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OptiMist 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 OptiMist T Spray is safe or effective to treat men and women who have low testosterone due to aging.

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

OptiMist 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.

OptiMist T Spray is not meant for use in women.

Secondary Exposure to Testosterone- Women and children should avoid contact with any unwashed or unclothed area where OptiMist T Spray has been applied, particularly just after application when the skin is still wet. Once dry, the risk is believed to be minimal. 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 gels and creams by touching areas where men have used other topical testosterone products.

Signs and symptoms of early puberty in a child who has come in direct contact with topical testosterone preparations 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, including acting aggressively or behaving in an angry or violent way.
• Signs and symptoms of early puberty in a child who has come in direct contact with topical testosterone preparations may include:
  • Changes in body hair.
  • An abnormal increase in pimples (acne).

To lower the risk of transfer of OptiMist T Spray from your body to others, you should follow these important instructions:

• Apply to clean, dry skin on the inner arm or thigh 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 OptiMist 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 OptiMist T Spray.

Do not use OptiMist 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 OptiMist T Spray, tell your healthcare provider about all of your medical conditions, including if you have breast cancer, prostate cancer, urinary problems due to an 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 OptiMist T Spray (including changes in urination). Do not use without consulting your physician.
• In large doses, Testosterone hormone replacement therapies may lower your sperm count.
• 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.