Tranexamic Acid 4% | Kojic Acid 1% | Niacinamide 3%

Applied topically to the affected skin once or twice daily as directed by the prescriber. Apply a thin, even layer to clean, dry skin over affected areas (face, hands, or body). Do not apply to eyes or mucous membranes. Allow the product to absorb before applying additional products or sunscreen. Daily broad-spectrum sunscreen (SPF 30+) is essential—UV exposure stimulates the very pathways these agents inhibit, significantly reducing efficacy.

Apply a thin layer to affected areas once or twice daily as prescribed. Reassess clinical response at 12 weeks; if no visible improvement is observed, the prescriber should re-evaluate the treatment plan.

• All dosing instructions are prescriber-determined.
• Maintain consistent daily application and strict sun protection for best outcomes.

• Tranexamic Acid (4%): Inhibits UV-induced activation of the plasminogen/plasmin system in keratinocytes. Plasmin normally releases arachidonic acid and stimulates prostaglandins and α-melanocyte-stimulating hormone (α-MSH), which activate melanocytes to produce melanin. By blocking plasminogen receptor binding, tranexamic acid reduces the release of these paracrine melanogenic stimulators. It also inhibits protease-activated receptor 2 (PAR-2) in keratinocytes, suppressing angiogenesis and reducing dermal vascularity.
• Kojic Acid (1%): A naturally occurring compound produced by Aspergillus and other fungi that chelates the copper ion essential for tyrosinase activity, preventing enzymatic conversion of tyrosine to L-DOPA (the committed step of melanin synthesis). This reduces both eumelanin and pheomelanin production at the melanocyte level.
• Niacinamide (3%): A water-soluble form of vitamin B3 that acts at the melanosome-transfer step—after melanin is synthesized, it must be transferred to surrounding keratinocytes to produce visible pigmentation. Niacinamide inhibits this transfer without inhibiting melanocyte activity itself, resulting in reduced cutaneous pigmentation. Additionally, niacinamide has anti-inflammatory effects (reducing acne and rosacea-related redness), improves epidermal barrier function (increases ceramide synthesis), and provides photo-immunoprotective effects.

This combination is used prescriber-directed for melasma, post-inflammatory hyperpigmentation (PIH), and other forms of dyschromia. The triple combination addresses distinct steps in the pigmentation pathway for potentially synergistic depigmenting effects. Clinical studies of comparable TXA/kojic acid/niacinamide serums have shown 60% improvement in melasma and 81% improvement in PIH at 12 weeks.

Monitoring considerations:

• Assess for contact dermatitis, particularly with kojic acid (sensitization risk, especially >1% concentration)
• Reinforce strict daily sunscreen use (SPF 30+) and sun avoidance to prevent re-pigmentation
• If no improvement at 12 weeks, reassess diagnosis and consider alternative or combination therapies (e.g., tretinoin, hydroquinone)
• Avoid use near eyes; if accidental contact, flush with water

Contraindications:

• Known hypersensitivity to tranexamic acid, kojic acid, niacinamide, or any excipient
• Application to broken, infected, or severely inflamed skin

Warnings & Precautions:

• Kojic acid: may cause contact dermatitis, especially in sensitive skin; discontinue if redness, rash, or itching occurs
• Kojic acid increases UV sensitivity over time—daily sunscreen is mandatory
• Tranexamic acid systemic absorption via topical route is low; however, patients with severe renal insufficiency should use with caution
• Niacinamide: flushing is uncommon at concentrations ≤4%; distinguish from contact sensitivity

Drug Interactions:

• No significant topical drug interactions are established for this combination
• Concurrent use of strong exfoliants (high-concentration acids, retinoids) may increase irritation

Common Side Effects: Mild erythema, dryness, stinging, or peeling at application site; contact dermatitis with kojic acid; increased photosensitivity (kojic acid).

Store at room temperature (15–25°C), away from heat, humidity, and direct sunlight. Do not freeze. Kojic acid is photosensitive and may discolor with prolonged UV exposure; keep container sealed when not in use. Use within the beyond-use date specified by Genesis Compounding.

What skin conditions is this formulation designed to treat?

It is designed for melasma, post-inflammatory hyperpigmentation (PIH), sun spots, and other forms of uneven skin pigmentation. Each ingredient targets a different step in the pigment-production and pigment-transfer pathway.

Why do all three ingredients together work better than one alone?

Tranexamic acid reduces the signal that triggers melanin production; kojic acid blocks the enzyme that makes melanin; and niacinamide prevents finished melanin from being transferred to surrounding skin cells. Together, they inhibit pigmentation at multiple independent steps.

Do I need to wear sunscreen while using this?

Yes—this is essential. UV light activates the same pathways these agents are trying to block. Without daily SPF 30+ broad-spectrum sunscreen, hyperpigmentation will recur or worsen. Kojic acid also increases sun sensitivity.

When will I see results?

Initial improvements in tone and brightness can appear within 2–4 weeks; more significant reductions in melasma and dark spots typically require 8–12 weeks of consistent daily use.

Is this FDA-approved?

This is a 503A compounded preparation by Genesis Compounding. Individual ingredients have established dermatologic use; this specific combination formulation is not FDA-approved as a compounded product.