Important Safety Information

Warning: Mild scalp irritation

What is the FDA-approved use of Hair Regrowth medications?

Ingredients used in hair regrowth, such as finasteride and minoxidil, are FDA-approved for the treatment of androgenetic alopecia (pattern hair loss). Finasteride helps reduce DHT levels to slow shedding, while minoxidil supports follicle activity and hair density.

Other components in the program—such as biotin, ketoconazole, or azelaic acid—may be used as part of a wellness-guided hair restoration plan, depending on patient needs. Each medication is evaluated individually for safety, quality, and effectiveness before receiving approval for specific medical indications.

Limitations of Use

Hair regrowth programs are widely used for androgenetic alopecia, thinning, and progressive shedding, but certain wellness-focused goals such as “fast regrowth,” “aesthetic enhancement,” or “anti-aging hair benefits” have limited long-term clinical research.

While finasteride-minoxidil combinations can support improved density and reduced shedding, results vary and work best with consistent use, healthy routines, and ongoing provider supervision.

Who Should Avoid the Hair Regrowth Protocol?

Hair regrowth medications are not appropriate for everyone. Individuals should avoid treatment if they are:

• • Pregnant, breastfeeding, or planning pregnancy
  • Diagnosed with active cancer
  • Managing uncontrolled medical conditions
  • Living with severe kidney or liver issues
  • Allergic or sensitive to any ingredient (finasteride, minoxidil, ketoconazole, azelaic acid, biotin)

Anyone taking medications that may interact with these treatments should consult a licensed clinician before starting therapy.

Finasteride specifically should not be handled by pregnant individuals due to the risk of absorption.

How Is the Hair Regrowth Protocol Administered?

Treatment is delivered through a combination of oral capsules and topical scalp solutions, based on your selected plan:

• • Oral Hair Loss Treatment: DHT blocker for hair loss capsule
    Biotin / Finasteride / Minoxidil — daily capsule, 5 / 1.25 / 5 mg
  • Oral + Advanced Topical Combo:
    Capsule + Hair Restore MFK Scalp Solution (Minoxidil 5% / Finasteride 0.3% / Ketoconazole 2%)
  • Oral + Ultra Strength Topical:
    Capsule + Hair Restore Ultra Solution (Minoxidil 5% / Azelaic Acid 12.5% / Finasteride 0.1% / Ketoconazole 2%)

A professional determines the appropriate formula, dosage, and routine based on your pattern of hair loss, medical history, and goals.

Common Side Effects of the Hair Regrowth Protocol

Side effects are generally mild unless influenced by allergies or medical conditions. These may include:

• • Scalp irritation
  • Scalp itching or redness
  • Dryness or flaking
  • Temporary increased shedding
  • Headache
  • Dizziness
  • Unwanted facial/body hair
  • Mild sexual side effects (rare)

What are the most serious side effects a caregiver or patient should watch for?

Most patients tolerate treatment well, and reactions, when they occur, are mild and temporary.
Rarely, individuals may experience:

• • Sexual side effects (possible with finasteride; uncommon but documented)
  • Dizziness (can occur with minoxidil, especially topical overuse)
  • Unwanted facial or body hair (from minoxidil spreading beyond target areas)

Severe reactions are very uncommon and usually linked to allergies, improper application, or underlying medical conditions. A licensed provider should monitor all regimens to ensure safe, comfortable, and effective use.

Prime Pulse Rx includes regular virtual follow-ups to monitor your progress and adjust dosage or product formulation when needed. These visits are essential to ensure your continued safety and the effectiveness of your treatment plan.

Note:  All Prime Pulse Rx compounded products are prepared by licensed pharmacies and prescribed under medical supervision. These formulations are prescribed based on evidence-supported clinical judgment. Individual results may vary.