abnormal sexual changes:
          o Enlarged penis or clitoris.
          o Early growth of hair near the vagina or around the penis (pubic hair).
          o Erections or acting out sexual urges (sex drive).
      - Behavior problems, including acting aggressively or behaving in an angry or violent way.

•     Signs and symptoms in a woman who has come in direct contact with Vitality T Spray may include:
      -Changes in body hair.
      - An abnormal increase in pimples (acne).

​

•    To lower the risk of transfer of Vitality T Spray from your body to others, you should follow these important instructions:
      - Apply to clean, dry skin on the inner arm only, as directed by your healthcare provider.
      - Avoid areas that may come into contact with others (e.g., hands or neck).
      - Prevent women and children from touching application sites until the spray is dry.
      - Wash your hands immediately after application.
      - Keep out of reach of children.
      - After the spray 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 to have skin-to-skin contact with another person, first wash the application area well with soap and water.
      - Store in a cool, dry place away from direct sunlight.

•    Stop using Vitality T Spray and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have happened through accidental touching of the area where you have applied Vitality T Spray.

​

•    Do not use Vitality T Spray if you: 
      - Have Breast or Prostate Cancer: Testosterone therapy is contraindicated in men with these conditions.
      - Have Allergies: Do not use if you are allergic to any components of the spray.
      - Are Pregnant or Breastfeeding Women: Exposure to testosterone can cause harm to an unborn or breastfeeding baby. Women who are pregnant or may  become pregnant should avoid contact with the spray.

•    Before using Vitality T Spray, tell your healthcare provider about all of your medical conditions, including if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; or 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. Especially tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), or corticosteroids.

​

•    Testosterone can cause serious side effects, including:

      - If you already have an enlargement of your prostate gland, your signs and symptoms can get worse while using Vitality T Spray (including changes in urination).

     - 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.

     - In large doses, Vitality T spray may lower your sperm count.

     - Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease.

     - Enlarged or painful breasts.

      - Having problems breathing while you sleep (sleep apnea).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made by a healthcare provider considering the unique characteristics of the patient. This site is intended for US residents only. Use of and access to this site are subject to the Terms of Use and Privacy Statement.