Important Safety Information: Minoxidil, Finasteride, Fluocinolone, Tretinoin, Caffeine, Azelaic Acid | Compounded Topical

What is this?

This Important Safety Information summarizes key warnings and precautions for Minoxidil / Finasteride / Fluocinolone / Tretinoin / Caffeine / Azelaic Acid, a compounded topical formulation used to support scalp health and hair regrowth. This solution combines a vasodilator, 5-alpha reductase inhibitor, topical corticosteroid, retinoid, stimulant, and anti-inflammatory/keratolytic agent to address multiple contributors to hair thinning.

This compounded topical formulation is not reviewed or approved by the U.S. Food and Drug Administration for safety or efficacy and should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions. 

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including rash, hives, swelling of the face, lips, or tongue

• Severe scalp irritation, blistering, or chemical burns

• Systemic absorption effects, including dizziness, rapid heartbeat, or low blood pressure (minoxidil)

• Hormonal effects, including sexual side effects due to finasteride exposure

• Skin thinning or long-term steroid-related changes from fluocinolone

• Increased skin sensitivity, peeling, or photosensitivity from tretinoin

Compounded topical medications may carry formulation or stability risks due to limited FDA oversight.

Who Should NOT Use This Medication

Do not use this medication if you:

• Have a known allergy to any ingredient in the formulation

• Are pregnant or may become pregnant, particularly due to finasteride risk

• Are breastfeeding without provider approval

• Have untreated scalp infections or open wounds in the treatment area

• Have a history of hypersensitivity to topical retinoids or corticosteroids

Before Using This Medication, Tell Your Healthcare Provider if You:

• Have heart disease, low blood pressure, or cardiovascular conditions

• Have a history of hormone-sensitive conditions

• Are pregnant, planning pregnancy, or breastfeeding

• Are using other topical scalp treatments or systemic hair loss medications

• Take prescription, over-the-counter, or herbal medications

• Experience excessive scalp irritation or sensitivity

Possible Side Effects

Common (mild to moderate):

• Scalp redness or irritation

• Dryness, peeling, or flaking

• Mild burning or itching at the application site

• Temporary increased hair shedding during early treatment

Serious (seek medical care immediately):

• Swelling of the face, lips, tongue, or throat

• Severe rash or blistering

• Chest pain, dizziness, fainting, or rapid heartbeat

• Persistent or severe hormonal side effects

• Severe skin thinning or discoloration

While Using This Medication

Tell your healthcare provider immediately if you:

• Develop severe scalp irritation or blistering

• Experience dizziness, fainting, or heart palpitations

• Notice new or worsening sexual side effects

• Develop symptoms of an allergic reaction

• See no improvement or worsening symptoms after an appropriate treatment period

Pregnancy and Fertility

Finasteride may cause harm to a developing male fetus. This medication should not be used during pregnancy. Women who are pregnant or may become pregnant should avoid contact with this medication unless specifically instructed by a healthcare provider.

Overdose

Excessive topical use or accidental ingestion may increase the risk of systemic side effects such as dizziness, low blood pressure, or hormonal changes. If overdose or accidental ingestion is suspected, seek emergency medical attention or contact Poison Control immediately.

Missed Dosage

If you miss a scheduled dose:

• Apply it when you remember unless it is close to the next scheduled application

• Do not double the next dose

• Resume your regular schedule as directed

Storage

• Store at room temperature unless otherwise directed on the pharmacy label

• Keep tightly closed

• Protect from excessive heat and light

• Keep out of reach of children and pets

Medication Disposal

This formulation may contain hazardous components. Dispose of unused or expired medication according to local hazardous waste regulations. Do not pour down drains or flush unless instructed.

Provider Oversight and Order Review

This compounded medication requires review and oversight by licensed Superior Health and Wellness providers. Dosing instructions and duration of therapy must be discussed directly with your provider to ensure safety and clinical appropriateness.

Telemedicine Disclosure

This prescription may be issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about this compounded topical formulation and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy.