Rx Hair Loss Spray + Ketoconazole + Biotin

Important safety information

Rx Hair Loss Spray + Ketoconazole + Biotin is intended for use by individuals assigned male at birth (including cisgender men and transgender women) who are not pregnant, breastfeeding, or able to become pregnant

Read this patient information before you start using this medication and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Rx Hair Loss Spray + Ketoconazole + Biotin is a prescription medication used for the treatment of male pattern hair loss (androgenetic alopecia). It is a treatment alternative to oral finasteride that has been shown in research studies to be safe and effective. Unlike oral finasteride, Rx Hair Loss Spray + Ketoconazole + Biotin is a compounded product and has not been approved by the FDA. It is only available if prescribed after an online consultation with a medical provider through the Hims platform. The use of topical finasteride to treat hair loss has not been as comprehensively studied as oral finasteride. Research has shown that serum DHT levels decrease while using topical finasteride, and there were very limited reports of systemic side effects (e.g., sexual dysfunction) typically associated with oral finasteride.

Do not use other topical finasteride or minoxidil products while you are using the Topical Rx Hair Loss Finasteride 0.3% Minoxidil 7% Ketoconazole 2.2% Biotin 0.2% Spray.

Do not allow individuals who are pregnant or breastfeeding, individuals who have the potential to become pregnant, or children handle this medication. Do not allow any of these individuals to come into contact with the treatment site (your scalp) after the medication has been applied. If they do, they should immediately clean the site of contact on their skin with soap and water.

What should I tell my healthcare provider before using Rx Hair Loss Spray + Ketoconazole + Biotin?

• If you are pregnant, planning to become pregnant, or are breastfeeding

• Rx Hair Loss Spray + Ketoconazole + Biotin should not be used or handled by individuals who are pregnant or breastfeeding, individuals who have the potential to become pregnant, or individuals under the age of 18.

• If you have any other medical conditions, including problems with your prostate or liver

• If you have ever had a hypersensitivity or allergic reaction to topical minoxidil, topical finasteride + minoxidil, or topical ketoconazole

• All of the medications that you are currently taking, including prescription and nonprescription medications, vitamins, and herbal supplements.

• Know the medications you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medication.

Who should not use Rx Hair Loss Spray + Ketoconazole + Biotin? Do not use Rx Hair Loss Spray + Ketoconazole + Biotin if you:

• are currently taking oral finasteride for hair loss or for treatment of an enlarged prostate (Propecia®, Proscar®). Oral finasteride and Rx Hair Loss Spray + Ketoconazole + Biotin cannot be used at the same time

• are currently taking other medications in the same class as finasteride (5-alpha reductase inhibitors: dutasteride, Avodart®, Jalyn®)

• are pregnant, trying to get pregnant, or may become pregnant due to the possibility of absorption of finasteride and the subsequent potential risk to a male fetus

• are breastfeeding

• are allergic to any of the ingredients of Rx Hair Loss Spray + - Ketoconazole + Biotin

• have chronic liver disease

• have a history of estrogen sensitive cancers such as breast, uterine, and ovarian in the past five years

• have a history of prostate cancer

• are younger than 18 years of age

What are the possible side effects of Rx Hair Loss Spray + Ketoconazole + Biotin? The most common side effects of Rx Hair Loss Spray + Ketoconazole + Biotin typically occur at the site of medication application (scalp). These side effects include:

• Itching

• Redness

• Irritation

• Burning sensation

• Contact dermatitis

• Dry, & flaky scalp

If you develop any of the following side effects, please stop using this topical medication and contact your healthcare provider right away:

• Chest pain

• Rapid heart beat

• Faintness or dizziness

• Sudden & unexplained weight gain

• Swelling of hands or feet

• Breast tenderness/enlargement

• Unwanted facial hair growth

• Sexual dysfunction (e.g., low libido, erectile dysfunction, decreased volume of ejaculate)

• Symptoms of depression

• Severe scalp irritation These are not all of the possible side effects of Rx Hair Loss Spray + Ketoconazole + Biotin. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA by visiting www.fda.gov/medwatch or by phone at 1-800-FDA-1088.

How do I use the Rx Hair Loss Spray + Ketoconazole + Biotin?

• Use this medication exactly as your healthcare provider tells you to use it.

• Do not use this medication more than once a day as it will not improve results and can increase the risk of side effects.

• Wash your hands with soap immediately after applying this medication to your scalp.

What should I do if this medication gets on my face? There is the potential for hair growth to occur on any skin that this medication comes into contact with after repeated use. For this reason, only apply the topical finasteride + minoxidil spray to the scalp, and carefully blot any excess to avoid it running onto your face. If it does get on your face, clean off the medication with gentle soap and water.

How should I store the Rx Hair Loss Spray + Ketoconazole + Biotin?

• Store this medication at room temperature between 59˚F to 86˚F (15˚C to 30˚C).

• Keep this medication and all other medications out of the reach of children.

• Individuals who are pregnant or breastfeeding, individuals under the age of 18 should not handle this medication

• Discard any unneeded medication

General information about the safe and effective use of the Rx Hair Loss Spray + Ketoconazole + Biotin: Do not use this medication for a condition for which it was not prescribed. Do not give this medication to other people, even if they have the same symptoms you have. It may harm them. Minoxidil is suspected to be toxic to cats and dogs. Please do not allow cats, dogs, or other pets to ingest this medication or to come into contact with the treatment site after the medication has been applied. If these occur, consult your pet's veterinarian.