Important safety information
The Compounded 3-in-1 Hair Loss Solution (Lemonaid Headstrong Spray) is prescribed for the treatment of male pattern hair loss. Headstrong Spray is legally permitted under federal law but has not been FDA-approved and does not undergo FDA review for safety, effectiveness, or manufacturing standards. See the safety information for finasteride, minoxidil, and tretinoin.
Important Safety Information for Finasteride
Who Should Avoid Using Finasteride
Do not use the Headstrong Spray if you have an allergy to finasteride, minoxidil, tretinoin, ethyl alcohol, or propylene glycol.
People who could become pregnant should not touch or handle Headstrong Spray or share a pillowcase, hairbrush, or other item that may have come into contact with the solution.
Do not use the Headstrong Spray on damaged skin including sunburned, cut, scraped, infected, red, swollen, or irritated skin.
Use of the Headstrong Spray
Headstrong Spray is prescribed for male pattern hair loss and is for use on the scalp only. Daily use for over 4 months may be needed to see the full effect of the medication.
Before using Finasteride, tell your healthcare provider about
All of your medical conditions. Provide your complete medical history, particularly if you have a history of diminished urinary flow, liver disease, or prostate cancer.
All medications you are taking. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take. Include any other topical medications.
Finasteride may cause serious side effects, including:
- Severe skin reactions. Tell your healthcare provider if you develop a skin reaction that is severe with extreme blistering, swelling, burning, peeling, or other symptoms.
- Breast enlargement or changes. Tell your healthcare provider if you develop enlarged breasts, a lump in the breast, breast pain or soreness, or nipple discharge.
- Serious allergic reactions. Stop using the Headstrong Spray immediately and seek medical assistance if you experience any of the following symptoms: swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.
Common side effects of topical Finasteride may include irritation, itching, dryness, or other changes at the application area of the scalp. Finasteride may cause effects of feeling dizzy, tired, or weak. Changes or a decrease in desire or ability to engage in intercourse may occur. This could continue after the medication is stopped. Stop finasteride use and seek medical attention if the sexual effects contribute to increased anxiety, depression, or thoughts of suicide.
If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Important Safety Information for Minoxidil
Who Should Avoid Using Minoxidil
Do not use Headstrong Spray if you have an allergy to minoxidil, finasteride, tretinoin, ethyl alcohol, or propylene glycol.
People who could become pregnant should not touch or handle the Headstrong Spray or share a pillowcase, hairbrush, or other item that may have come into contact with the solution.
Do not use Headstrong Spray on damaged skin including sunburned, cut, scraped, infected, red, swollen, or irritated skin.
Use of Headstrong Spray
Headstrong Spray is prescribed for male pattern hair loss and is for use on the scalp only. Daily use for over 4 months may be needed to see the full effect of the medication.
Before using Minoxidil, tell your healthcare provider about
All of your medical conditions. Provide your complete medical history, particularly if you have a history of heart failure or recent heart attack, kidney impairment, pheochromocytoma, or compromised circulation.
All medications you are taking. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take. Include any other topical medications.
Minoxidil may cause serious side effects, including:
- Severe skin reactions. Tell your healthcare provider if you develop a skin reaction that is severe with extreme blistering, swelling, burning, peeling, or other symptoms.
- Serious allergic reactions. Stop using Headstrong Spray immediately and seek medical assistance if you experience any of the following symptoms: swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.
- Chest pain, pressure, or a fast heartbeat. Stop Headstrong Spray use and seek medical attention for these symptoms.
- Dizziness or fainting. Minoxidil may cause low blood pressure that happens when standing after sitting or lying down.
- Rapid weight gain. Discontinue use and contact your healthcare provider if sudden unexplained weight gain or swelling in the hands or feet occurs.
- Unwanted facial hair growth.
Common side effects of topical Minoxidil may include irritation, itching, or dryness at the application area of the scalp or changes in hair color or texture.
If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Important Safety Information for Tretinoin
Who Should Avoid Using Tretinoin
Do not use Headstrong Spray if you have an allergy to tretinoin, finasteride, minoxidil, ethyl alcohol, or propylene glycol.
People who could become pregnant should not touch or handle Headstrong Spray or share a pillowcase, hairbrush, or other item that may have come into contact with the solution.
Do not use Headstrong Spray on damaged skin including sunburned, cut, scraped, infected, red, swollen, or irritated skin.
Use of Headstrong Spray
Headstrong Spray is prescribed for male pattern hair loss and is for use on the scalp only. Daily use for over 4 months may be needed to see the full effect of the medication.
Before using Tretinoin, tell your healthcare provider about
All of your medical conditions. Provide your complete medical history, particularly if you have a history of eczema, sensitivity to sunlight or other conditions that may increase sensitivity to sunlight, or a family history of skin cancer.
All medications you are taking. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take. Include any other topical medications.
Tretinoin may cause serious side effects, including:
- Severe skin reactions. Tell your healthcare provider if you develop a skin reaction that is severe with extreme blistering, swelling, burning, peeling, or other symptoms.
- Serious allergic reactions. Stop Headstrong Spray immediately and seek medical assistance if you experience any of the following symptoms: swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.
Common side effects of Tretinoin may include feelings of burning, stinging, itching, or warmth at the application area. Other skin reactions may include dryness, redness, swelling, blistering, peeling, or a change in skin color. Tretinoin increases sensitivity to sunlight which may increase the possibility of sunburn on the treated areas. Measures to protect the scalp from the sun are recommended including using a hat and sunscreen.
If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Important Safety Information for Minoxidil oral tablets
Warning: Heart Related Side Effects
Minoxidil can cause severe heart related side effects including sharp chest pain, shortness of breath, rapid heart rate, low blood pressure, and dizziness. Studies in animals have shown that minoxidil can lead to lesions of the heart or other adverse heart effects.
Who Should Avoid Using Minoxidil
Do not use minoxidil if you have an allergy to minoxidil.
Do not use minoxidil if you have pheochromocytoma, an adrenal gland tumor.
Use of Minoxidil
Minoxidil is prescribed for male pattern hair loss.
Before using Minoxidil, tell your healthcare provider about
All of your medical conditions. Provide your complete medical history, particularly if you have a history of kidney impairment or dialysis, congestive heart failure, pericardial effusion, pericardial tamponade, pericarditis, angina, recent heart attack, pulmonary hypertension associated with mitral stenosis, compromised circulation, tachycardia or arrhythmia, or hypotension.
All medications you are taking. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take.
Minoxidil may cause serious side effects, including:
- Serious allergic reactions. Stop minoxidil use immediately and seek medical assistance if you experience any of the following symptoms: swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.
- Chest pain, pressure, or a fast heartbeat. Stop minoxidil use and seek medical attention for these symptoms.
- Dizziness or fainting. Minoxidil may cause low blood pressure that happens when standing after sitting or lying down.
- Rapid weight gain. Discontinue use and contact your healthcare provider if sudden unexplained weight gain or swelling in the hands or feet occurs.
- Severe heartburn. Contact your healthcare provider if you experience heartburn that is severe or will not go away.
- Hearing or vision changes.
Common side effects of Minoxidil may include upset stomach or vomiting and hair growth in undesirable locations on the body.
Consult the complete prescribing information for more details about the safety of minoxidil. If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Important Safety Information for Finasteride oral tablets
Who Should Avoid Using Finasteride
Do not use finasteride if you have an allergy to finasteride.
People who could become pregnant should not touch or handle crushed or broken tablets.
FDA-Approved Use of Finasteride
Finasteride is FDA-approved for the treatment of male pattern hair loss. Daily use for over 3 months may be needed to see the full effect of the medication.
Before using Finasteride, tell your healthcare provider about
All of your medical conditions. Provide your complete medical history, particularly if you have a history of diminished urinary flow, liver disease, or prostate cancer.
All medications you are taking. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take.
Finasteride may cause serious side effects, including:
- Breast enlargement or changes. Tell your healthcare provider if you develop enlarged breasts, a lump in the breast, breast pain or soreness, or nipple discharge.
- Serious allergic reactions. Stop finasteride use immediately and seek medical assistance if you experience any of the following symptoms: swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.
Common side effects of Finasteride may include feeling dizzy, tired, or weak. Changes or a decrease in desire or ability to engage in intercourse may occur. This could continue after the medication is stopped. Stop finasteride use and seek medical attention if the sexual effects contribute to increased anxiety, depression, or thoughts of suicide.
Consult the complete prescribing information for more details about the safety of finasteride. If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.