Acyclovir 6% | Hydrocortisone 1%

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

• Apply a thin layer to the lesion and immediately surrounding skin five times daily at approximately 3-hour intervals (while awake).
• Do not apply to mucous membranes or inside the mouth.
• Wash hands before and after application to prevent viral spread.
• Use as early as possible in the prodromal phase for maximum benefit.

Based on established clinical pharmacology for this ingredient combination:

• Apply topically five times daily for 5 days, initiating treatment at first sign of recurrence (prodromal symptoms).
• Do not use for longer than 10 days without prescriber reassessment.
• For recurrence prevention, consult prescriber regarding episodic versus suppressive antiviral strategies.
• Final dosing is prescriber-determined.

• Acyclovir: A synthetic purine deoxynucleoside analogue that is selectively phosphorylated by HSV thymidine kinase (TK) in infected cells. The resulting acyclovir triphosphate inhibits HSV DNA polymerase through three mechanisms: competitive inhibition, incorporation into the growing viral DNA chain (causing premature chain termination), and irreversible inactivation of viral DNA polymerase. Acyclovir has minimal activity in uninfected cells due to its low affinity for host cell kinases.
• Hydrocortisone: The principal endogenous glucocorticoid; binds glucocorticoid receptors in infected keratinocytes and local immune cells, suppressing NF-κB–mediated inflammatory gene transcription, reducing local cytokine production, prostaglandin synthesis, and immune cell recruitment that contribute to erythema, edema, and lesion ulceration.

This dual-component topical preparation addresses the two primary pathophysiologic drivers of herpes simplex labialis (HSL) recurrence:

• Viral replication (addressed by acyclovir) — primarily responsible for initial lesion formation and infectivity.
• Host immune-inflammatory response (addressed by hydrocortisone) — responsible for much of the erythema, edema, tenderness, and ulceration associated with cold sore lesions.

Clinical data for 5% acyclovir/1% hydrocortisone combinations (e.g., Xerese) have demonstrated reduction in both ulcerative and non-ulcerative lesion frequency and shortened healing time versus acyclovir alone.

Monitoring: This formulation at Acyclovir 6% (above the 5% reference preparation) is a higher-than-standard concentration; prescribers should assess for local tolerability. Monitoring for resistance is warranted in immunocompromised patients on long-term antiviral therapy.

Contraindications:

• Known hypersensitivity to acyclovir, valacyclovir, or hydrocortisone.
• Do not apply to the eyes or mucous membranes.

Warnings & Precautions:

• For external use only; avoid contact with eyes.
• Immunocompromised patients may require systemic antiviral therapy and should be monitored for resistance.
• Prolonged topical corticosteroid use (hydrocortisone) should be avoided, particularly on thin facial skin — standard treatment courses of 5 days minimize this risk.
• This is a 503A compounded preparation; acyclovir concentration (6%) exceeds the reference FDA-approved 5% topical product.

Drug Interactions:

• Topical drug interactions are minimal due to negligible systemic absorption of acyclovir and hydrocortisone at standard topical doses.

Common Side Effects: Local application site burning, stinging, erythema, dryness, or peeling at the application site; these are generally mild and transient.

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>.

When should I start applying this cream?

Begin applying at the very first sign of a cold sore recurrence — tingling, itching, or burning — before any visible lesion appears. Early treatment in the prodromal phase produces the best outcomes.

Why is hydrocortisone included with the antiviral?

Cold sore severity is driven not only by viral replication but also by the host immune-inflammatory response. Hydrocortisone suppresses the local inflammatory cascade, which can reduce lesion size, erythema, pain, and the likelihood of progression to ulceration.

Is this preparation FDA-approved?

No. This is a patient-specific, 503A compounded preparation from Genesis Compounding. An FDA-approved 5%/1% acyclovir/hydrocortisone cream (Xerese) exists; this preparation is compounded at a different concentration per prescriber specification.

Is it safe to use on my lips?

Apply only to the external lip and perioral skin surface. Do not apply inside the mouth, to mucous membranes, or to the eyes. Wash hands before and after each application.

Can I use this during pregnancy?

Consult your prescriber. Acyclovir systemic exposure from topical use is minimal; however, safety data for topical use during pregnancy are limited. Your prescriber will weigh risks and benefits.