Important Safety Information for Hair Solution Rx
Important safety information you should know about the active ingredients in Hair Solution Rx
Hair Solution Rx is a compounded prescription drug. Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review:
Important Safety Information for Topical Finasteride
What is topical finasteride used for?
Your Ro-affiliated provider may recommend the use of Hair Solution Rx, a compounded prescription drug containing finasteride, minoxidil, and tretinoin, as a topical treatment for hair loss.
The compounded treatment is for men only, and should not be used or handled by women or children
Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review. Who should not use Hair Solution Rx? Do not use if:
You are a woman. The compounded treatment is for men only, and should not be used or handled by women, especially if they are pregnant or trying to become pregnant. In animal studies, finasteride caused abnormal development of genitalia in male fetuses.
Your scalp is red, inflamed, infected, irritated, or painful
You have a known allergic reaction to finasteride, minoxidil, or tretinoin.
How should I use the topical treatment?
Step 1: Spray it
Use the spray to cover the areas on your scalp that experience hair loss, which may include the crown of the head and/or each side of a receding hairline. Do not exceed 4 sprays total. When you spray, make sure you press the sprayer firmly, all the way down.
Step 2: Massage it
Once you’ve sprayed on the solution, massage it into the balding areas of the scalp. Tip your head back slightly to prevent any solution from running down your forehead.
Step 3: Remove any excess medication and wash your hands
Wipe away any excess medication that may have run onto your face or down your head, and wash your hands well after you finish.
Step 4: Let it dry
Let the solution dry so it can absorb properly into the scalp. You may apply the solution to wet or dry hair, but allow it to dry completely before applying other products. If you apply the solution in the morning, try not to get your hair wet before the end of the day. If you apply at night, you can wash your hair the next morning.
Avoid getting the medication in your eyes. If this occurs, rinse your eyes with large amounts of cool water. Wash your hands thoroughly after each use.
Important: Hair Solution Rx is not safe for women who are pregnant or trying to become pregnant, so it is recommended that they do not touch or handle the bottle, and as an extra precaution, that they do not share a pillow or any other surfaces.
What should I tell my Ro-affiliated provider before using topical finasteride?
It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have or have a past history of:
Erectile dysfunction
Depression
Thoughts of self-harm
Prostate cancer
Breast cancer
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I or a caregiver should monitor for when taking finasteride?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
Effects on Prostate-Specific Antigen (PSA) levels: Finasteride can decrease PSA levels. When checking PSA levels, let your provider know that you are taking finasteride for an accurate interpretation of the results. A PSA test is used as a screening tool for prostate cancer.
Increased Risk of High-Grade Prostate Cancer with 5α-Reductase Inhibitors: In two studies studying 5α-reductase inhibitors for the prevention of prostate cancer, an increase in high-grade prostate cancer was found.
What are the most common side effects of topical finasteride?
Due to topical application of the medication, skin-related side effects may be experienced at a higher rate.
Scalp irritation, including burning, itching, redness, or bumps
Scalp flaking
A temporary shedding of hair in the initial weeks of treatment
Changes in hair texture
You may experience mild side effects—including irritation, itching, a burning sensation, and dryness— on your scalp, especially in the first few weeks of using the medication. To help with these side effects, you may want to use your spray three times a week at first, then gradually build up to daily use as your skin adjusts. Use good sun protection for exposed areas of your scalp, since the tretinoin in this spray can make your scalp more sensitive to the sun.
Systemic side effects of finasteride may still occur and it is important to be aware of them.
These side effects include:
Decreased libido
Erectile dysfunction
Ejaculation disorder
Mood changes
Decreased sperm count
Testicular pain
Brain fog
Insomnia
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the full Consumer Medical Information for complete safety information.
Important Safety Information for Topical Minoxidil
What is topical minoxidil used for? Your Ro-affiliated provider may recommend the use ofHair Solution Rx, a compounded prescription drug containing finasteride, minoxidil, and tretinoin, as a topical treatment for hair loss.
The compounded treatment is for men only, and should not be used or handled by women or children.
Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review.
Who should not use Hair Solution Rx?
Do not use if:
You are a woman. The compounded treatment is for men only, and should not be used or handled by women, especially if they are pregnant or trying to become pregnant. In animal studies, finasteride caused abnormal development of genitalia in male fetuses.
Your scalp is red, inflamed, infected, irritated, or painful
You have a known allergic reaction to finasteride, minoxidil, or tretinoin.
How should I use the topical treatment?
Step 1: Spray it
Use the spray to cover the areas on your scalp that experience hair loss, which may include the crown of the head and/or each side of a receding hairline. Do not exceed 4 sprays total. When you spray, make sure you press the sprayer firmly, all the way down.
Step 2: Massage it
Once you’ve sprayed on the solution, massage it into the balding areas of the scalp. Tip your head back slightly to prevent any solution from running down your forehead.
Step 3: Remove any excess medication and wash your hands
Wipe away any excess medication that may have run onto your face or down your head, and wash your hands well after you finish.
Step 4: Let it dry
Let the solution dry so it can absorb properly into the scalp. You may apply the solution to wet or dry hair, but allow it to dry completely before applying other products. If you apply the solution in the morning, try not to get your hair wet before the end of the day. If you apply at night, you can wash your hair the next morning.
Avoid getting the medication in your eyes. If this occurs, rinse your eyes with large amounts of cool water. Wash your hands thoroughly after each use.
Important: Hair Solution Rx is not safe for women who are pregnant or trying to become pregnant, so it is recommended that they do not touch or handle the bottle, and as an extra precaution, that they do not share a pillow or any other surfaces.
What should I tell my Ro-affiliated provider before using topical minoxidil?
It’s important to tell your Ro-affiliated provider all of the topical as well as oral medications you are currently using, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements, even if you think they are unrelated to the condition being treated. Let your provider know if you are using or planning to use any other topical scalp treatments.
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a history of heart disease.
What are the most serious side effects that I should monitor for when using topical minoxidil?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects are rare, but may occur with topical minoxidil. Tell your provider if:
Chest pain, rapid heartbeat, faintness, or dizziness occurs
Sudden, unexplained weight gain occurs
Your hands or feet swell
Scalp irritation or redness occurs
Unwanted facial hair growth occurs
Inflammatory reaction with blistering occurs
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most common side effects of topical minoxidil?
You may experience mild side effects—including irritation, itching, a burning sensation, and dryness— on your scalp, especially in the first few weeks of using the medication. To help with these side effects, you may want to use your spray three times a week at first, then gradually build up to daily use as your skin adjusts. Use good sun protection for exposed areas of your scalp, since the tretinoin in this spray can make your scalp more sensitive to the sun.
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the full Consumer Medical Information for complete safety information
Important Safety Information for Tretinoin
What is tretinoin used for?
Your Ro-affiliated provider may recommend the use of Hair Solution Rx, a compounded prescription drug containing finasteride, minoxidil, and tretinoin, as a topical treatment for hair loss.
The compounded treatment is for men only, and should not be used or handled by women or children.
Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review.
Who should not use Hair Solution Rx?
Do not use if:
You are a woman. The compounded treatment is for men only, and should not be used or handled by women, especially if they are pregnant or trying to become pregnant. In animal studies, finasteride caused abnormal development of genitalia in male fetuses.
Your scalp is red, inflamed, infected, irritated, or painful
You have a known allergic reaction to finasteride, minoxidil, or tretinoin.
How should I use the topical treatment?
Step 1: Spray it
Use the spray to cover the areas on your scalp that experience hair loss, which may include the crown of the head and/or each side of a receding hairline. Do not exceed 4 sprays total. When you spray, make sure you press the sprayer firmly, all the way down.
Step 2: Massage it
Once you’ve sprayed on the solution, massage it into the balding areas of the scalp. Tip your head back slightly to prevent any solution from running down your forehead.
Step 3: Remove any excess medication and wash your hands
Wipe away any excess medication that may have run onto your face or down your head, and wash your hands well after you finish.
Step 4: Let it dry
Let the solution dry so it can absorb properly into the scalp. You may apply the solution to wet or dry hair, but allow it to dry completely before applying other products. If you apply the solution in the morning, try not to get your hair wet before the end of the day. If you apply at night, you can wash your hair the next morning.
Avoid getting the medication in your eyes. If this occurs, rinse your eyes with large amounts of cool water. Wash your hands thoroughly after each use.
Important: Hair Solution Rx is not safe for women who are pregnant or trying to become pregnant, so it is recommended that they do not touch or handle the bottle, and as an extra precaution, that they do not share a pillow or any other surfaces.
What should I tell my Ro-affiliated provider before using tretinoin?
It’s important to tell your Ro-affiliated provider all of the topical as well as oral medications you are currently using, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Tell your provider if you are using or planning to use any other topical scalp treatments.
Tretinoin can make the skin on your scalp more sensitive to the sun and can cause drying and peeling.
Using tretinoin with other topical drying agents can increase the drying effects of tretinoin.
Some common oral medications that can make your skin more sensitive to the sun, such as certain antibiotics and blood pressure medications, might exacerbate any sun sensitivity resulting from tretinoin use.
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a history of:
Eczema
Sensitivity to the sun or are easily sunburned
Conditions that may increase sensitivity to sunlight. These include systemic lupus erythematosus, cutaneous lupus erythematosus, albinism, and porphyria
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I should monitor for when using tretinoin?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects are rare, but may occur with tretinoin.
Skin discoloration
Inflammatory reaction with blistering
What are the most common side effects of tretinoin?
You may experience mild side effects—including irritation, itching, a burning sensation, and dryness— on your scalp, especially in the first few weeks of using the medication. To help with these side effects, you may want to use your spray three times a week at first, then gradually build up to daily use as your skin adjusts. Use good sun protection for exposed areas of your scalp, since the tretinoin in this spray can make your scalp more sensitive to the sun.
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the full Consumer Medical Information for complete safety information.