Our Custom Rx Safety Information

Arousal Cream - Safety Data Sheet

Compound: L-Arginine 6% (60 mg/g) / Nifedipine 0.2% (2 mg/g) / Sildenafil 2% (20 mg/g) VersaPro Cream - 30 g
Dosage Form: Topical cream (compounded - not FDA-approved)
Typical Use: Prescriber-directed topical therapy for sexual dysfunction and/or peripheral vascular conditions.
Usual Directions (example): Apply thin layer to affected area as directed by prescriber; frequency individualized.

Key Components & Risks
- L-Arginine 6%: Nitric oxide precursor; generally well-tolerated; theoretical risk of systemic hypotension or GI upset if absorbed in large amounts.
- Nifedipine 0.2%: Calcium channel blocker; topical use may cause local redness, warmth, rare systemic absorption leading to hypotension, dizziness, flushing.
- Sildenafil 2%: PDE-5 inhibitor; topical use may lead to local irritation, rare systemic absorption causing headache, flushing, hypotension.

Contraindications
- Known hypersensitivity to any component.
- Concomitant nitrate or PDE-5 inhibitor therapy (risk of hypotension if systemic absorption occurs).
- Severe hypotension or unstable cardiovascular status.
- Pregnancy and breastfeeding (safety not established).

Warnings & Precautions
- Apply only to intact skin; avoid mucosal areas unless directed by prescriber.
- Potential for additive systemic hypotension when combined with oral antihypertensives, PDE-5 inhibitors, or nitrates.
- Wash hands thoroughly after application.
- Discontinue and consult prescriber if severe local irritation, dizziness, syncope, or chest pain occurs.

Drug/Skincare Interactions
- Nitrates (e.g., nitroglycerin) – contraindicated with sildenafil (risk of severe hypotension).
- Antihypertensives – possible additive hypotensive effects.
- Other topical vasodilators or irritants – increased risk of local dermatitis.

Adverse Effects (Selected)
- Local: erythema, burning, tingling, mild edema.
- Systemic (rare): headache, dizziness, hypotension, flushing, palpitations.
- GI upset possible if accidental oral ingestion.

Monitoring (Per Prescriber)
- Symptomatic improvement in circulation or erectile function (as indicated by use).
- Monitor for adverse effects including dizziness, flushing, or hypotension.
- Periodic blood pressure checks recommended if applied frequently or in large areas.

Patient Counseling Points
- Use only as directed by prescriber.
- Apply a thin layer to affected area; avoid eyes, mouth, and broken skin.
- Do not use concurrently with oral PDE-5 inhibitors or nitrates.
- Report severe dizziness, chest pain, or prolonged/ painful erection immediately.
- Store at room temperature; keep away from children and pets.

Storage & Handling
- Store at controlled room temperature (20–25 °C / 68–77 °F).
- Protect from excessive heat, light, and moisture.
- For external use only.

References (Selected)
- DailyMed: Sildenafil oral labeling (class warnings extrapolated to topical use).
- DailyMed: Nifedipine oral labeling (hypotension, vasodilatory effects).
- Clinical literature on topical L-Arginine for vasodilation and sexual dysfunction (adjunctive evidence).
- Compounded topical PDE-5 inhibitor formulations for erectile dysfunction and vascular disorders (limited clinical
studies).

Disclaimer: This document is for clinical reference by licensed healthcare professionals. It does not replace
prescriber judgment, patient-specific recommendations, or official labeling of individual drug products.