Ketotifen 0.05% | Oxymetazoline 0.06% | Tea Tree Oil 5%

Route: Topical periocular/eyelid margin application. Using a clean applicator (e.g., cotton-tipped swab or provided applicator), apply carefully along the upper and lower eyelid margins and lash bases as directed by the prescriber. Keep eyes closed during application. Do not allow product to enter the eye directly. Wash hands before and after. Do not use tea tree oil products orally — topical use only.

All dosing is prescriber-determined:

• Typically applied once or twice daily to the eyelid margins, for a minimum of 6–8 weeks (encompassing two Demodex mite life cycles for eradication).
• Ongoing maintenance frequency and duration are specified by the prescribing clinician.
• The oxymetazoline 0.06% concentration is consistent with topical rosacea/ocular vasoconstrictive dosing in the FDA-approved formulation range.

• Ketotifen 0.05%: Non-competitively antagonizes H1 histamine receptors in conjunctival and eyelid tissue, and stabilizes mast cells by blocking calcium influx required for degranulation. Also inhibits leukotriene-mediated and PAF-mediated inflammatory responses, and reduces eosinophil accumulation at the ocular surface.
• Oxymetazoline 0.06%: Binds alpha-1A adrenoceptors (via Gq/phospholipase C/IP3/Ca²⁺ pathway) and alpha-2B adrenoceptors (via Gi/adenylyl cyclase inhibition) on vascular smooth muscle of eyelid and conjunctival vasculature, producing vasoconstriction and reducing erythema and eyelid edema.
• Tea Tree Oil 5%: Primary active component terpinen-4-ol disrupts Demodex mite plasma and mitochondrial membranes, alters membrane permeability, and competitively inhibits acetylcholinesterases in the parasites, paralyzing and killing them. Terpinen-4-ol also suppresses monocyte-derived pro-inflammatory mediators (TNF-α, IL-1β, IL-10) and reduces reactive oxygen species, contributing to anti-inflammatory effects.

This formulation is indicated for prescriber-directed management of Demodex blepharitis complicated by allergic periocular disease and vascular hyperemia. Demodex folliculorum and Demodex brevis infestations of the eyelid are associated with blepharitis, meibomian gland dysfunction, and conjunctivitis. The combination of antiparasitic (TTO), anti-allergic (ketotifen), and vasoconstrictive (oxymetazoline) components provides multi-targeted treatment.

Monitoring: Slit-lamp examination for mite density reduction (epilation/counting technique); eyelid margin erythema; meibomian gland function; intraocular pressure (oxymetazoline may have mild mydriatic effects in susceptible patients); skin tolerance at application site. Prescribers should evaluate for narrow-angle glaucoma prior to initiating oxymetazoline.

Contraindications:

• Known hypersensitivity to any component (ketotifen, oxymetazoline, or components of tea tree oil including terpinen-4-ol).
• Narrow-angle glaucoma (oxymetazoline may cause mild pupillary dilation).
• Concurrent monoamine oxidase inhibitor (MAOI) therapy (risk of hypertensive crisis with sympathomimetics).

Warnings & Precautions:

• Do not allow product to enter the eye; tea tree oil at high concentrations is a direct ocular irritant.
• Prolonged oxymetazoline use may cause rebound vasodilation (rhinitis medicamentosa-like effect) with extended application to periocular tissue.
• Tea tree oil has been associated with allergic contact dermatitis and oxidation-related sensitization; use fresh product within beyond-use date.
• Ketotifen topical use: local irritation, stinging, and erythema at application site.

Drug Interactions:

• Oxymetazoline with MAOIs: contraindicated due to hypertensive crisis risk.
• Oxymetazoline with tricyclic antidepressants: potential for additive adrenergic effects.

Common Side Effects: Eyelid margin irritation, burning, or stinging upon application; mild erythema; tearing. Oxymetazoline: rebound erythema with extended use. Tea tree oil: rare contact sensitization.

Store at room temperature (15°C–25°C), protected from light and heat. Tea tree oil components are susceptible to oxidation; keep container tightly closed. Do not freeze. Oxidized tea tree oil is associated with increased skin sensitization. Use within the beyond-use date assigned by Genesis Compounding at dispensing.

What is this formula used for?

It is prescribed for management of Demodex blepharitis with associated allergic eyelid inflammation and vascular erythema. The tea tree oil component targets Demodex mites; ketotifen addresses allergic and mast-cell-driven inflammation; oxymetazoline reduces vascular hyperemia and erythema.

How long does treatment take?

Demodex eradication generally requires at least 6–8 weeks of consistent treatment to cover two complete mite life cycles. Your prescriber will determine the duration and any maintenance regimen.

Can the product enter the eye?

No. Apply only to the eyelid margin and lash bases with the eyes closed. Tea tree oil is a direct ocular irritant at this concentration. If eye contact occurs, flush immediately with copious water and contact your prescriber.

Is this FDA-approved?

No. This is a patient-specific, prescriber-directed 503A compounded preparation from Genesis Compounding, not FDA-approved as a compounded drug.

How should I store this preparation?

At room temperature, tightly sealed and protected from light. Tea tree oil oxidizes when exposed to air or light, which can increase the risk of skin sensitization. Always use before the beyond-use date on the label.