Acyclovir 6% | Lidocaine 2% | Hydrocortisone 1%

Applied topically to the affected perioral or lip area at the first prodromal symptom of herpes simplex labialis recurrence (tingling, burning, itching).

• Apply a thin layer to the lesion and surrounding skin up to five times daily while awake.
• Do not apply to mucous membranes, inside the mouth, or near the eyes.
• Wash hands before and after application.
• Initiate as early as possible in the prodromal phase for optimal viral and symptomatic control.

Based on established clinical pharmacology for the antiviral and anti-inflammatory components:

• Apply topically five times daily (approximately every 3 waking hours) for up to 5 days.
• Begin treatment at prodromal symptoms for optimal antiviral and anti-inflammatory effect.
• Lidocaine provides additional symptomatic relief throughout the application course.
• Final dosing is prescriber-determined.

• Acyclovir: Selectively phosphorylated by HSV thymidine kinase in infected cells to acyclovir triphosphate, which competitively inhibits viral DNA polymerase and terminates viral DNA chain extension, reducing viral replication without significant impact on uninfected host cells.
• Lidocaine: Binds and reversibly blocks voltage-gated sodium channels in sensory nerve axons at the application site, preventing action potential propagation and producing local analgesia without systemic effects at topical concentrations.
• Hydrocortisone: Binds glucocorticoid receptors in keratinocytes and local immune cells, suppressing NF-κB–mediated transcription of pro-inflammatory cytokines, prostaglandin synthesis, and immune cell chemotaxis, thereby reducing erythema, edema, and tissue ulceration.

The addition of lidocaine to the acyclovir/hydrocortisone combination addresses the symptom burden component of herpes simplex labialis:

• Pain, burning, and tenderness are prominent features of HSL recurrences, particularly at the ulcerative stage.
• Lidocaine 2% provides localized analgesia, improving patient comfort while the antiviral and anti-inflammatory components address the underlying pathology.

Clinical considerations:

• Initiate at first prodromal symptom for maximal antiviral benefit.
• Immunocompromised patients may need systemic antiviral coverage; consult prescriber.
• Lidocaine systemic absorption from this topical area is negligible at 2% when applied correctly; methemoglobinemia risk is extremely low at this concentration with appropriate use.

Contraindications:

• Hypersensitivity to acyclovir, valacyclovir, lidocaine (amide anesthetics), or hydrocortisone.
• Do not apply to eyes, mucous membranes, or intact denuded skin (large raw lesions).

Warnings & Precautions:

• External use only; avoid ocular exposure.
• At 2% lidocaine topically on a small area, systemic absorption is minimal; however, avoid excessive application area or occluded application.
• Prolonged glucocorticoid use on thin facial skin should be avoided; standard 5-day courses minimize risk.
• Monitor for local irritation, contact allergy, or worsening lesion.

Drug Interactions:

• Systemic interactions are negligible given the topical application area and low systemic absorption of all three components at standard doses.

Common Side Effects: Local stinging, burning, erythema, or dryness at the application site; temporary numbness from lidocaine; mild skin bleaching with repeated hydrocortisone use over prolonged periods.

Store at room temperature (15–25°C), protected from heat and direct light. Keep tightly capped. Do not freeze. Keep out of reach of children. Observe the beyond-use date assigned by Genesis Compounding per USP <795>.

What does the lidocaine add to this cream?

Lidocaine provides local analgesia, reducing the burning, pain, and tingling associated with cold sore lesions. It complements acyclovir (which fights the virus) and hydrocortisone (which reduces inflammation) by addressing the symptom burden directly.

When should I start using this cream?

Start at the very first symptom — typically tingling, burning, or itching — before a visible lesion appears. Early initiation is key to maximizing antiviral efficacy and limiting lesion development.

Is this preparation FDA-approved?

No. This is a patient-specific, 503A compounded preparation from Genesis Compounding. The three-ingredient combination at these specific concentrations is not available as an FDA-approved product.

Can I use this if the sore has already ulcerated?

Yes, but early application produces better outcomes. Even during the ulcerative stage, continued application provides antiviral, anti-inflammatory, and analgesic benefits. Avoid applying directly inside open wounds or mucous membranes.

How do I store this properly?

At room temperature, away from direct light and heat. Do not refrigerate or freeze. Use before the beyond-use date labeled by Genesis Compounding and discard any unused cream after that date.