• For topical dermatological use only (2.1).
• Apply a thin film once daily to affected areas of the skin (2.1, 2.2).

• Gel: 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) in 60g tubes (3)

Severe hypersensitivity to mechlorethamine (4)
WARNINGS AND PRECAUTIONS

• Mucosal or eye injury: VALCHLOR exposure to mucous membranes, especially of the eyes, can cause mucosal injury which may be severe. Eye injury may lead to blindness. Immediately irrigate for at least 15 minutes followed by immediate medical consultation (5.1).
• Secondary exposure to VALCHLOR: individuals other than the patient must avoid skin contact with VALCHLOR (2.2, 5.2).
• Dermatitis: Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. Stop treatment or reduce dose frequency (2.1, 5.3).
• Non-melanoma skin cancer: Monitor patients during and after treatment (5.4).
• Embryo-fetal toxicity: Can cause fetal harm. Advise women of potential hazard to a fetus (5.5, 8.1).
• Flammable gel: VALCHLOR is an alcohol-based gel. Avoid fire, flame, and smoking until the gel has dried (2.2, 5.6).

The most common adverse reactions (≥5%) are dermatitis, pruritus, bacterial skin infection, skin ulceration or blistering, and hyperpigmentation (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Actelion Pharmaceuticals US, Inc., at 1-855-4-VALCHLOR (1-855-482-5245) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Nursing Mothers: Discontinue drug or nursing (5.2, 8.3).