Compounded Minoxidil 5% Scalp Spray

With finasteride or tretinoin when prescribed

Important prescription and FDA information

This is a compounded prescription medication. Compounded medications are not FDA-approved. FDA does not evaluate their safety, effectiveness, or quality before they are marketed. A clinician should determine whether a compounded medication is appropriate for your individual medical needs and discuss available FDA-approved alternatives. FDA compounding information

FDA-approved minoxidil products are available for female pattern hair loss, but their approval does not extend to this compounded spray or its combinations. There is no FDA-approved topical finasteride product, and tretinoin is not FDA-approved to treat hair loss. Women’s minoxidil labeling, FDA topical finasteride alert, Tretinoin drug information

Your prescription label identifies your ingredients and strengths. Use only the formulation prescribed to you. Results vary, and hair regrowth is not guaranteed.

How the ingredients work

• Minoxidil supports hair growth and helps maintain hair thickness. Its complete mechanism of action is not fully understood. Continued treatment is generally needed to maintain its benefits. American Academy of Dermatology

• Finasteride, if included, inhibits an enzyme called 5-alpha-reductase, reducing the conversion of testosterone to dihydrotestosterone, or DHT. Its use for female hair loss is off-label. Evidence for topical treatment in women is limited and includes a small study in postmenopausal women using a different formulation. Finasteride prescribing information, Clinical study

• Tretinoin, if included, is a retinoid that changes skin-cell turnover and can increase minoxidil absorption through the skin. Increased absorption does not establish better results or greater safety for your particular formulation. Absorption study

Who should avoid treatment or obtain further evaluation?

Do not use this product:

• If you are pregnant, trying to become pregnant, or breastfeeding.

• If you are allergic to any active ingredient or ingredient in the spray base.

• On a scalp that is infected, inflamed, painful, sunburned, broken, or significantly irritated.

• If you are under 18 years old.

Sudden, patchy, unexplained, or childbirth-related hair loss requires medical evaluation before treatment. These patterns can have causes that need a different approach. Women’s minoxidil labeling, Pregnancy and breastfeeding precautions

Before starting, tell your clinician about heart disease, low blood pressure, fainting, kidney or liver disease, scalp conditions, and all medications and supplements you use. Specifically disclose other hair-loss medicines, blood-pressure medicines, and products applied to your scalp. Minoxidil drug information

Possible side effects

Minoxidil can cause scalp itching, dryness, redness, scaling, or irritation; unwanted facial hair; and changes in hair texture or color. Temporary increased shedding can occur early in treatment. Contact your clinician if shedding is severe or persistent, or if you develop scalp irritation or unwanted hair growth. American Academy of Dermatology, Minoxidil labeling

Stop treatment and obtain prompt medical attention for chest pain, a rapid heartbeat, fainting, significant dizziness, sudden unexplained weight gain, or swelling of your hands or feet. Seek emergency care for severe chest pain, difficulty breathing, or swelling of your face, lips, tongue, or throat. Minoxidil drug information, Tretinoin safety information

Additional warnings if your prescription contains finasteride

Topical finasteride can enter the bloodstream. FDA has received reports of sexual dysfunction, decreased libido, depression, anxiety, suicidal thoughts, fatigue, insomnia, and difficulty thinking with compounded topical finasteride. Some reports describe symptoms continuing after discontinuation. These reports do not establish frequency or prove causation; risks specifically in women remain insufficiently characterized.

Contact your clinician promptly for new mood or sexual symptoms. Seek immediate medical help for suicidal thoughts.

Finasteride can harm a developing male fetus. Prevent pregnant people or people who could become pregnant from contacting the medication, treated scalp, spills, or contaminated surfaces. If accidental skin exposure occurs, wash the area thoroughly and contact a healthcare professional. FDA topical finasteride safety alert

If you can become pregnant, discuss eligibility, effective contraception, and pregnancy testing with your prescriber before treatment. Do not start without a clinician-established pregnancy-prevention plan. Stop treatment and contact your clinician immediately if pregnancy occurs or is suspected. American Academy of Dermatology

Additional warnings if your prescription contains tretinoin

Tretinoin can cause burning, stinging, redness, peeling, and increased sensitivity to sunlight. Avoid tanning beds and protect exposed treated areas with a hat and sunscreen. Stop treatment and contact your clinician for severe irritation, blistering, or painful skin.

Do not add other retinoids, exfoliating acids, benzoyl peroxide, or irritating scalp treatments without your clinician’s approval. Tretinoin drug information

Tretinoin can increase minoxidil absorption. The extent depends on the formulation and skin condition; findings from other products cannot establish the absorption or side-effect rate of your compounded spray. Absorption study

Safe use and storage

Apply only to the dry scalp as prescribed. Avoid your face, eyes, mouth, and other body areas, and avoid inhaling the spray. Wash your hands after application. If the spray enters your eyes, rinse thoroughly with water.

Do not apply extra medication to accelerate results or make up for a missed application. Do not add other scalp medicines or apply to skin disrupted by procedures such as microneedling without prescriber guidance. Follow the pharmacy’s instructions for drying, washing, and preventing transfer to other people. Minoxidil drug information

Keep the medication tightly closed and follow its storage instructions and beyond-use date. If the formulation contains alcohol or another flammable solvent, follow the pharmacy’s fire and heat precautions. Do not share your prescription.

Keep away from children and pets. Minoxidil can be highly toxic to cats and dogs. Prevent pets from licking treated skin or contacting spills, medication residue, or contaminated bedding. Seek immediate veterinary care after possible exposure. American Academy of Dermatology pet warning

This information does not include every possible risk or interaction. Contact your prescriber or pharmacist with questions. Suspected adverse reactions or product-quality problems may also be reported to FDA MedWatch.